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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03793166
Other study ID # NCI-2018-03694
Secondary ID NCI-2018-03694A0
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date June 7, 2019
Est. completion date September 15, 2024

Study information

Verified date May 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body.


Description:

PRIMARY OBJECTIVE: I. To compare the overall survival (OS) in patients with metastatic renal cell cancer (RCC) treated with ipilimumab-nivolumab followed by either nivolumab versus cabozantinib-nivolumab. SECONDARY OBJECTIVES: I. To determine progression free survival (PFS) of patients treated with nivolumab versus nivolumab-cabozantinib. II. To evaluate the 12-month complete response rate in patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab (patients who have complete response [CR] and relapse before 12 months will not be counted as a CR at 12-months). III. To evaluate the rates of discontinuing therapy at 1 year. IV. To compare objective response rates (ORR, assessed by Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 and Immune Response Evaluation Criteria in Solid Tumors [iRECIST] criteria) for patients treated with ipilimumab-nivolumab followed by cabozantinib-nivolumab versus ipilimumab-nivolumab followed by nivolumab. V. To document the adverse event profile of ipilimumab-nivolumab followed by cabozantinib-nivolumab. BIOMARKER OBJECTIVES: I. To evaluate biomarkers associated with exceptional responses in both arms (exceptional responses defined as CRs with treatment discontinuation at 12 months or 24 months). II. To evaluate whether baseline IL-6 is predictive of outcome in patients treated with cabozantinib-containing regimen. QUALITY OF LIFE (QOL) OBJECTIVES: I. To compare health-related quality of life at 18 months post-registration as assessed by the Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19 (FKSI-19) between patients randomized to nivolumab (nivo) versus (vs) cabozantinib (cabo)/nivo. II. To compare health-related quality of life as assessed by the FKSI-19 between patients randomized to nivo vs cabo/nivo at other time points. III. To compare patient-reported fatigue using Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue between patients randomized to nivo vs cabo/nivo. IV. To compare quality-adjusted survival (overall survival x utility score assessed by EuroQol five-dimensional questionnaire [EQ5D-5L]) between patients randomized to nivo vs cabo/nivo. OUTLINE: INDUCTION: Patients receive nivolumab intravenously (IV) over 30 minutes and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. TREATMENT: Patients with unconfirmed but clinical progression of disease (iuPD) with clinical instability receive cabozantinib orally (PO) daily on days 1-28. Treatment repeats every 28 days until further disease progression or unacceptable toxicity. Patients with unconfirmed CR (iCR) receive nivolumab IV between 30-60 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with non-CR/non-PD or iuPD with clinical stability are randomized to 1 of 2 arms. ARM A: Patients receive nivolumab IV between 30-60 minutes on day 1. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. ARM B: Patients receive nivolumab IV between 30-60 minutes on day 1 and cabozantinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI) and blood sample collection throughout the study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1175
Est. completion date September 15, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - STEP I REGISTRATION CRITERIA - Histologically documented renal cell carcinoma with clear cell component, including patients who have sarcomatoid or rhabdoid features - Any metastatic disease, including visceral, lymph node, other soft tissue and bone, measurable per RECIST 1.1. - Measurable disease as defined in the protocol. - Must be intermediate or poor risk patient per International Metastatic Renal Cell Carcinoma Database (IMDC) criteria (1 or more of the following): Karnofsky performance status [KPS] < 80, < 1 year from diagnosis [including initial nephrectomy] to systemic treatment for metastatic disease, hemoglobin less than lower limit of normal [LLN], corrected calcium concentration greater than upper limit of normal [ULN], absolute neutrophil count greater than ULN, platelet count > ULN). - Central nervous system (CNS) disease permitted, if stable and not otherwise causing symptoms or needing active treatment. - Karnofsky performance status >= 70%. - No prior treatment with PD-1, PD-L1, or CTLA-4 targeting agents (including but not limited to nivolumab, pembrolizumab, pidilizumab, durvalumab, atezolizumab, tremelimumab, and ipilimumab), or any other drug or antibody specifically targeting T-cell co-stimulation or checkpoint pathways. The only exception is for prior treatment with nivolumab or other PD-1/PD-L1/CTLA-4 targeting therapy on pre- or post-operative trials, as long as > 1 year since completion of systemic therapy. - No prior previous systemic therapy for renal cell carcinoma (prior HD IL-2 [> 28 days] and prior adjuvant sunitinib > 180 days since completion and prior immunotherapy as above are allowed). - No systemic cancer therapy less than 28 days prior to registration; no radiation therapy less than 14 days prior to registration. There must be a complete recovery and no ongoing complications from radiotherapy. - Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =< 14 days prior to registration is required. - Age >= 18 years - Absolute neutrophil count (ANC) >= 1,500/mm^3. - Platelet count >= 100,000/mm^3. - Hemoglobin >= 8 g/dL. - Calculated (Calc.) creatinine clearance >= 30 mL/min. - Urine protein =< 1+ or urine protein to creatinine (UPC) ratio < 1. - Total bilirubin =< 1.5 x upper limit of normal (ULN) (except for patients with known or likely Gilbert's syndrome, for whom total bilirubin up to 3 mg/dL is allowed with direct bilirubin =< 20% total bilirubin) - Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =< 2.5 x upper limit of normal (ULN) or < 5 x ULN if hepatic metastases present. - STEP 2 REGISTRATION ELIGIBILITY CRITERIA - Successful completion of at least 1 cycle of ipilimumab/nivolumab. - Resolution of any treatment-related adverse events to grade 1 or less per dose modification section (this criteria does not include any adverse events [AEs] not attributable to treatment which are present due to disease), with prednisone-equivalent dosing at 10 mg daily or less. Exceptions for this criteria include patients receiving replacement hormone treatments (such as levothyroxine for treatment-related hypothyroidism or glucocorticoid replacement for adrenal insufficiency). Please contact study chair if further discussion is needed. - No more than 80 days from last dose of ipilimumab/nivolumab. Exclusion Criteria: - Active autoimmune disease requiring ongoing therapy. - Ongoing acute toxicity > grade 2 from previous treatment. - History of severe allergic, anaphylactic or other hypersensitivity reactions to chimeric or humanized antibodies. - Active hepatitis B/C, or active tuberculosis (PPD response without active TB is allowed) - Human immunodeficiency virus (HIV) -infected patients with detectable viral load within 6 months prior to registration. Patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible. - Concurrent use of immunosuppressive medication including prednisone above 10 mg daily. - Uncontrolled adrenal insufficiency. - Uncontrolled hypertension (systolic blood pressure [BP] >150 mmHg or diastolic BP > 90 mmHg). - Major surgery