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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02506153
Other study ID # NCI-2014-02676
Secondary ID NCI-2014-02676S1
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 10, 2015
Est. completion date January 23, 2025

Study information

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

Clinical Trial Summary

This randomized phase III trial studies how well pembrolizumab works compared with the current standard of care, physician/patient choice of either high-dose recombinant interferon alfa-2B or ipilimumab, in treating patients with stage III-IV melanoma that has been removed by surgery but is likely to come back or spread. High-dose recombinant interferon alfa-2B may help shrink or slow the growth of melanoma. Immunotherapy with monoclonal antibodies, such as ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether pembrolizumab is more effective than the current standard of care in treating patients with melanoma.


Description:

PRIMARY OBJECTIVES: I. To compare overall survival (OS) of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon recombinant interferon alfa-2b (alfa-2b) or ipilimumab versus MK-3475 (pembrolizumab). II. Among patients who are PD-L1 positive, to compare OS of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab versus MK-3475 (pembrolizumab). III. To compare relapse-free survival (RFS) of patients with resected stage III and IV melanoma treated with physician/patient choice of either high dose interferon alfa-2b or ipilimumab to MK-3475 (pembrolizumab). SECONDARY OBJECTIVES: I. To estimate OS and RFS for patients who are PD-L1 negative or PD-L1 indeterminate in this population. II. To compare OS and RFS of patients between the two arms within PD-L1 positive and negative subgroups and to look at the interaction between PD-L1 (positive versus negative) and treatment arm. III. To assess the safety and tolerability of the regimens. ADDITIONAL OBJECTIVES: I. To bank tissue and whole blood in anticipation of future correlative studies in this patient population. II. To evaluate PD-L1 expression through immunohistochemistry assay. III. To evaluate the effect of treatment-related side effects that may have an impact on the health-related domains of quality of life (QOL) using the Functional Assessment of Cancer Therapy (FACT)-Biological Response Modifiers (BRM), European Quality of Life Five Dimension Three Level Scale (EQ-5D-3L), and Functional Assessment of Chronic Illness Therapy Diarrhea (FACIT-D) between patients treated with physician/patient choice of either high-dose interferon alfa-2b or ipilimumab and MK-3475 (pembrolizumab). IV. Pharmacokinetic (PK) and anti-drug antibody (ADA) testing will be performed on all patients receiving MK-3475 (pembrolizumab). TRANSLATIONAL OBJECTIVES RELATED TO T-CELL RECEPTOR BETA CHAIN SEQUENCING: I. To evaluate the association between TCR beta variable gene (TRBV) haplotype and grade 3-4 immune-related adverse events (irAEs) among stage III melanoma patients treated with adjuvant ipilimumab or pembrolizumab. II. To describe the TRBV haplotype distribution among this cohort of patients studied. TRANSLATIONAL MEDICINAL OBJECTIVE RELATED TO ASSOCIATION OF CIRCULATING TUMOR DNA (ctDNA) WITH RELAPSE-FREE SURVIVAL IN HIGH-RISK, RESECTED MELANOMA PATIENTS. I. To evaluate associations between pretreatment ctDNA (present versus absent) and relapse within 2 years of randomization in a case-control analysis across treatment arms. II. To evaluate associations between pretreatment ctDNA (present versus absent) and relapse within 2 years of randomization in a case-control analysis across treatment arms. III. To evaluate associations between pretreatment ctDNA and relapse within 2 years of randomization in a case-control analysis within each treatment arm (after treatment arm data are unblinded to investigators). IV. To evaluate associations between "early-on treatment" ctDNA levels and relapse within 2 years of randomization. V. To describe ctDNA levels at end of therapy and time of relapse. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: INDUCTION THERAPY: Patients receive high-dose recombinant interferon alfa-2B intravenously (IV) over 20 minutes on days 1-5. Treatment repeats weekly for 4 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 3 weeks for a total of 4 cycles in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Patients receive high-dose recombinant interferon alfa-2B subcutaneously (SC) on days 1, 3, and 5. Treatment repeats every 6 weeks for up to 48 weeks in the absence of disease progression or unacceptable toxicity. Or patients receive ipilimumab IV over 90 minutes on day 1. Treatment repeats every 12 weeks for 3 years in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan, positron emission tomography (PET) scan, magnetic resonance imaging (MRI) and blood sample collection throughout the study. After completion of study treatment, patients are followed up at 30 days, 6 and 12 weeks, every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1345
Est. completion date January 23, 2025
