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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03244384
Other study ID # NCI-2017-01425
Secondary ID NCI-2017-01425A0
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date November 3, 2017
Est. completion date June 1, 2025

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 studies how well pembrolizumab works in treating patients with bladder cancer that has spread into the deep muscle of the bladder wall (muscle-invasive) or urothelial cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Monoclonal antibodies recognizing and blocking checkpoint molecules can enhance the patient's immune response and therefore help fight cancer. Pembrolizumab is one of the monoclonal antibodies that block the PD-1 axis and can interfere with the ability of tumor cells to grow.


Description:

DUAL PRIMARY OBJECTIVE: I. To determine disease free survival (DFS) and overall survival (OS) in all patients with muscle-invasive bladder and upper-tract urothelial carcinoma treated with adjuvant pembrolizumab versus (vs.) observation. SECONDARY OBJECTIVES: I. To determine DFS and OS in PD-L1 positive and negative patients with muscle-invasive bladder and upper-tract urothelial carcinoma treated with adjuvant pembrolizumab vs. observation. II. To characterize the safety and tolerability of pembrolizumab when administered in the adjuvant setting in patients with muscle-invasive bladder and upper-tract urothelial carcinoma. CORRELATIVE SCIENCE OBJECTIVES: I. To determine if the 12 immune gene signatures are associated with OS and DFS. II. To determine if tumor molecular subtype is associated with OS and DFS. III. To investigate whether the diversity of T-cell receptor (TCR) clonotypes is associated with OS and DFS. IV. To investigate whether persistence of TCR clonotypes is associated with OS and DFS. V. To determine if tumor burden and neoantigen burden are associated with OS and DFS. VI. To determine if HLA subtypes are associated with OS and DFS. VII. To conduct exploratory analyses regarding the association of plasma HGF and VEGF levels with IL-10 and IL-17 and OS and DFS and between treated and untreated patients. PHARMACOGENOMIC STUDY OBJECTIVES: I. To investigate the effect of PDCD1 single-nucleotide polymorphism (SNP) rs11568821 on severe (grade 3 or higher) immune-related toxicity in the pembrolizumab-treated cohort. II. To investigate whether other SNPs commonly polymorphic within or near PDCD1 associate with development of pembrolizumab toxicity in the treated cohort. III. To identify novel germline genetic markers of treatment-related toxicity through genome-wide association analysis of pembrolizumab-treated patients. IV. To identify novel germline genetic markers that are associated with DFS and OS through genome-wide association analysis. QUALITY OF LIFE CORRELATIVE STUDY OBJECTIVES: I. To compare health-related quality of life (HRQL) as assessed by the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-core (C)30 between patients randomized to pembrolizumab vs. observation. II. To compare urinary symptoms as assessed by EORTC QLQ- muscle-invasive bladder cancer module (BLM)30 between patients randomized to pembrolizumab vs. observation. III. To compare patient-reported fatigue, diarrhea, and pain between patients randomized to pembrolizumab vs. observation. IV. To compare health utilities and quality-adjusted life year (QALYs) between patients randomized to pembrolizumab vs. observation. V. To compare other scale scores of the EORTC QLQ-C30, EORTC QLQ-BLM30, and European Quality of Life 5 Dimensions 5 Levels (EQ5D-5L) between patients randomized to pembrolizumab vs. observation. VI. To compare global quality of life, symptoms, health utilities, QALYs, and other scale scores of the three questionnaires between patients randomized to pembrolizumab vs. observation within subgroups defined by each of the stratification factors. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo a computed tomography (CT) scan, CT urography, and/or magnetic resonance imaging (MRI) throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study. ARM B: Patients undergo observation. Patients undergo a CT scan, CT urography, and/or MRI throughout the trial. Patients may also undergo a cystoscopy and blood sample collection during screening and on study. After completion of study treatment, patients are followed up every 12 weeks for up 2 years, and then annually for 3 years.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 739
Est. completion date June 1, 2025