less than 28 days prior to registration. - Any serious non-healing wound, ulcer, or bone fracture within 28 days prior to registration. - Any arterial thrombotic events within 180 days prior to registration. - Clinically significant hematuria, hematemesis, or hemoptysis within 12 weeks prior to registration. - Cavitating pulmonary lesions or known endotracheal or endobronchial disease manifestations. - Lesions encasing or invading any major blood vessels (this does not include tumor thrombus extending into/through renal vein/inferior vena cava [IVC]). Patients with tumor thrombus extending into/through renal vein are considered eligible. - Moderate of severe hepatic impairment (Child-Pugh B or C). - Any history of untreated pulmonary embolism or deep venous thrombosis (DVT) in the 180 days prior to registration. (Any asymptomatic, treated pulmonary embolism or asymptomatic, treated deep venous thrombosis > 30 days prior to registration allowed). - Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms. - Unstable cardiac arrhythmia within 6 months prior to registration. - Any gastrointestinal (GI) bleeding =< 180 days, hemoptysis, or other signs of pulmonary hemorrhage =< 90 days prior to registration. - History of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, bowel obstruction, or gastric outlet obstruction within 180 days prior to registration. - Active peptic ulcer disease, inflammatory bowel disease, or malabsorption syndrome within 28 days prior to registration. - Untreated hypothyroidism (treated hypothyroidism on thyroid replacement therapy is allowed. Abnormal thyroid-stimulating hormone (TSH) is acceptable with normal T3/free T4 if treated on thyroid replacement therapy) - Evidence of pancreatitis, history of organ transplant, or history of congenital QT syndrome. - Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Allowed also in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor. - Significant cardiac ischemia events (ST elevation myocardial infarction [STEMI] or non-ST elevation myocardial infarction [NSTEMI]) within 6 months or active NY Heart Association class 3-4 heart failure symptoms

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Drug:
Cabozantinib
Given PO
Procedure:
Computed Tomography
Undergo CT scan
Biological:
Ipilimumab
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Biological:
Nivolumab
Given IV
Other:
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Puerto Rico Pan American Center for Oncology Trials LLC San Juan
United States Hawaii Cancer Care - Westridge 'Aiea Hawaii
United States Pali Momi Medical Center 'Aiea Hawaii
United States Queen's Cancer Center - Pearlridge 'Aiea Hawaii
United States The Cancer Center of Hawaii-Pali Momi 'Aiea Hawaii
United States Avera Cancer Institute-Aberdeen Aberdeen South Dakota
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hickman Cancer Center Adrian Michigan
United States Riverwood Healthcare Center Aitkin Minnesota
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States University Cancer Specialists - Alcoa Alcoa Tennessee
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
United States Saint Anthony's Health Alton Illinois
United States American Fork Hospital / Huntsman Intermountain Cancer Center American Fork Utah
United States Mary Greeley Medical Center Ames Iowa
United States McFarland Clinic - Ames Ames Iowa
United States Community Hospital of Anaconda Anaconda Montana
United States Kaiser Permanente-Anaheim Anaheim California
United States Alaska Breast Care and Surgery LLC Anchorage Alaska
United States Alaska Oncology and Hematology LLC Anchorage Alaska
United States Alaska Women's Cancer Care Anchorage Alaska
United States Anchorage Associates in Radiation Medicine Anchorage Alaska
United States Anchorage Oncology Centre Anchorage Alaska
United States Anchorage Radiation Therapy Center Anchorage Alaska
United States Katmai Oncology Group Anchorage Alaska
United States Providence Alaska Medical Center Anchorage Alaska
United States Mission Cancer and Blood - Ankeny Ankeny Iowa
United States Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States ThedaCare Regional Cancer Center Appleton Wisconsin
United States Mission Hope Medical Oncology - Arroyo Grande Arroyo Grande California
United States PCR Oncology Arroyo Grande California
United States AdventHealth Infusion Center Asheville Asheville North Carolina
United States Duluth Clinic Ashland Ashland Wisconsin
United States Northwest Wisconsin Cancer Center Ashland Wisconsin
United States Northside Hospital Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States MultiCare Auburn Medical Center Auburn Washington
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rocky Mountain Cancer Centers-Aurora Aurora Colorado
United States Rush - Copley Medical Center Aurora Illinois
United States The Medical Center of Aurora Aurora Colorado
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Dell Seton Medical Center at The University of Texas Austin Texas
United States Saint Alphonsus Cancer Care Center-Baker City Baker City Oregon
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Greater Baltimore Medical Center Baltimore Maryland
United States Flaget Memorial Hospital Bardstown Kentucky
United States Hematology/Oncology Clinic PLLC Baton Rouge Louisiana
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Ochsner High Grove Baton Rouge Louisiana
United States Our Lady of The Lake Baton Rouge Louisiana
United States Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States Bronson Battle Creek Battle Creek Michigan
United States Indu and Raj Soin Medical Center Beavercreek Ohio
United States Waldo County General Hospital Belfast Maine
United States Nebraska Medicine-Bellevue Bellevue Nebraska
United States Overlake Medical Center Bellevue Washington
United States Kaiser Permanente-Bellflower Bellflower California
United States PeaceHealth Saint Joseph Medical Center Bellingham Washington
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Saint Charles Health System Bend Oregon
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford Biddeford Maine
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Frontier Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Elizabeth Boardman Hospital Boardman Ohio
United States Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Central Care Cancer Center - Bolivar Bolivar Missouri
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Boulder Community Foothills Hospital Boulder Colorado
United States Boulder Community Hospital Boulder Colorado
United States Rocky Mountain Cancer Centers-Boulder Boulder Colorado
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Essentia Health Saint Joseph's Medical Center Brainerd Minnesota
United States Cox Cancer Center Branson Branson Missouri
United States Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States Ocean University Medical Center Brick New Jersey
United States United Hospital Center Bridgeport West Virginia
United States Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan
United States Trinity Health Medical Center - Brighton Brighton Michigan
United States Bristol Regional Medical Center Bristol Tennessee
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States Montefiore Medical Center - Moses Campus Bronx New York
United States Montefiore Medical Center-Einstein Campus Bronx New York
United States Montefiore Medical Center-Weiler Hospital Bronx New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Bryn Mawr Hospital Bryn Mawr Pennsylvania
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