Est. primary completion date September 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - STEP 1 REGISTRATION: - Patients must have completely resected melanoma of cutaneous origin or of unknown primary in order to be eligible for this study; patients must be classified as stage IIIA (N2a), IIIB, IIIC, or stage IV melanoma; patients with non-ulcerated T1b N1a disease are not eligible; patients with melanoma of mucosal or other non-cutaneous origin are eligible; patients with melanoma of ocular origin are not eligible; patients with a history of brain metastases are ineligible - Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site; nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin and eosin (H & E) stained slides - Patients with multiple regional nodal basin involvement are eligible; gross or microscopic extracapsular nodal extension is permitted - Patients at initial presentation of melanoma must undergo an adequate wide excision of the primary lesion, if present; patients with previously diagnosed melanoma must have had all current disease resected with pathologically negative margins and must have no evidence of disease at the primary site or must undergo re-resection of the primary site; a full lymphadenectomy meeting the criteria outlined is required for all node-positive patients including those with positive sentinel nodes; patients with recurrent disease who have had a prior complete lymphadenectomy fulfill this requirement as long as all recurrent disease has been resected; for all patients, all disease must have been resected with negative pathological margins and no clinical, radiologic, or pathological evidence of any incompletely resected melanoma; patients must be registered within 98 days of the last surgery performed to render the patient free of disease - Patients must have available and be willing to submit a minimum of five unstained slides from primary, lymph node, or metastatic site to determine PD-L1 expression; the tumor tissue must be adequate for PD-L1 testing (defined as >= 100 tumor cells as confirmed by the treating institution's local pathologist); this must be documented by having a pathologist sign the S1404 Local Pathology Review form prior to step 1 registration; the specimens may come from an archived block but must be submitted within 20 days from cutting the slides - Patients must be offered the opportunity to participate in specimen banking as outlined - Patients must be willing to have blood draws for PK/ADA analysis as outlined, should the patient be randomized to the MK-3475 arm - Patients may have received prior radiation therapy, including after the surgical resection; all adverse events associated with prior surgery and radiation therapy must have resolved to =< grade 1 prior to registration - Patients must not have received neoadjuvant treatment for their melanoma; patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose IL-2, pegylated (PEG)-IFN, anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies; patients must not be planning to receive any of the prohibited therapies during the screening or treatment phases of the study - Patients must not be planning to receive concomitant other biologic therapy, radiation therapy, hormonal therapy, other chemotherapy, surgery or other therapy after step 2 registration - All patients must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to registration; imaging studies must include a total body positron emission tomography (PET)-computed tomography (CT) scan that is of diagnostic quality (with or without brain) or a CT of the chest, abdomen and pelvis; for patients with melanoma arising from the head and neck, dedicated neck imaging (CT with IV contrast or PET-CT through the region) is required; if the patient has had unknown primary with disease in the axilla, neck imaging is required to assure region is clear of cancer; CT imaging should be done with intravenous contrast if there are no contraindications for it; any other clinically-indicated imaging studies if performed (e.g. bone scan) must show no evidence of disease - All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 90 days prior to registration; the brain CT or MRI should be performed with intravenous contrast (unless contraindicated) - Absolute neutrophil count (ANC) >= 1,500 microliter (mcL) (within 42 days prior to registration) - Platelets >= 100,000 mcL (within 42 days prior to registration) - Hemoglobin >= 10 g/dL (within 42 days prior to registration) - Total bilirubin =< 1.5 x institutional upper limit of normal (IULN) (except Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 42 days prior to registration) - Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2 x IULN (within 42 days prior to registration) - Alkaline phosphatase =< 2 x IULN (within 42 days prior to registration) - Serum creatinine =< IULN OR measured or calculated creatinine clearance >= 60 mL/min (within 42 days prior to registration) - Patients must have lactate dehydrogenase (LDH) performed within 42 days prior to registration - Patients must have Zubrod performance status =< 1 - Patients must have a baseline electrocardiogram (ECG) performed within 42 days of registration that is normal or considered not clinically significant by the site investigator - Patients must not have a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Patients must not have an active infection requiring systemic therapy - Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment - Patients must not have received live vaccines within 42 days prior to registration; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed - Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 30 days prior to registration: stable and adequate cluster of differentiation 4 (CD4) counts (>= 350 mm^3), and serum HIV viral load of < 25,000 IU/ml; patients may be on or off anti-viral therapy so long as they meet the CD4 count criteria - Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection prior to registration - Patients must not have a history or current evidence of any condition, therapy or laboratory abnormality that might confound the trial results, interfere with the patient's participation for the full duration of the trial, or indicate that participation in the trial is not in the patient's best interests, in the opinion of the treating investigator - No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma of the breast in situ, atypical melanocytic hyperplasia or melanoma in situ, adequately treated stage I or II cancer (including multiple primary melanomas) from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years - Women of childbearing potential must have a negative urine or serum pregnancy test within 28 days prior to registration; women/men of reproductive potential must have agreed to use an effective contraceptive method for the course of the study