Est. primary completion date June 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - PRE-REGISTRATION ELIGIBILITY CRITERIA - Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, urethra, upper tract, or lymph node positive (LN+) disease; variant histology allowed as long as urothelial carcinoma is predominant (any amount of squamous differentiation is allowed); any component of neuroendocrine carcinoma is excluded - Paraffin tissue samples obtained by transurethral resection of muscle-invasive bladder tumor, upper tract resection, or radical cystectomy/nephrectomy/ureterectomy/nephroureterectomy/cystoprostatectomy or urethrectomy must be available; this specimen submission is mandatory prior to registration as results will be used for stratification; specimens from radical/definitive surgery (radical cystectomy/nephrectomy/ureterectomy /nephroureterectomy/cystoprostatectomy and LN dissection) are preferred over transurethral resection, if available - Patient must fit into one of the following three categories: - Patients who received neoadjuvant chemotherapy and pathologic stage at surgical resection is >= pT2 and/or N+ OR - Patients who are not cisplatin-eligible (according to >= 1 of the following criteria: Eastern Cooperative Oncology Group [ECOG] performance status of 2, creatinine clearance < 60 mL/min, grade >= 2 hearing loss, grade >= 2 neuropathy, or New York Heart Association class III heart failure and pathologic stage at surgical resection is >= pT3 or pN+) OR - Patients that decline adjuvant cisplatin-based or other systemic chemotherapy based on an informed discussion with the physician and pathologic stage at surgical resection is >= pT3 or pN+ - The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized; patient must have had radical cystectomy (cystoprostatectomy for men) and lymph node dissection (for bladder primary), or nephrectomy, nephroureterectomy or ureterectomy (for uppertract tumors) or urethrectomy (in addition to a radical cystectomy-either simultaneously or in the past) >= 4 weeks but =< 16 weeks prior to pre-registration; patients who have had a partial cystectomy as definitive therapy are not eligible - No gross cancer at the surgical margins; microscopic invasive urothelial carcinoma positive margins are allowed; carcinoma in situ (CIS) at margins is considered negative margins - No evidence of residual cancer or metastasis after surgery; patients with upper tract urothelial carcinoma must have a negative cystoscopy within 3 months prior to pre-registration; if the bladder has been removed a cystoscopy is not required - No metastatic disease (or radiologic findings "concerning" for metastatic disease) on cross-sectional imaging (according to Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1 criteria) - No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease; human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible - No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years - Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible - Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible - No known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected) - No live vaccine within 30 days prior to the first dose of study drug; examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine; seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed - No postoperative/adjuvant systemic therapy - No prior treatment with any therapy on the PD-1/PD-L1 axis - No treatment with any other type of investigational agent =< 4 weeks before pre-registration - No major surgery =< 4 weeks before pre-registration - No radiation therapy =< 4 weeks before pre-registration - No neoadjuvant chemotherapy =< 4 weeks before pre-registration - Not currently requiring hemodialysis - Age >= 18 years - Not pregnant and not nursing, because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown - ECOG performance status =< 2 - Absolute neutrophil count (ANC) >= 1,200/mm^3 - Leukocytes >= 3,000/ mm^3 - Platelet count >= 75,000/mm^3 - Hemoglobin >= 9 g/dL or >= 5.6 mmol/L - Total bilirubin =< 1.5 x upper limit of normal (ULN) - Bilirubin for patients with Gilbert's =< 3.0 x ULN - Calculated (calc.) creatinine clearance >= 30 mL/min (using either Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation or Cockcroft-Gault formula) - Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3.0 x upper limit of normal (ULN) - Serum albumin >= 2.8 g/dL - For women of childbearing potential only: a negative urine or serum pregnancy test done =< 7 days prior to pre-registration is required - REGISTRATION ELIGIBILITY CRITERIA: Results of central PD-L1 testing available; Q2 Solutions will forward the PD-L1 results to the statistical center and the statistical center will notify the site that the result is available; since the results with be blinded to the site the notification from the Alliance registration/randomization office will serve as a confirmation of this eligibility criteria; after sites receive the confirmation e-mail from Alliance they can register the patient

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Biospecimen Collection
Undergo blood sample collection
Other:
Clinical Observation
Undergo observation
Procedure:
Computed Tomography
Undergo a CT scan
CT Urography
Undergo a CT urography
Cystoscopy
Undergo a cystoscopy
Magnetic Resonance Imaging
Undergo a MRI
Biological:
Pembrolizumab
Given IV
Other:
Pharmacological Study
Correlative studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
Guam FHP Health Center-Guam Tamuning
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 The Queen's Medical Center - West Oahu 'Ewa Beach Hawaii
United States Providence Regional Cancer System-Aberdeen Aberdeen Washington
United States Hendrick Medical Center Abilene Texas
United States Hickman Cancer Center Adrian Michigan
United States Cleveland Clinic Akron General Akron Ohio
United States Summa Health System - Akron Campus Akron Ohio
United States Christus Saint Frances Cabrini Hospital Alexandria Louisiana
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 Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor Michigan