United States University of Vermont and State Agricultural College Burlington Vermont
United States University of Vermont Medical Center Burlington Vermont
United States Fairview Ridges Hospital Burnsville Minnesota
United States Minnesota Oncology - Burnsville Burnsville Minnesota
United States Loyola Center for Health at Burr Ridge Burr Ridge Illinois
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho
United States Cambridge Medical Center Cambridge Minnesota
United States Illinois CancerCare-Canton Canton Illinois
United States Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan
United States Trinity Health Medical Center - Canton Canton Michigan
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States AtlantiCare Health Park-Cape May Court House Cape May Court House New Jersey
United States Memorial Hospital of Carbondale Carbondale Illinois
United States Caro Cancer Center Caro Michigan
United States Saint Anthony Regional Hospital Carroll Iowa
United States Carson Tahoe Regional Medical Center Carson City Nevada
United States SIH Cancer Institute Carterville Illinois
United States Illinois CancerCare-Carthage Carthage Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Rocky Mountain Cancer Centers - Centennial Centennial Colorado
United States Dayton Physicians LLC-Miami Valley South Centerville Ohio
United States Miami Valley Hospital South Centerville Ohio
United States Centralia Oncology Clinic Centralia Illinois
United States Providence Regional Cancer System-Centralia Centralia Washington
United States Christiana Care Health System-Concord Health Center Chadds Ford Pennsylvania
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Medical University of South Carolina Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Chelsea Hospital Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Saint Luke's Hospital Chesterfield Missouri
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
United States John H Stroger Jr Hospital of Cook County Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Bethesda North Hospital Cincinnati Ohio
United States Good Samaritan Hospital - Cincinnati Cincinnati Ohio
United States Oncology Hematology Care Inc-Kenwood Cincinnati Ohio
United States TriHealth Cancer Institute-Anderson Cincinnati Ohio
United States TriHealth Cancer Institute-Westside Cincinnati Ohio
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Providence Cancer Institute Clackamas Clinic Clackamas Oregon
United States Hematology Oncology Consultants-Clarkston Clarkston Michigan
United States Newland Medical Associates-Clarkston Clarkston Michigan
United States Wake Forest University at Clemmons Clemmons North Carolina
United States MetroHealth Medical Center Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Henry Ford Macomb Hospital-Clinton Township Clinton Township Michigan
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Community Cancer Institute Clovis California
United States University Oncology Associates Clovis California
United States AdventHealth Infusion Center Haywood Clyde North Carolina
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Main Line Health Center-Collegeville Collegeville Pennsylvania
United States Baptist Memorial Hospital and Cancer Center-Collierville Collierville Tennessee
United States Memorial Hospital North Colorado Springs Colorado
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
United States MU Health - University Hospital/Ellis Fischel Cancer Center Columbia Missouri
United States Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus Mississippi
United States Columbus Oncology and Hematology Associates Inc Columbus Ohio
United States Doctors Hospital Columbus Ohio
United States Grant Medical Center Columbus Ohio
United States Mount Carmel East Hospital Columbus Ohio
United States Mount Carmel Health Center West Columbus Ohio
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States Riverside Methodist Hospital Columbus Ohio
United States The Mark H Zangmeister Center Columbus Ohio
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Cookeville Regional Medical Center Cookeville Tennessee
United States Mercy Hospital Coon Rapids Minnesota
United States Mary Imogene Bassett Hospital Cooperstown New York
United States Bay Area Hospital Coos Bay Oregon
United States UM Sylvester Comprehensive Cancer Center at Coral Gables Coral Gables Florida
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Ochsner Hematology Oncology North Shore - Covington (West Region) Covington Louisiana
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Parkland Memorial Hospital Dallas Texas
United States UT Southwestern Simmons Cancer Center - RedBird Dallas Texas
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Good Samaritan Hospital - Dayton Dayton Ohio
United States Miami Valley Hospital Dayton Ohio
United States Miami Valley Hospital North Dayton Ohio
United States Premier Blood and Cancer Center Dayton Ohio
United States Henry Ford Medical Center-Fairlane Dearborn Michigan
United States Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Essentia Health - Deer River Clinic Deer River Minnesota
United States UM Sylvester Comprehensive Cancer Center at Deerfield Beach Deerfield Beach Florida
United States Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Cancer Center of Colorado at Sloan's Lake Denver Colorado
United States Colorado Blood Cancer Institute Denver Colorado
United States Kaiser Permanente-Franklin Denver Colorado
United States National Jewish Health-Main Campus Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado
United States Rocky Mountain Cancer Centers-Midtown Denver Colorado
United States Rocky Mountain Cancer Centers-Rose Denver Colorado
United States Rose Medical Center Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
United States The Women's Imaging Center Denver Colorado
United States UCHealth - Cherry Creek Denver Colorado
United States Western Surgical Care Denver Colorado
United States Broadlawns Medical Center Des Moines Iowa
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Des Moines Des Moines Iowa
United States Mission Cancer and Blood - Laurel Des Moines Iowa
United States Ascension Saint John Hospital Detroit Michigan
United States Henry Ford Hospital Detroit Michigan
United States Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota
United States Illinois CancerCare-Dixon Dixon Illinois
United States Columbus Oncology and Hematology Associates Dublin Ohio
United States Dublin Methodist Hospital Dublin Ohio
United States Essentia Health Cancer Center Duluth Minnesota
United States Essentia Health Saint Mary's Medical Center Duluth Minnesota
United States Miller-Dwan Hospital Duluth Minnesota
United States Northside Hospital - Duluth Duluth Georgia
United States Mercy Medical Center Durango Colorado
United States Southwest Oncology PC Durango Colorado
United States Duke University Medical Center Durham North Carolina
United States Durham VA Medical Center Durham North Carolina
United States Prisma Health Cancer Institute - Easley Easley South Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Pocono Medical Center East Stroudsburg Pennsylvania
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Swedish Cancer Institute-Edmonds Edmonds Washington
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States AtlantiCare Surgery Center Egg Harbor Township New Jersey
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Walter Knox Memorial Hospital Emmett Idaho
United States Mountain Blue Cancer Care Center - Swedish Englewood Colorado
United States Rocky Mountain Cancer Centers - Swedish Englewood Colorado