through 120 days after the last dose of study medication; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures, he/she is responsible for beginning contraceptive measures; patients must not be pregnant or nursing due to unknown teratogenic side effects - Patients who are able to complete questionnaires in English, Spanish or French must participate in the quality of life assessments; (those patients who cannot complete the quality of life questionnaires in English, Spanish or French can be registered to S1404 without contributing to the quality of life studies) - Patients must be informed of the investigational nature of this study and must sign and give written informed consent for this protocol in accordance with institutional and federal guidelines - As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system - STEP 2 REGISTRATION (RANDOMIZATION CRITERIA): - Patients must not be registered until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L1 testing; patients must be registered within 7 working days of receiving the e-mail notification - Women of childbearing potential must plan to have a urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required - No tests or exams are required to be repeated for step 2 registration (randomization); however, patients who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration; for example, ANC is not required to be repeated between step 1 and step 2 registration, but the most recent ANC performed before step 2 registration is required to be >= 1,500 mcL

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Biological:
Ipilimumab
Given IV
Procedure:
Magnetic Resonance Imaging
Undergo MRI
Biological:
Pembrolizumab
Given IV
Procedure:
Positron Emission Tomography
Undergo PET scan
Other:
Quality-of-Life Assessment
Ancillary studies
Biological:
Recombinant Interferon Alfa-2b
Given IV and SC

Locations

Country Name City State
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada Kingston Health Sciences Centre Kingston Ontario
Canada Grand River Regional Cancer Centre at Grand River Hospital Kitchener Ontario
Canada Hopital de la Cite-de-la-Sante Laval Quebec
Canada London Regional Cancer Program London Ontario
Canada Trillium Health Partners - Credit Valley Hospital Mississauga Ontario
Canada The Vitalite Health Network - Dr Leon Richard Oncology Centre Moncton New Brunswick
Canada The Research Institute of the McGill University Health Centre (MUHC) Montreal Quebec
Canada Lakeridge Health Oshawa Oshawa Ontario
Canada Ottawa Hospital and Cancer Center-General Campus Ottawa Ontario
Canada CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ) Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Algoma District Cancer Program Sault Area Hospital Sault Ste Marie Ontario
Canada Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke Quebec
Canada Thunder Bay Regional Health Science Centre Thunder Bay Ontario
Canada Odette Cancer Centre- Sunnybrook Health Sciences Centre Toronto Ontario
Canada University Health Network-Princess Margaret Hospital Toronto Ontario
Canada BCCA-Vancouver Cancer Centre Vancouver British Columbia
Canada Windsor Regional Cancer Centre Windsor Ontario
Ireland Saint Vincent's University Hospital Dublin Co Dublin
Ireland University College Hospital Galway Galway Co Galway
Ireland University Hospital Waterford Waterford Co Waterford
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Jefferson Abington Hospital Abington Pennsylvania
United States Lovelace Medical Center-Saint Joseph Square Albuquerque New Mexico
United States Southwest Gynecologic Oncology Associates Inc Albuquerque New Mexico
United States University of New Mexico Cancer Center Albuquerque New Mexico
United States Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania
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 AnMed Health Cancer Center Anderson South Carolina
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Langlade Hospital and Cancer Center Antigo Wisconsin
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Northside Hospital Atlanta Georgia
United States Hematology Oncology Associates of Central New York-Auburn Auburn New York
United States Sutter Auburn Faith Hospital Auburn California
United States Harold Alfond Center for Cancer Care Augusta Maine
United States Rush - Copley Medical Center Aurora Illinois
United States UCHealth University of Colorado Hospital Aurora Colorado
United States Texas Oncology - Central Austin Cancer Center Austin Texas
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States Mercy Medical Center Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Flaget Memorial Hospital Bardstown Kentucky
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 Our Lady of the Lake Physician Group Baton Rouge Louisiana
United States UHHS-Chagrin Highlands Medical Center Beachwood Ohio
United States Kaiser Permanente-Bellflower Bellflower California
United States Strecker Cancer Center-Belpre Belpre Ohio
United States Sanford Joe Lueken Cancer Center Bemidji Minnesota
United States Central Vermont Medical Center/National Life Cancer Treatment Berlin Vermont
United States Saint Luke's University Hospital-Bethlehem Campus Bethlehem Pennsylvania
United States Beverly Hospital Beverly Massachusetts
United States Billings Clinic Cancer Center Billings Montana
United States Saint Vincent Healthcare Billings Montana
United States University of Alabama at Birmingham Cancer Center Birmingham Alabama
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States Saint Luke's Cancer Institute - Boise Boise Idaho
United States Parkland Health Center-Bonne Terre Bonne Terre Missouri
United States McFarland Clinic - Boone Boone Iowa
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States Lafayette Family Cancer Center-EMMC Brewer Maine
United States United Hospital Center Bridgeport West Virginia
United States Roswell Park Cancer Institute Buffalo New York
United States Aurora Cancer Care-Southern Lakes VLCC Burlington Wisconsin