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
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 Messino Cancer Centers Asheville North Carolina
United States Mission Hospital Asheville North Carolina
United States Emory Saint Joseph's Hospital Atlanta Georgia
United States Emory University Hospital Midtown Atlanta Georgia
United States Emory University Hospital/Winship Cancer Institute Atlanta Georgia
United States Grady Health System Atlanta Georgia
United States Northside Hospital Atlanta Georgia
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 Mount Sinai Comprehensive Cancer Center at Aventura Aventura Florida
United States Virginia Mason Bainbridge Island Medical Center Bainbridge Island Washington
United States Saint Alphonsus Medical Center-Baker City Baker City Oregon
United States AIS Cancer Center at San Joaquin Community Hospital Bakersfield California
United States Kaiser Permanente-Baldwin Park Baldwin Park California
United States Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri
United States Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore Maryland
United States MedStar Franklin Square Medical Center/Weinberg Cancer Institute Baltimore Maryland
United States MedStar Union Memorial Hospital Baltimore Maryland
United States Eastern Maine Medical Center Bangor Maine
United States Flaget Memorial Hospital Bardstown Kentucky
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
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 Medical Center of Baton Rouge Baton Rouge Louisiana
United States Ochsner Health Center-Summa Baton Rouge Louisiana
United States Ochsner High Grove 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 National Institutes of Health Clinical Center Bethesda Maryland
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 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 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 Boston Medical Center Boston Massachusetts
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Cancer Center 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 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 University of Michigan - Brighton Center for Specialty Care Brighton Michigan
United States Bristol Regional Medical Center Bristol Tennessee
United States Wellmont Medical Associates-Bristol Bristol Virginia
United States James J Peters VA Medical Center Bronx New York
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 Ascension Southeast Wisconsin Hospital - Elmbrook Campus Brookfield Wisconsin
United States Maimonides Medical Center Brooklyn New York
United States Henry Ford Cancer Institute-Downriver Brownstown Michigan
United States Saint Joseph Regional Cancer Center Bryan Texas
United States Roswell Park Cancer Institute Buffalo New York
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Highline Medical Center-Main Campus Burien Washington
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 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 Saint Joseph Mercy Canton Canton Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - 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 Duke Cancer Institute Cary Cary North Carolina
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 Saint Joseph Mercy Chelsea Chelsea Michigan
United States Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan
United States Cheyenne Regional Medical Center-West Cheyenne Wyoming
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 University of Illinois Chicago Illinois
United States Adena Regional Medical Center Chillicothe Ohio
United States Marshfield Clinic-Chippewa Center Chippewa Falls Wisconsin
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 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 MetroHealth Medical Center Cleveland Ohio
United States Prisma Health Cancer Institute - Laurens Clinton South Carolina
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 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 Coffeyville Regional Medical Center Coffeyville Kansas
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 Memorial Sloan Kettering Commack Commack New York
United States New Hampshire Oncology Hematology PA-Concord Concord New Hampshire
United States Mercy Hospital Coon Rapids Minnesota
United States Bay Area Hospital Coos Bay Oregon
United States Baptist Health Corbin Corbin Kentucky
United States Commonwealth Cancer Center-Corbin Corbin Kentucky
United States Good Samaritan Hospital Corvallis Oregon
United States Alegent Health Mercy Hospital Council Bluffs Iowa
United States Northshore Oncology Associates-Covington Covington Louisiana
United States Greater Regional Medical Center Creston Iowa
United States Siteman Cancer Center at West County Hospital Creve Coeur Missouri
United States Northside Hospital-Forsyth Cumming Georgia
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danbury Hospital Danbury Connecticut
United States Carle at The Riverfront Danville Illinois
United States Geisinger Medical Center Danville Pennsylvania
United States Genesis Cancer Care Institute Davenport Iowa
United States Genesis Medical Center - East Campus Davenport Iowa
United States Iowa Cancer Specialists Davenport Iowa
United States Dayton Physician LLC - Englewood Dayton Ohio
United States Dayton Veterans Affairs Medical Center 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 Beaumont Hospital - Dearborn Dearborn Michigan