United States Swedish Medical Center Englewood Colorado
United States The Melanoma and Skin Cancer Institute Englewood Colorado
United States Saint Elizabeth Hospital Enumclaw Washington
United States OSF Saint Francis Hospital and Medical Group Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Main Line Health Center-Exton Exton Pennsylvania
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States University of Kansas Clinical Research Center Fairway Kansas
United States Essentia Health Cancer Center-South University Clinic Fargo North Dakota
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Medical Center Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
United States Sanford South University Medical Center Fargo North Dakota
United States Southpointe-Sanford Medical Center Fargo Fargo North Dakota
United States Parkland Health Center - Farmington Farmington Missouri
United States Highlands Oncology Group - Fayetteville Fayetteville Arkansas
United States Saint Francis Hospital Federal Way Washington
United States Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota
United States Armes Family Cancer Center Findlay Ohio
United States Blanchard Valley Hospital Findlay Ohio
United States Orion Cancer Care Findlay Ohio
United States Augusta Health Center for Cancer and Blood Disorders Fishersville Virginia
United States Genesee Cancer and Blood Disease Treatment Center Flint Michigan
United States Genesee Hematology Oncology PC Flint Michigan
United States Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Kaiser Permanente-Fontana Fontana California
United States Cancer Care and Hematology-Fort Collins Fort Collins Colorado
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Trinity Regional Medical Center Fort Dodge Iowa
United States Holy Cross Hospital Fort Lauderdale Florida
United States Mercy Hospital Fort Smith Fort Smith Arkansas
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Essentia Health - Fosston Fosston Minnesota
United States Beebe South Coastal Health Campus Frankford Delaware
United States Atrium Medical Center-Middletown Regional Hospital Franklin Ohio
United States Dayton Physicians LLC-Atrium Franklin Ohio
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Gibbs Cancer Center-Gaffney Gaffney South Carolina
United States Central Ohio Breast and Endocrine Surgery Gahanna Ohio
United States University of Florida Health Science Center - Gainesville Gainesville Florida
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States University of Texas Medical Branch Galveston Texas
United States Central Care Cancer Center - Garden City Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Glens Falls Hospital Glens Falls New York
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Altru Cancer Center Grand Forks North Dakota
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Saint Mary's Hospital and Regional Medical Center Grand Junction Colorado
United States Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids Michigan
United States Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids Michigan
United States Trinity Health Grand Rapids Hospital Grand Rapids Michigan
United States Central Care Cancer Center - Great Bend Great Bend Kansas
United States Benefis Sletten Cancer Institute Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Banner North Colorado Medical Center Greeley Colorado
United States UCHealth Greeley Hospital Greeley Colorado
United States Bellin Memorial Hospital Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Saint Mary's Green Bay Wisconsin
United States Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin
United States Dayton Physicians LLC-Wayne Greenville Ohio
United States ECU Health Medical Center Greenville North Carolina
United States Miami Valley Cancer Care and Infusion Greenville Ohio
United States Prisma Health Cancer Institute - Butternut Greenville South Carolina
United States Prisma Health Cancer Institute - Eastside Greenville South Carolina
United States Prisma Health Cancer Institute - Faris Greenville South Carolina
United States Prisma Health Greenville Memorial Hospital Greenville South Carolina
United States Saint Francis Cancer Center Greenville South Carolina
United States Saint Francis Hospital Greenville South Carolina
United States Wayne Hospital Greenville Ohio
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
United States Baptist Cancer Center-Grenada Grenada Mississippi
United States Legacy Mount Hood Medical Center Gresham Oregon
United States Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan
United States Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan
United States Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan
United States Mount Carmel Grove City Hospital Grove City Ohio
United States Gulfport Memorial Hospital Gulfport Mississippi
United States Hackensack University Medical Center Hackensack New Jersey
United States Kaiser Permanente - Harbor City Harbor City California
United States Ingalls Memorial Hospital Harvey Illinois
United States HaysMed Hays Kansas
United States Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania
United States Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania
United States Saint Peter's Community Hospital Helena Montana
United States Cancer and Blood Specialists-Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada - Henderson Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Horizon Ridge Henderson Nevada
United States Comprehensive Cancer Centers of Nevada-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Las Vegas Urology - Green Valley Henderson Nevada
United States Las Vegas Urology - Pebble Henderson Nevada
United States OptumCare Cancer Care at Seven Hills Henderson Nevada
United States Urology Specialists of Nevada - Green Valley Henderson Nevada
United States AdventHealth Hendersonville Hendersonville North Carolina
United States Margaret R Pardee Memorial Hospital Hendersonville North Carolina
United States Penn State Milton S Hershey Medical Center Hershey Pennsylvania
United States Essentia Health Hibbing Clinic Hibbing Minnesota
United States UCHealth Highlands Ranch Hospital Highlands Ranch Colorado
United States Loyola Medicine Homer Glen Homer Glen Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Island Urology Honolulu Hawaii
United States Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Queen's Cancer Cenrer - POB I Honolulu Hawaii
United States Queen's Cancer Center - Kuakini Honolulu Hawaii
United States Queen's Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States The Cancer Center of Hawaii-Liliha Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas
United States Oncology Center of The South Incorporated Houma Louisiana
United States Terrebonne General Medical Center Houma Louisiana
United States Memorial Hermann Texas Medical Center Houston Texas
United States Novant Health Cancer Institute - Huntersville Huntersville North Carolina
United States Novant Health Presbyterian Medical Center Huntersville Huntersville North Carolina
United States Edwards Comprehensive Cancer Center Huntington West Virginia
United States Centerpoint Medical Center LLC Independence Missouri
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Sidney and Lois Eskenazi Hospital Indianapolis Indiana
United States Kaiser Permanente-Irvine Irvine California
United States Swedish Cancer Institute-Issaquah Issaquah Washington
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina
United States Essentia Health - Jamestown Clinic Jamestown North Dakota
United States McFarland Clinic - Jefferson Jefferson Iowa