United States Lahey Hospital and Medical Center Burlington Massachusetts
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 Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Illinois CancerCare-Canton Canton Illinois
United States Saint Francis Medical Center Cape Girardeau Missouri
United States Southeast Cancer Center Cape Girardeau Missouri
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Physicians' Clinic of Iowa PC Cedar Rapids Iowa
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 Cancer Center of Kansas - Chanute Chanute Kansas
United States UNC Lineberger Comprehensive Cancer Center Chapel Hill North Carolina
United States Bon Secours Saint Francis Hospital Charleston South Carolina
United States Charleston Oncology - Roper Charleston South Carolina
United States Charleston Oncology - Saint Francis Charleston South Carolina
United States Lowcountry Hematology Oncology PA-North Charleston Charleston South Carolina
United States Lowcountry Hematology Oncology PA-West Ashley Charleston South Carolina
United States Roper Hospital Charleston South Carolina
United States West Virginia University Charleston Division Charleston West Virginia
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 Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
United States University of Cincinnati Cancer Center-UC Medical Center Cincinnati Ohio
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Southeastern Medical Oncology Center-Clinton Clinton North Carolina
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Mission Cancer and Blood - West Des Moines Clive Iowa
United States Big Horn Basin Cancer Center Cody Wyoming
United States Billings Clinic-Cody Cody Wyoming
United States Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States UCHealth Memorial Hospital Central Colorado Springs Colorado
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 Mercy Hospital Coon Rapids Minnesota
United States UC Irvine Health Cancer Center-Newport Costa Mesa California
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Northside Hospital-Forsyth Cumming Georgia
United States Baylor University Medical Center 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 Cancer Care Specialists of Illinois - Decatur Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Grady Memorial Hospital Delaware Ohio
United States Kaiser Permanente-Franklin Denver Colorado
United States Porter Adventist Hospital Denver Colorado
United States SCL Health Saint Joseph Hospital Denver Colorado
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 Wayne State University/Karmanos Cancer Institute Detroit Michigan
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Wentworth-Douglass Hospital Dover New Hampshire
United States City of Hope Comprehensive Cancer Center Duarte California
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 Duke University Medical Center Durham North Carolina
United States Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan
United States Veterans Adminstration New Jersey Health Care System East Orange New Jersey
United States Hematology Oncology Associates of Central New York-East Syracuse East Syracuse New York
United States Marshfield Clinic Cancer Center at Sacred Heart Eau Claire Wisconsin
United States Fairview Southdale Hospital Edina Minnesota
United States Carle Physician Group-Effingham Effingham Illinois
United States Crossroads Cancer Center Effingham Illinois
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Elmhurst Memorial Hospital Elmhurst Illinois
United States Ephrata Cancer Center Ephrata Pennsylvania
United States Ephrata Community Hospital Ephrata Pennsylvania
United States UPMC Hillman Cancer Center Erie Erie Pennsylvania
United States OSF Saint Francis Hospital and Medical Group Escanaba Michigan
United States Illinois CancerCare-Eureka Eureka Illinois
United States NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States Sanford Broadway Medical Center Fargo North Dakota
United States Sanford Clinic North-Fargo Fargo North Dakota
United States Sanford Roger Maris Cancer Center Fargo North Dakota
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 Genesys Hurley Cancer Institute Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Aurora Health Center-Fond du Lac Fond Du Lac Wisconsin
United States Saint Agnes Hospital/Agnesian Cancer Center Fond Du Lac Wisconsin
United States Kaiser Permanente-Fontana Fontana California
United States Poudre Valley Hospital Fort Collins Colorado
United States McFarland Clinic - Trinity Cancer Center Fort Dodge Iowa
United States Frederick Memorial Hospital Frederick Maryland
United States Kaiser Permanente-Fremont Fremont California
United States Palo Alto Medical Foundation-Fremont Fremont California
United States Kaiser Permanente-Fresno Fresno California
United States Unity Hospital Fridley Minnesota
United States Saint Luke's Cancer Institute - Fruitland Fruitland Idaho
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Saint Catherine Hospital Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States The West Clinic - Wolf River Germantown Tennessee
United States Adams Cancer Center Gettysburg Pennsylvania
United States Glens Falls Hospital Glens Falls New York
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States Addison Gilbert Hospital Gloucester Massachusetts
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Altru Cancer Center Grand Forks North Dakota
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Corewell Health Grand Rapids Hospitals - Butterworth 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 Saint Rose Ambulatory and Surgery Center 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 Aurora BayCare Medical Center Green Bay Wisconsin
United States Green Bay Oncology at Saint Vincent Hospital Green Bay Wisconsin
United States Green Bay Oncology Limited at Saint Mary's 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 Saint Francis Cancer Center Greenville South Carolina