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 Northwestern Medicine Cancer Center Kishwaukee DeKalb Illinois
United States Delaware Health Center-Grady Cancer Center Delaware Ohio
United States Delaware Radiation Oncology 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 Western Surgical Care Denver Colorado
United States Smilow Cancer Hospital-Derby Care Center Derby Connecticut
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 Illinois CancerCare-Dixon Dixon Illinois
United States Doylestown Hospital Doylestown Pennsylvania
United States Dublin Methodist Hospital Dublin Ohio
United States Epic Care-Dublin Dublin California
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 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 HSHS Sacred Heart Hospital Eau Claire Wisconsin
United States Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin
United States Mayo Clinic Health System-Eau Claire Clinic 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 Bay Area Breast Surgeons Inc Emeryville California
United States Epic Care Partners in Cancer Care Emeryville California
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 NorthShore University HealthSystem-Evanston Hospital Evanston Illinois
United States Providence Regional Cancer Partnership Everett Washington
United States Fairbanks Memorial Hospital Fairbanks Alaska
United States Inova Schar Cancer Institute Fairfax Virginia
United States Smilow Cancer Hospital Care Center-Fairfield Fairfield Connecticut
United States University of Kansas Clinical Research Center Fairway Kansas
United States Inova Fairfax Hospital Falls Church Virginia
United States Sanford Broadway Medical Center 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 Parkland Health Center - Farmington Farmington Missouri
United States Saint Francis Hospital Federal Way Washington
United States Virginia Mason Federal Way Medical Center Federal Way Washington
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 Aurora Health Center-Fond du Lac 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 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 Parkview Hospital Randallia Fort Wayne Indiana
United States Parkview Regional Medical Center Fort Wayne Indiana
United States UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas
United States Beebe South Coastal Health Campus Frankford Delaware
United States Ascension Saint Francis - Reiman Cancer Center Franklin Wisconsin
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 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 Central Care Cancer Center - Garden City Garden City Kansas
United States Northwestern Medicine Cancer Center Delnor Geneva Illinois
United States Aurora Health Care Germantown Health Center Germantown Wisconsin
United States MultiCare Gig Harbor Medical Park Gig Harbor Washington
United States Tacoma/Valley Radiation Oncology Centers-Gig Harbor Gig Harbor Washington
United States Glens Falls Hospital Glens Falls New York
United States NorthShore University HealthSystem-Glenbrook Hospital Glenview Illinois
United States National Jewish Health-Western Hematology Oncology Golden Colorado
United States Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina
United States Wayne Memorial Hospital Goldsboro North Carolina
United States CTCA at Western Regional Medical Center Goodyear Arizona
United States Aurora Cancer Care-Grafton Grafton Wisconsin
United States Nebraska Cancer Specialists/Oncology Hematology West PC Grand Island Nebraska
United States Grand Valley Oncology Grand Junction Colorado
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 Helen DeVos Children's Hospital at Spectrum Health 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 Aurora BayCare Medical Center Green Bay Wisconsin
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 East Carolina University Greenville North Carolina
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 Greenwich Hospital Greenwich Connecticut
United States Smilow Cancer Hospital Care Center at Greenwich Greenwich Connecticut
United States Self Regional Healthcare Greenwood South Carolina
United States Gibbs Cancer Center-Pelham Greer South Carolina
United States Prisma Health Cancer Institute - Greer Greer South Carolina
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 Smilow Cancer Hospital Care Center - Guilford Guilford Connecticut
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 Memorial Sloan Kettering Westchester Harrison New York
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
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
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United States Cancer Center of Western Wisconsin New Richmond Wisconsin
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United States Laura and Isaac Perlmutter Cancer Center at NYU Langone New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
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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
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United States USC Norris Oncology/Hematology-Newport Beach Newport Beach California
United States Dana-Farber Cancer Institute - Chestnut Hill Newton Massachusetts
United States Corewell Health Lakeland Hospitals - Niles Hospital Niles Michigan