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States Duly Health and Care Joliet Joliet Illinois
United States Freeman Health System Joplin Missouri
United States Mercy Hospital Joplin Joplin Missouri
United States Ascension Borgess Cancer Center Kalamazoo Michigan
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Research Medical Center Kansas City Missouri
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center - North Kansas City Missouri
United States CHI Health Good Samaritan Kearney Nebraska
United States ECU Health Oncology Kenansville Kenansville North Carolina
United States Kadlec Clinic Hematology and Oncology Kennewick Washington
United States Novant Health Cancer Institute - Kernersville Kernersville North Carolina
United States First Dayton Cancer Care Kettering Ohio
United States Greater Dayton Cancer Center Kettering Ohio
United States Kettering Medical Center Kettering Ohio
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kingman Regional Medical Center Kingman Arizona
United States Ballad Health Cancer Care - Kingsport Kingsport Tennessee
United States Wellmont Holston Valley Hospital and Medical Center Kingsport Tennessee
United States ECU Health Oncology Kinston Kinston North Carolina
United States University of Tennessee - Knoxville Knoxville Tennessee
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Good Samaritan Medical Center Lafayette Colorado
United States Kaiser Permanente-Rock Creek Lafayette Colorado
United States Northwestern Medicine Lake Forest Hospital Lake Forest Illinois
United States Northwell Health/Center for Advanced Medicine Lake Success New York
United States Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado
United States Saint Anthony Hospital Lakewood Colorado
United States Saint Clare Hospital Lakewood Washington
United States Fairfield Medical Center Lancaster Ohio
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Doctor's Hospital of Laredo Laredo Texas
United States Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas Nevada
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer and Blood Specialists-Shadow Las Vegas Nevada
United States Cancer and Blood Specialists-Tenaya Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Central Valley Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Northwest Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada - Town Center Las Vegas Nevada
United States Comprehensive Cancer Centers of Nevada-Summerlin Las Vegas Nevada
United States Desert West Surgery Las Vegas Nevada
United States GenesisCare USA - Fort Apache Las Vegas Nevada
United States GenesisCare USA - Las Vegas Las Vegas Nevada
United States GenesisCare USA - Vegas Tenaya Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-San Martin Las Vegas Nevada
United States HealthCare Partners Medical Group Oncology/Hematology-Tenaya Las Vegas Nevada
United States Hope Cancer Care of Nevada Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States Las Vegas Prostate Cancer Center Las Vegas Nevada
United States Las Vegas Urology - Cathedral Rock Las Vegas Nevada
United States Las Vegas Urology - Pecos Las Vegas Nevada
United States Las Vegas Urology - Smoke Ranch Las Vegas Nevada
United States Las Vegas Urology - Sunset Las Vegas Nevada
United States OptumCare Cancer Care at Charleston Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States OptumCare Cancer Care at MountainView Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Central Las Vegas Nevada
United States Radiation Oncology Centers of Nevada Southeast Las Vegas Nevada
United States Summerlin Hospital Medical Center Las Vegas Nevada
United States Sunrise Hospital and Medical Center Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Urology Specialists of Nevada - Central Las Vegas Nevada
United States Urology Specialists of Nevada - Northwest Las Vegas Nevada
United States Urology Specialists of Nevada - Southwest Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Northside Hospital - Gwinnett Lawrenceville Georgia
United States Cancer Centers of Southwest Oklahoma Research Lawton Oklahoma
United States University of Kansas Cancer Center - Lee's Summit Lee's Summit Missouri
United States Kansas Institute of Medicine Cancer and Blood Center Lenexa Kansas
United States Minimally Invasive Surgery Hospital Lenexa Kansas
United States Beebe Medical Center Lewes Delaware
United States Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania
United States Lewistown Hospital Lewistown Pennsylvania
United States Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Wilcox Memorial Hospital and Kauai Medical Clinic Lihue Hawaii
United States Saint Rita's Medical Center Lima Ohio
United States Cancer Partners of Nebraska Lincoln Nebraska
United States Cancer Partners of Nebraska - Pine Lake Lincoln Nebraska
United States Saint Elizabeth Regional Medical Center Lincoln Nebraska
United States Littleton Adventist Hospital Littleton Colorado
United States Rocky Mountain Cancer Centers-Littleton Littleton Colorado
United States Saint Barnabas Medical Center Livingston New Jersey
United States Hope Cancer Clinic Livonia Michigan
United States Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan
United States Logan Regional Hospital Logan Utah
United States Saint Joseph London London Kentucky
United States Kaiser Permanente-Lone Tree Lone Tree Colorado
United States Rocky Mountain Cancer Centers-Sky Ridge Lone Tree Colorado
United States Sky Ridge Medical Center Lone Tree Colorado
United States UCHealth Lone Tree Health Center Lone Tree Colorado
United States Longmont United Hospital Longmont Colorado
United States Rocky Mountain Cancer Centers-Longmont Longmont Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States Baptist Health Louisville Louisville Kentucky
United States Jewish Hospital Louisville Kentucky
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
United States Banner McKee Medical Center Loveland Colorado
United States Medical Center of the Rockies Loveland Colorado
United States Centra Alan B Pearson Regional Cancer Center Lynchburg Virginia
United States Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan
United States Illinois CancerCare-Macomb Macomb Illinois
United States Michigan Breast Specialists-Macomb Township Macomb Michigan
United States SSM Health Dean Medical Group - South Madison Campus Madison Wisconsin
United States University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Southern Ocean County Medical Center Manahawkin New Jersey
United States Elliot Hospital Manchester New Hampshire
United States Solinsky Center for Cancer Care Manchester New Hampshire
United States Holy Family Memorial Hospital Manitowoc Wisconsin
United States OhioHealth Mansfield Hospital Mansfield Ohio
United States Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota
United States Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota
United States Saint John's Hospital - Healtheast Maplewood Minnesota
United States Marietta Memorial Hospital Marietta Ohio
United States Saint Vincent Hospital Cancer Center at Marinette Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States WVUH-Berkely Medical Center Martinsburg West Virginia
United States Memorial Hospital Marysville Ohio
United States Novant Health Cancer Institute - Matthews Matthews North Carolina
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Loyola University Medical Center Maywood Illinois
United States Bon Secours Memorial Regional Medical Center Mechanicsville Virginia
United States Aspirus Medford Hospital Medford Wisconsin
United States Riddle Memorial Hospital Media Pennsylvania