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 Hackensack University Medical Center Hackensack New Jersey
United States WellSpan Medical Oncology and Hematology Hanover Pennsylvania
United States Kaiser Permanente - Harbor City Harbor City California
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States HaysMed Hays Kansas
United States Geisinger Medical Center-Cancer Center 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-Southeast Henderson Henderson Nevada
United States GenesisCare USA - Henderson Henderson Nevada
United States Las Vegas Cancer Center-Henderson Henderson Nevada
United States Hendersonville Hematology and Oncology at Pardee 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 NorthShore University HealthSystem-Highland Park Hospital Highland Park Illinois
United States Hawaii Cancer Care Inc - Waterfront Plaza Honolulu Hawaii
United States Hawaii Cancer Care Inc-Liliha Honolulu Hawaii
United States Island Urology 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 Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
United States M D Anderson Cancer Center Houston Texas
United States Centerpoint Medical Center LLC Independence Missouri
United States Cleveland Clinic Cancer Center Independence Independence Ohio
United States Community Cancer Center East Indianapolis Indiana
United States Community Cancer Center North Indianapolis Indiana
United States Community Cancer Center South Indianapolis Indiana
United States Franciscan Health Indianapolis Indianapolis Indiana
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Green Bay Oncology - Iron Mountain Iron Mountain Michigan
United States Kaiser Permanente-Irvine Irvine California
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 McFarland Clinic - Jefferson Jefferson Iowa
United States MU Health Care Goldschmidt Cancer Center Jefferson City Missouri
United States West Michigan Cancer Center Kalamazoo Michigan
United States Kalispell Regional Medical Center Kalispell Montana
United States Heartland Hematology and Oncology Associates Incorporated Kansas City Missouri
United States Kansas City Veterans Affairs Medical Center Kansas City Missouri
United States Research Medical Center Kansas City Missouri
United States Saint Luke's Hospital of Kansas City Kansas City Missouri
United States The University of Kansas Cancer Center-South Kansas City Missouri
United States University Health Truman Medical Center Kansas City Missouri
United States University of Kansas Cancer Center Kansas City Kansas
United States University of Kansas Cancer Center - North Kansas City Missouri
United States University of Kansas Cancer Center-West Kansas City Kansas
United States Aurora Cancer Care-Kenosha South Kenosha Wisconsin
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 Gundersen Lutheran Medical Center La Crosse Wisconsin
United States UC San Diego Moores Cancer Center La Jolla California
United States Providence Regional Cancer System-Lacey Lacey Washington
United States Kaiser Permanente-Rock Creek Lafayette Colorado
United States Lakeland Regional Health Hollis Cancer Center Lakeland Florida
United States University of Michigan Health - Sparrow Lansing Lansing Michigan
United States Ann M Wierman MD LTD Las Vegas Nevada
United States Cancer Therapy and Integrative Medicine 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 GenesisCare USA - Las Vegas Las Vegas Nevada
United States Las Vegas Cancer Center-Medical Center Las Vegas Nevada
United States OptumCare Cancer Care at Fort Apache Las Vegas Nevada
United States University Cancer Center Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon New Hampshire
United States Saint Luke's East - Lee's Summit Lee's Summit Missouri
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 Saint Joseph Hospital East Lexington Kentucky
United States Saint Joseph Radiation Oncology Resource Center Lexington Kentucky
United States Cancer Center of Kansas-Liberal Liberal Kansas
United States Liberty Radiation Oncology Center Liberty Missouri
United States Cancer Partners of Nebraska Lincoln Nebraska
United States Nebraska Hematology and Oncology Lincoln Nebraska
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Littleton Adventist Hospital Littleton Colorado
United States Saint Barnabas Medical Center Livingston New Jersey
United States Logan Regional Hospital Logan Utah
United States Kaiser Permanente-Lone Tree Lone Tree Colorado
United States PeaceHealth Saint John Medical Center Longview Washington
United States Cedars Sinai Medical Center Los Angeles California
United States Kaiser Permanente Los Angeles Medical Center Los Angeles California
United States Kaiser Permanente West Los Angeles Los Angeles California
United States Los Angeles General Medical Center Los Angeles California
United States UCLA / Jonsson Comprehensive Cancer Center Los Angeles California
United States USC / Norris Comprehensive Cancer Center Los Angeles California
United States Saints Mary and Elizabeth Hospital Louisville Kentucky
United States UofL Health Medical Center Northeast Louisville Kentucky
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 University of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin
United States Dartmouth Cancer Center - Manchester Manchester New Hampshire
United States Cleveland Clinic Cancer Center Mansfield Mansfield Ohio
United States OhioHealth Mansfield Hospital Mansfield Ohio
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 Aurora Bay Area Medical Group-Marinette Marinette Wisconsin
United States Bay Area Medical Center Marinette Wisconsin
United States OhioHealth Marion General Hospital Marion Ohio
United States McFarland Clinic - Marshalltown Marshalltown Iowa
United States Marshfield Medical Center-Marshfield Marshfield Wisconsin
United States Fremont - Rideout Cancer Center Marysville California
United States Carle Physician Group-Mattoon/Charleston Mattoon Illinois
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Loyola University Medical Center Maywood Illinois