United States Bon Secours DePaul Medical Center Norfolk Virginia
United States Yale-New Haven Hospital North Haven Medical Center North Haven Connecticut
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United States Henry Ford Medical Center-Columbus Novi Michigan
United States Cancer Care Center of O'Fallon O'Fallon Illinois
United States Alta Bates Summit Medical Center - Summit Campus Oakland California
United States Bay Area Tumor Institute 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
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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 Baptist Memorial Hospital and Cancer Center-Oxford Oxford Mississippi
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United States Hope Cancer Care of Nevada-Pahrump Pahrump Nevada
United States Stanford Cancer Institute Palo Alto Palo Alto California
United States Kaiser Permanente - Panorama City Panorama City California
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United States Camden Clark Medical Center Parkersburg West Virginia
United States Keck Medical Center of USC Pasadena Pasadena California
United States Lahey Medical Center-Peabody Peabody Massachusetts
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United States MultiCare Good Samaritan Hospital Puyallup Washington
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United States Maine Medical Partners - South Portland South Portland Maine
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United States Memorial Medical Center Springfield Illinois
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United States Mercy Medical Center Springfield Massachusetts
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United States Geisinger Medical Group State College Pennsylvania
United States Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan
United States Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin
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United States Stony Brook University Medical Center Stony Brook New York
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United States Missouri Baptist Sullivan Hospital Sullivan Missouri
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United States MGC Hematology Oncology-Union Union South Carolina
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United States Carle Cancer Center Urbana Illinois
United States The Carle Foundation Hospital Urbana Illinois
United States Faxton-Saint Luke's Healthcare Utica New York
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United States Legacy Salmon Creek Hospital Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Upstate Cancer Center at Verona Verona New York
United States Ridgeview Medical Center Waconia Minnesota
United States Providence Saint Mary Regional Cancer Center Walla Walla Washington
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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
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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 Sibley Memorial Hospital Washington District of Columbia
United States Smilow Cancer Hospital-Waterbury Care Center Waterbury Connecticut
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United States Marshfield Clinic-Wausau Center Wausau Wisconsin
United States Ascension Medical Group Southeast Wisconsin - Mayfair Road Wauwatosa Wisconsin
United States Aurora Cancer Care-Milwaukee West Wauwatosa Wisconsin
United States AdventHealth Infusion Center Weaverville Weaverville North Carolina
United States Aurora West Allis Medical Center West Allis Wisconsin
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 Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa
United States Reading Hospital West Reading Pennsylvania
United States Smilow Cancer Hospital Care Center - Westerly Westerly Rhode Island
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 Dickstein Cancer Treatment Center White Plains New York
United States Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania
United States Rice Memorial Hospital Willmar Minnesota
United States Christiana Care Health System-Wilmington Hospital Wilmington Delaware
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 Sanford Cancer Center Worthington Worthington Minnesota
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,  Guam, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented. From randomization to the date of death from any cause, assessed up to 5 years
Primary Disease-free survival The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented. From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years
Secondary Overall survival in PD-L1 positive and negative patients The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented. From randomization to the date of death from any cause, assessed up to 5 years
Secondary Disease-free survival in PD-L1 positive and negative patients The stratified proportional hazards model will be the primary analysis. The hazard ratio and its 95% confidence interval from the stratified Cox model with a single treatment covariate will be reported. The unstratified hazard ratio will also be presented. From randomization to the first metastatic recurrence (presence of any recurrent disease), or death, whichever occurs first, assessed up to 5 years
See also
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