United States Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park Illinois
United States Baptist Memorial Hospital and Cancer Center-Memphis Memphis Tennessee
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Idaho Urologic Institute-Meridian Meridian Idaho
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States East Jefferson General Hospital Metairie Louisiana
United States LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana
United States UM Sylvester Comprehensive Cancer Center at Kendall Miami Florida
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Woodland Cancer Care Center Michigan City Indiana
United States Bon Secours Saint Francis Medical Center Midlothian Virginia
United States Bon Secours Westchester Emergency Center Midlothian Virginia
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Health Partners Inc Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Minneapolis VA Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Trinity Cancer Care Center Minot North Dakota
United States Community Medical Center Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States University of South Alabama Mitchell Cancer Institute Mobile Alabama
United States Ochsner LSU Health Monroe Medical Center Monroe Louisiana
United States Toledo Clinic Cancer Centers-Monroe Monroe Michigan
United States Monticello Cancer Center Monticello Minnesota
United States Franciscan Health Mooresville Mooresville Indiana
United States Novant Health Cancer Institute - Mooresville Mooresville North Carolina
United States West Virginia University Healthcare Morgantown West Virginia
United States Novant Health Cancer Institute - Mount Airy Mount Airy North Carolina
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States Knox Community Hospital Mount Vernon Ohio
United States ProHealth D N Greenwald Center Mukwonago Wisconsin
United States Inspira Medical Center Mullica Hill Mullica Hill New Jersey
United States Intermountain Medical Center Murray Utah
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Alphonsus Cancer Care Center-Nampa Nampa Idaho
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Edward Hospital/Cancer Center Naperville Illinois
United States Jersey Shore Medical Center Neptune New Jersey
United States Baptist Memorial Hospital and Cancer Center-Union County New Albany Mississippi
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Louisiana State University Health Science Center New Orleans Louisiana
United States Ochsner Medical Center Jefferson New Orleans Louisiana
United States Touro Infirmary New Orleans Louisiana
United States Tulane University School of Medicine New Orleans Louisiana
United States University Medical Center New Orleans New Orleans Louisiana
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States New Ulm Medical Center New Ulm Minnesota
United States NYP/Weill Cornell Medical Center New York New York
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Delaware Clinical and Laboratory Physicians PA Newark Delaware
United States Helen F Graham Cancer Center Newark Delaware
United States Licking Memorial Hospital Newark Ohio
United States Medical Oncology Hematology Consultants PA Newark Delaware
United States Newark Radiation Oncology Newark Ohio
United States Providence Newberg Medical Center Newberg Oregon
United States Dana-Farber Cancer Institute - Chestnut Hill Newton Massachusetts
United States Bryn Mawr Health Center Newtown Square Pennsylvania
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Bon Secours DePaul Medical Center Norfolk Virginia
United States University of Kansas Cancer Center at North Kansas City Hospital North Kansas City Missouri
United States Southwest VA Regional Cancer Center Norton Virginia
United States Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores Michigan
United States Stephens Memorial Hospital Norway Maine
United States Ascension Providence Hospitals - Novi Novi Michigan
United States Henry Ford Medical Center-Columbus Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States ProHealth Oconomowoc Memorial Hospital Oconomowoc Wisconsin
United States Saint Vincent Hospital Cancer Center at Oconto Falls Oconto Falls Wisconsin
United States McKay-Dee Hospital Center Ogden Utah
United States Mercy Hospital Oklahoma City Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Olathe Health Cancer Center Olathe Kansas
United States Alegent Health Bergan Mercy Medical Center Omaha Nebraska
United States Alegent Health Immanuel Medical Center Omaha Nebraska
United States Alegent Health Lakeside Hospital Omaha Nebraska
United States Creighton University Medical Center Omaha Nebraska
United States Nebraska Cancer Specialists/Oncology Hematology West PC - MECC Omaha Nebraska
United States Nebraska Medicine-Village Pointe Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Oncology Associates PC Omaha Nebraska
United States University of Nebraska Medical Center Omaha Nebraska
United States Kaiser Permanente-Ontario Ontario California
United States Saint Alphonsus Cancer Care Center-Ontario Ontario Oregon
United States Providence Willamette Falls Medical Center Oregon City Oregon
United States Northwestern Medicine Orland Park Orland Park Illinois
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Orlando Health Cancer Institute Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Kaiser Permanente - Panorama City Panorama City California
United States Paoli Memorial Hospital Paoli Pennsylvania
United States Midlands Community Hospital Papillion Nebraska
United States Essentia Health - Park Rapids Park Rapids Minnesota
United States Parker Adventist Hospital Parker Colorado
United States Camden Clark Medical Center Parkersburg West Virginia
United States Cancer Center of Kansas - Parsons Parsons Kansas
United States Illinois CancerCare-Pekin Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Mercy Health Perrysburg Cancer Center Perrysburg Ohio
United States Illinois CancerCare-Peru Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Jefferson Methodist Hospital Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Freeman Physician Group of Pittsburg Pittsburg Kansas
United States Edward Hospital/Cancer Center?Plainfield Plainfield Illinois
United States UM Sylvester Comprehensive Cancer Center at Plantation Plantation Florida
United States Hope Cancer Center Pontiac Michigan
United States Michigan Healthcare Professionals Pontiac Pontiac Michigan
United States Newland Medical Associates-Pontiac Pontiac Michigan
United States Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac Michigan
United States Huron Medical Center PC Port Huron Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Jefferson Healthcare Port Townsend Washington
United States Legacy Good Samaritan Hospital and Medical Center Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Bon Secours Maryview Medical Center Portsmouth Virginia
United States Southern Ohio Medical Center Portsmouth Ohio
United States Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho
United States Geisinger Cancer Services-Pottsville Pottsville Pennsylvania
United States Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington
United States Fairview Northland Medical Center Princeton Minnesota
United States Illinois CancerCare-Princeton Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States Saint Mary Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Rapid City Regional Hospital Rapid City South Dakota
United States Riverview Medical Center/Booker Cancer Center Red Bank New Jersey
United States Saint Charles Health System-Redmond Redmond Oregon