United States Cancer Center of Kansas - McPherson McPherson Kansas
United States The West Clinic - Mid-Town Memphis Tennessee
United States University of Tennessee Health Science Center Memphis Tennessee
United States Froedtert Menomonee Falls Hospital Menomonee Falls Wisconsin
United States Saint Luke's Cancer Institute - Meridian Meridian Idaho
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Ascension Southeast Wisconsin Hospital - Saint Joseph Campus Milwaukee Wisconsin
United States Aurora Cancer Care-Milwaukee Milwaukee Wisconsin
United States Aurora Saint Luke's Medical Center Milwaukee Wisconsin
United States Aurora Sinai Medical Center Milwaukee Wisconsin
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Abbott-Northwestern Hospital Minneapolis Minnesota
United States Hennepin County Medical Center Minneapolis Minnesota
United States Marshfield Clinic-Minocqua Center Minocqua Wisconsin
United States Community Medical Center Missoula Montana
United States Saint Patrick Hospital - Community Hospital Missoula Montana
United States Kaiser Permanente-Modesto Modesto California
United States Memorial Medical Center Modesto California
United States Ochsner LSU Health Monroe Medical Center Monroe Louisiana
United States Franciscan Health Mooresville Mooresville Indiana
United States West Virginia University Healthcare Morgantown West Virginia
United States Lowcountry Hematology Oncology PA-Mount Pleasant Mount Pleasant South Carolina
United States Knox Community Hospital Mount Vernon Ohio
United States Palo Alto Medical Foundation-Camino Division Mountain View California
United States Intermountain Medical Center Murray Utah
United States Trinity Health Muskegon Hospital Muskegon Michigan
United States Saint Luke's Cancer Institute - Nampa Nampa Idaho
United States Edward Hospital/Cancer Center Naperville Illinois
United States Dartmouth Cancer Center - Nashua Nashua New Hampshire
United States Saint Joseph Hospital Nashua New Hampshire
United States Vanderbilt University/Ingram Cancer Center Nashville Tennessee
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Yale University New Haven Connecticut
United States UC Comprehensive Cancer Center at Silver Cross New Lenox Illinois
United States Cancer Center of Western Wisconsin New Richmond Wisconsin
United States NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York New York
United States Christiana Care Health System-Christiana Hospital 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 Newport Hospital Newport Rhode Island
United States USC Norris Oncology/Hematology-Newport Beach Newport Beach California
United States Cancer Center of Kansas - Newton Newton Kansas
United States Faith Regional Health Services Carson Cancer Center Norfolk Nebraska
United States Sutter Cancer Research Consortium Novato California
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Kaiser Permanente-Oakland Oakland California
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 - Omaha Omaha Nebraska
United States Nebraska Methodist Hospital Omaha Nebraska
United States Saint Joseph Hospital - Orange Orange California
United States UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
United States University of Chicago Medicine-Orland Park Orland Park Illinois
United States Orlando Health Cancer Institute Orlando Florida
United States Vince Lombardi Cancer Clinic - Oshkosh Oshkosh Wisconsin
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Menorah Medical Center Overland Park Kansas
United States Saint Luke's South Hospital Overland Park Kansas
United States University of Kansas Cancer Center-Overland Park Overland Park Kansas
United States Owensboro Health Mitchell Memorial Cancer Center Owensboro Kentucky
United States Palo Alto Medical Foundation Health Care Palo Alto California
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
United States Parker Adventist Hospital Parker Colorado
United States Camden Clark Medical Center Parkersburg West Virginia
United States University Hospitals Parma Medical Center Parma Ohio
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 Illinois CancerCare-Peru Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Cancer Center at Saint Joseph's Phoenix Arizona
United States Ascension Via Christi - Pittsburg Pittsburg Kansas
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States West Penn Hospital Pittsburgh Pennsylvania
United States Edward Hospital/Cancer Center?Plainfield Plainfield Illinois
United States Kaiser Permanente Northwest Portland Oregon
United States Oregon Health and Science University Portland Oregon
United States Providence Portland Medical Center Portland Oregon
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 Illinois CancerCare-Princeton Princeton Illinois
United States Miriam Hospital Providence Rhode Island
United States Rhode Island Hospital Providence Rhode Island
United States Utah Valley Regional Medical Center Provo Utah
United States Aurora Cancer Care-Racine Racine Wisconsin
United States Rapid City Regional Hospital Rapid City South Dakota
United States Kaiser Permanente-Redwood City Redwood City California
United States Corewell Health Reed City Hospital Reed City Michigan
United States Beebe Health Campus Rehoboth Beach Delaware
United States Lakeview Medical Center-Marshfield Clinic Rice Lake Wisconsin
United States Marshfield Medical Center-Rice Lake Rice Lake Wisconsin
United States Kaiser Permanente-Richmond Richmond California
United States Reid Health Richmond Indiana
United States Virginia Cancer Institute Richmond Virginia
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Kaiser Permanente-Riverside Riverside California
United States Rochester General Hospital Rochester New York
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 Highlands Oncology Group - Rogers Rogers Arkansas
United States Kaiser Permanente-Roseville Roseville California
United States Sutter Roseville Medical Center Roseville California
United States Kaiser Permanente - Sacramento Sacramento California