United States Corewell Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Radiation Oncology Associates Reno Nevada
United States Renown Regional Medical Center Reno Nevada
United States Saint Mary's Regional Medical Center Reno Nevada
United States Valley Medical Center Renton Washington
United States Ascension Saint Mary's Hospital Rhinelander Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States UT Southwestern Clinical Center at Richardson/Plano Richardson Texas
United States ECU Health Oncology Richlands Richlands North Carolina
United States Bon Secours Cancer Institute at Reynolds Crossing Richmond Virginia
United States Bon Secours Saint Mary's Hospital Richmond Virginia
United States Reid Health Richmond Indiana
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States Riverton Hospital Riverton Utah
United States North Memorial Medical Health Center Robbinsdale Minnesota
United States University of Rochester Rochester New York
United States Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan
United States UW Health Carbone Cancer Center Rockford Rockford Illinois
United States Penobscot Bay Medical Center Rockport Maine
United States Highlands Oncology Group - Rogers Rogers Arkansas
United States Delbert Day Cancer Institute at PCRMC Rolla Missouri
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan
United States Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota
United States Saint George Regional Medical Center Saint George Utah
United States Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph Michigan
United States Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph Michigan
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Mercy Hospital South Saint Louis Missouri
United States Missouri Baptist Medical Center Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Siteman Cancer Center at Christian Hospital Saint Louis Missouri
United States Siteman Cancer Center-South County Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota
United States Regions Hospital Saint Paul Minnesota
United States United Hospital Saint Paul Minnesota
United States Siteman Cancer Center at Saint Peters Hospital Saint Peters Missouri
United States Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Salina Regional Health Center Salina Kansas
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Kaiser Permanente-San Diego Mission San Diego California
United States Kaiser Permanente-San Diego Zion San Diego California
United States Naval Medical Center -San Diego San Diego California
United States Sharp Memorial Hospital San Diego California
United States UCSF Medical Center-Mission Bay San Francisco California
United States Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kootenai Clinic Cancer Services - Sandpoint Sandpoint Idaho
United States Essentia Health Sandstone Sandstone Minnesota
United States MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford Sanford Maine
United States Mission Hope Medical Oncology - Santa Maria Santa Maria California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Guthrie Medical Group PC-Robert Packer Hospital Sayre Pennsylvania
United States Community Medical Center Scranton Pennsylvania
United States TidalHealth Nanticoke / Allen Cancer Center Seaford Delaware
United States Pacific Gynecology Specialists Seattle Washington
United States Swedish Medical Center-Ballard Campus Seattle Washington
United States Swedish Medical Center-Cherry Hill Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States PeaceHealth United General Medical Center Sedro-Woolley Washington
United States Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania
United States Prisma Health Cancer Institute - Seneca Seneca South Carolina
United States Saint Francis Regional Medical Center Shakopee Minnesota
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Henry Ford Macomb Health Center - Shelby Township Shelby Michigan
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Jewish Hospital Medical Center South Shepherdsville Kentucky
United States Welch Cancer Center Sheridan Wyoming
United States Memorial Hospital East Shiloh Illinois
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
United States Saint Michael Cancer Center Silverdale Washington
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Avera Cancer Institute Sioux Falls South Dakota
United States Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota
United States Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota
United States Suburban Hematology Oncology Associates - Snellville Snellville Georgia
United States VCU Community Memorial Health Center South Hill Virginia
United States Maine Medical Partners - South Portland South Portland Maine
United States Ascension Providence Hospitals - Southfield Southfield Michigan
United States Baptist Memorial Hospital and Cancer Center-Desoto Southhaven Mississippi
United States North Grove Medical Park Spartanburg South Carolina
United States Spartanburg Medical Center Spartanburg South Carolina
United States Spartanburg Medical Center - Mary Black Campus Spartanburg South Carolina
United States MultiCare Deaconess Cancer and Blood Specialty Center - Downtown Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - North Spokane Washington
United States MultiCare Deaconess Cancer and Blood Specialty Center - Valley Spokane Valley Washington
United States Highlands Oncology Group Springdale Arkansas
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Mercy Medical Center Springfield Massachusetts
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Springfield Regional Cancer Center Springfield Ohio
United States Springfield Regional Medical Center Springfield Ohio
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Geisinger Medical Group State College Pennsylvania
United States Novant Health Cancer Institute - Statesville Statesville North Carolina
United States Wake Forest Baptist Health - Hematology Oncology - Statesville Statesville North Carolina
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
United States Lakeview Hospital Stillwater Minnesota
United States Stony Brook University Medical Center Stony Brook New York
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Bon Secours Health Center at Harbour View Suffolk Virginia
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States BJC Outpatient Center at Sunset Hills Sunset Hills Missouri
United States Southwest Illinois Health Services LLP Swansea Illinois
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States Franciscan Research Center-Northwest Medical Plaza Tacoma Washington
United States Mary Bridge Children's Hospital and Health Center Tacoma Washington
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest Medical Specialties PLLC Tacoma Washington
United States Ascension Saint Joseph Hospital Tawas City Michigan
United States Sanford Thief River Falls Medical Center Thief River Falls Minnesota
United States Novant Health Cancer Institute - Thomasville Thomasville North Carolina
United States National Jewish Health-Northern Hematology Oncology Thornton Colorado
United States Rocky Mountain Cancer Centers-Thornton Thornton Colorado
United States Mercy Health - Saint Anne Hospital Toledo Ohio
United States Mercy Health - Saint Vincent Hospital Toledo Ohio
United States Toledo Clinic Cancer Centers-Toledo Toledo Ohio
United States University of Kansas Health System Saint Francis Campus Topeka Kansas
United States Munson Medical Center Traverse City Michigan
United States Dayton Physicians LLC - Troy Troy Ohio
United States Upper Valley Medical Center Troy Ohio