United States Kaiser Permanente-South Sacramento Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States University of California Davis Comprehensive Cancer Center Sacramento California
United States Ascension Saint Mary's Hospital Saginaw Michigan
United States Saint George Regional Medical Center Saint George Utah
United States Heartland Regional Medical Center Saint Joseph Missouri
United States Missouri Baptist Medical Center 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 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri
United States Cancer Center of Kansas - Salina Salina Kansas
United States Salina Regional Health Center Salina Kansas
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
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 California Pacific Medical Center-Pacific Campus San Francisco California
United States Kaiser Permanente-San Francisco San Francisco California
United States Kaiser Permanente-Santa Teresa-San Jose San Jose California
United States Kaiser Permanente San Leandro San Leandro California
United States Kaiser Permanente-San Marcos San Marcos California
United States Kaiser Permanente-San Rafael San Rafael California
United States Kootenai Cancer Clinic Sandpoint Idaho
United States North Coast Cancer Care Sandusky Ohio
United States UH Seidman Cancer Center at Firelands Regional Medical Center Sandusky Ohio
United States Kaiser Permanente Medical Center - Santa Clara Santa Clara California
United States Palo Alto Medical Foundation-Santa Cruz Santa Cruz California
United States Kaiser Permanente-Santa Rosa Santa Rosa California
United States Sutter Pacific Medical Foundation Santa Rosa California
United States Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
United States Maine Center for Cancer Medicine-Scarborough Scarborough Maine
United States Regional West Medical Center Cancer Center Scottsbluff Nebraska
United States Virginia G Piper Cancer Care-Del Camino Scottsdale Arizona
United States Kaiser Permanente Washington Seattle Washington
United States Swedish Medical Center-First Hill Seattle Washington
United States HSHS Saint Nicholas Hospital Sheboygan Wisconsin
United States Vince Lombardi Cancer Clinic-Sheboygan Sheboygan Wisconsin
United States Providence Regional Cancer System-Shelton Shelton Washington
United States Welch Cancer Center Sheridan Wyoming
United States LSU Health Sciences Center at Shreveport Shreveport Louisiana
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 VCU Community Memorial Health Center South Hill Virginia
United States South Jordan Health Center South Jordan Utah
United States Kaiser Permanente-South San Francisco South San Francisco California
United States Baystate Medical Center Springfield Massachusetts
United States Central Illinois Hematology Oncology Center Springfield Illinois
United States CoxHealth South Hospital Springfield Missouri
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Southern Illinois University School of Medicine Springfield Illinois
United States Springfield Clinic Springfield Illinois
United States Stamford Hospital/Bennett Cancer Center Stamford Connecticut
United States Ascension Saint Michael's Hospital Stevens Point Wisconsin
United States Kaiser Permanente-Stockton Stockton California
United States Stony Brook University Medical Center Stony Brook New York
United States Cleveland Clinic Cancer Center Strongsville Strongsville Ohio
United States Green Bay Oncology - Sturgeon Bay Sturgeon Bay Wisconsin
United States Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay Wisconsin
United States Missouri Baptist Sullivan Hospital Sullivan Missouri
United States Aurora Medical Center in Summit Summit Wisconsin
United States Palo Alto Medical Foundation-Sunnyvale Sunnyvale California
United States ProMedica Flower Hospital Sylvania Ohio
United States Hematology Oncology Associates of Central New York-Onondaga Hill Syracuse New York
United States State University of New York Upstate Medical University Syracuse New York
United States Moffitt Cancer Center Tampa Florida
United States University of 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 Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee California
United States Smilow Cancer Hospital Care Center-Trumbull Trumbull Connecticut
United States Banner University Medical Center - Tucson Tucson Arizona
United States University of Arizona Cancer Center-North Campus Tucson Arizona
United States Saint Luke's Cancer Institute - Twin Falls Twin Falls Idaho
United States Vince Lombardi Cancer Clinic-Two Rivers Two Rivers Wisconsin
United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Kaiser Permanente Medical Center-Vacaville Vacaville California
United States South Georgia Medical Center/Pearlman Cancer Center Valdosta Georgia
United States Kaiser Permanente-Vallejo Vallejo California
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
United States Kaiser Permanente-Walnut Creek Walnut Creek California
United States Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States South Pointe Hospital Warrensville Heights Ohio
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States MedStar Georgetown University Hospital Washington District of Columbia
United States MedStar Washington Hospital Center Washington District of Columbia
United States Aspirus Regional Cancer Center Wausau Wisconsin
United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Aurora West Allis Medical Center West Allis Wisconsin
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Saint Ann's Hospital Westerville Ohio
United States Cleveland Clinic-Weston Weston Florida
United States Marshfield Medical Center - Weston Weston Wisconsin
United States Wexford Health and Wellness Pavilion Wexford Pennsylvania
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 UPMC Susquehanna Williamsport Pennsylvania
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin
United States Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids Wisconsin