United States Legacy Meridian Park Hospital Tualatin Oregon
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States MGC Hematology Oncology-Union Union South Carolina
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Legacy Cancer Institute Medical Oncology and Day Treatment Vancouver Washington
United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Essentia Health Virginia Clinic Virginia Minnesota
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Advanced Breast Care Center PLLC Warren Michigan
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Macomb Hematology Oncology PC Warren Michigan
United States Michigan Breast Specialists-Warren Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Saint Joseph Warren Hospital Warren Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States George Washington University Medical Center Washington District of Columbia
United States Illinois CancerCare - Washington Washington Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Mercy Hospital Washington Washington Missouri
United States ProHealth Waukesha Memorial Hospital Waukesha Wisconsin
United States UW Cancer Center at ProHealth Care Waukesha Wisconsin
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Froedtert West Bend Hospital/Kraemer Cancer Center West Bend Wisconsin
United States Henry Ford West Bloomfield Hospital West Bloomfield Michigan
United States Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan
United States University of Cincinnati Cancer Center-West Chester West Chester Ohio
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Saint Ann's Hospital Westerville Ohio
United States Marshfield Medical Center - Weston Weston Wisconsin
United States University of Kansas Hospital-Westwood Cancer Center Westwood Kansas
United States SCL Health Lutheran Medical Center Wheat Ridge Colorado
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Novant Health Cancer Institute - Wilkesboro Wilkesboro North Carolina
United States Wake Forest Baptist Health - Wilkes Medical Center Wilkesboro North Carolina
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
United States Novant Health Forsyth Medical Center Winston-Salem North Carolina
United States Wake Forest University Health Sciences Winston-Salem North Carolina
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Sanford Cancer Center Worthington Worthington Minnesota
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Fairview Lakes Medical Center Wyoming Minnesota
United States University of Michigan Health - West Wyoming Michigan
United States North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima Washington
United States Providence Regional Cancer System-Yelm Yelm Washington
United States Rush-Copley Healthcare Center Yorkville Illinois
United States Saint Elizabeth Youngstown Hospital Youngstown Ohio
United States Huron Gastroenterology PC Ypsilanti Michigan
United States Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan
United States Genesis Healthcare System Cancer Care Center Zanesville Ohio

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Other Estimates of OS by sex Estimates of OS and the corresponding 95% confidence intervals (CIs) by sex will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data). From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Other Estimates of OS by race Estimates of OS and the corresponding 95% CIs by race will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data). From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Other Estimates of OS by ethnicity Estimates of OS and the corresponding 95% CIs by ethnicity will be provided (with an understanding that sometimes the CI or estimate will not be computable because of scant data). From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Primary Overall survival (OS) OS of patients who achieve complete response (CR) and progressive disease (PD) from ipilimumab-nivolumab induction phase will be summarized. The stratified log-rank statistic will be the primary analysis to compare the hypothesis on OS with the stratification factors (presence of bone metastases and IMDC risk criteria). The Kaplan-Meier product-limit estimator will be used to estimate the OS. A stratified proportional hazards model will be used to generate estimates for the OS hazard ratio. For the randomized patients, OS will be calculated and compared from the time of randomization until the time of an OS event or time of last-follow-up, whatever occurs first. For the patients who were initially CR or PD, OS will be measured from the time of study registration. A comparison of OS will be made across the patient groups (randomized patients, patients initially CR, and patients initially PD). From registration to date of death from any cause for non-randomized patients, from time of randomization until death from any cause for randomized patients, assessed up to 5 years
Secondary Progression-free survival (PFS) Progression will be defined using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. PFS of patients who achieve CR and PD from ipilimumab-nivolumab induction phase will be summarized (secondary analysis). The Kaplan-Meier product-limit estimator will be used to estimate the PFS distribution. A stratified proportional hazards model will be used to generate estimates for the PFS hazard ratio. For the randomized patients, PFS will be calculated and compared from the time of randomization until the time of a PFS event or time of last-follow-up, whatever occurs first. For the patients who were initially CR or PD, PFS will be measured from the time of study registration. A comparison of PFS will be made across the patient groups (randomized patients, patients initially CR, and patients initially PD). For this comparison, PFS will be measured from time of study registration all the patients, regardless of whether they were randomized or not. From date of registration to date of progression (or disease recurrence) or death due to any cause, whichever occurs first, assessed up to 5 years
Secondary Complete response (CR) (randomized patients) Patients who had a CR prior to 12 months but have experienced a disease recurrence prior to 12 months, will not be considered to be a CR at 12 months. The Cochran-Mantel-Haenszel test will be used to compare the two arms on the proportion of patients who have a 12-month CR adjusting on the stratification factors. At 12 months from date of randomization
Secondary Objective response Defined as the best response observed that has been confirmed by a scan performed 4 or more weeks after the observation of the initial response. The objective response will be confirmed using RECIST 1.1. In addition, objective responses will also be confirmed using Immune Response Evaluation Criteria in Solid Tumors (iRECIST). Up to 5 years
Secondary Proportion of patients who discontinue protocol-directed treatment prior to 1 year from date of study registration Patients who stop their protocol directed treatment for any reason prior to one year from study registration will be considered to have discontinued their treatment. The Cochran-Mantel-Haenszel test will also be used to compare the proportion of patients who discontinue their treatment prior to one-year after study registration. Up to 5 years
Secondary Incidence of adverse events Assessed with National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. A Fisher's exact test will be used to compare the two treatment arms on the proportion of patient with a grade 3 or higher adverse event. Up to 5 years
See also
  Status Clinical Trial Phase
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