United States Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota
United States Kaiser Permanente-Woodland Hills Woodland Hills California
United States Cleveland Clinic Wooster Family Health and Surgery Center Wooster Ohio
United States University of Michigan Health - West Wyoming Michigan
United States Providence Regional Cancer System-Yelm Yelm Washington
United States WellSpan Health-York Cancer Center York Pennsylvania
United States WellSpan Health-York Hospital York Pennsylvania
United States Rush-Copley Healthcare Center Yorkville Illinois
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,  Canada,  Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival (OS) From date of randomization to date of death due to any cause. Patients last known to be alive were censored at date of last contact. OS estimates will be calculated using the method of Kaplan-Meier. Comparison between arms will be performed using a stratified log-rank test in the intent-to-treat population. Up to 10 years from date of randomization
Primary Relapse-free survival (RFS) From date of randomization to date of first documentation of disease recurrence (relapse) or death due to any cause. On study disease assessments by imaging were to be performed every 12 weeks until 2 years from randomization, and then every 6 months until 5 years from randomization. Patients last known to be alive and relapse-free were censored at date of last contact. RFS estimates will be calculated using the method of Kaplan-Meier. Comparison between arms will be performed using a stratified log-rank test in the intent-to-treat population. Up to 5 years from date of randomization
Primary Overall Survival among patients with PD-L1 positive tumors From date of randomization to date of death due to any cause. Patients last known to be alive were censored at date of last contact. OS estimates will be calculated using the method of Kaplan-Meier. Comparison between arms will be performed using a stratified log-rank test in the intent-to-treat population among those patients with PD-L1 positive tumors.
PD-L1 expression was evaluated by immunohistochemistry (IHC) assay on archival or fresh tumor tissue using the 22C3 antibody and was scored on a scale of 0 to 5 (with higher numbers reflecting a higher level of PD-L1 expression); a score of 2 or higher (staining on greater than 1% of cells) was considered to indicate PD-L1 positivity.
Up to 10 years from randomization
Secondary Relapse-free survival among patients with PD-L1 positive tumors From date of randomization to date of first documentation of disease recurrence (relapse) or death due to any cause. On study disease assessments by imaging were to be performed every 12 weeks until 2 years from randomization, and then every 6 months until 5 years from randomization. Patients last known to be alive and relapse-free were censored at date of last contact. RFS estimates will be calculated using the method of Kaplan-Meier. Comparison between arms will be performed using a stratified log-rank test in the intent-to-treat population among those patients with PD-L1 positive tumors.
PD-L1 expression was evaluated by immunohistochemistry (IHC) assay on archival or fresh tumor tissue using the 22C3 antibody and was scored on a scale of 0 to 5 (with higher numbers reflecting a higher level of PD-L1 expression); a score of 2 or higher (staining on greater than 1% of cells) was considered to indicate PD-L1 positivity.
Up to 5 years from the date of randomization
Secondary Overall Survival among patients with PD-L1 negative tumors From date of randomization to date of death due to any cause. Patients last known to be alive will be censored at date of last contact. OS estimates will be calculated using the method of Kaplan-Meier. Cox regression models will be used to estimate hazard ratios and calculate confidence intervals to compare treatment arms in the PD-L1 negative subgroup. In addition Cox regression models for OS will be used to estimate interaction terms between PD-L1 status and treatment arm.
PD-L1 expression was evaluated by immunohistochemistry (IHC) assay on archival or fresh tumor tissue using the 22C3 antibody and was scored on a scale of 0 to 5 (with higher numbers reflecting a higher level of PD-L1 expression); a score of 0-1 (staining on = 1% of cells) was considered to indicate PD-L1 negative status.
Up to 10 years from date of randomization
Secondary RFS among patients with PD-L1 negative tumors From date of randomization to date of first documentation of disease recurrence (relapse) or death due to any cause. On study disease assessments by imaging were to be performed every 12 weeks until 2 years from randomization, and then every 6 months until 5 years from randomization. Patients last known to be alive and relapse-free were censored at date of last contact. RFS estimates will be calculated using the method of Kaplan-Meier. Cox regression models will be used to estimate hazard ratios and calculate confidence intervals to compare treatment arms in the PD-L1 negative subgroup. In addition Cox regression models for RFS will be used to estimate interaction terms between PD-L1 status and treatment arm.
PD-L1 expression was evaluated by IHC assay on archival or fresh tumor tissue using the 22C3 antibody and was scored on a scale of 0 to 5; a score of 2 or higher was considered to indicate PD-L1 positivity. a score of 0-1 was considered to indicate PD-L1 negative status.
Up to 5 years from the date of randomization.
Secondary Incidence of toxicity The proportion of patients experiencing a particular adverse event (AE), as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (CTCAE version 5.0 beginning April 1, 2018), for each treatment regimen using the number of patients who received at least one dose of that regimen as the denominator. AEs are AE proportions will be estimated along with a 95% confidence intervals. Up to 30 days after the last study drug administration
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