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Testando a adição da droga anticâncer, Cabozantinib, ao tratamento usual de imunoterapia, Avelumab, em pacientes com câncer urotelial metastático, estudo MAIN-CAV

23 de outubro de 2026 atualizado por: National Cancer Institute (NCI)

MAIN-CAV: Estudo randomizado de fase III de manutenção de cabozantinibe e avelumabe versus manutenção de avelumabe após quimioterapia de primeira linha à base de platina em pacientes com câncer urotelial metastático

This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVE:

I. To evaluate the effect of cabozantinib (cabozantinib S-malate) in combination with avelumab on overall survival (OS) compared to avelumab alone in patients with metastatic urothelial cancer (mUC) who did not progress during first-line platinum-based chemotherapy therapy, i.e. patients who had complete response (CR), partial response (PR) or stable disease (SD) after completion of first line platinum-based chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the effect of cabozantinib in combination with avelumab on progression-free survival (PFS) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

II. To evaluate the safety and tolerability of cabozantinib in combination with avelumab in mUC compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

III. To evaluate activity of cabozantinib in combination with avelumab based on Response Evaluation Criteria in Solid Tumors (RECIST) compared to avelumab alone for maintenance treatment following initial first-line treatment in patients who had a CR, PR or SD upon completion of first-line platinum-based chemotherapy.

IV. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

V. To evaluate the activity of cabozantinib in combination with avelumab compared to avelumab alone based on PD-L1 status of patients' tumors.

QUALITY OF LIFE (QOL) OBJECTIVES:

I. To compare quality-adjusted survival between patients randomized to receive cabozantinib and avelumab versus (vs.) avelumab alone using the European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L).

II. To compare patient-reported fatigue as assessed by the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 4a from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

III. To compare patient-reported global health status/quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30 from baseline through 12 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

IV. To compare scale scores of the EORTC QLQ-Bladder Cancer Muscle-Invasive (BLM)30 (urinary symptoms, urostomy problems, catheter problems, future perspectives, abdominal bloating and flatulence, body image, sexual function) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

V. To compare scale scores of the EORTC QLQ-C30 (global health status/quality of life; physical, role, emotional, cognitive, and social function; symptoms) at 3, 6, 12, 18, and 24 months between patients randomized to receive cabozantinib and avelumab vs. avelumab alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive avelumab intravenously (IV) over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo computed tomography (CT) or magnetic resonance imaging (MRI) and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.

ARM B: Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib orally (PO) daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.

After completion of study treatment, patients are followed every 30 days through 90 days, then every 3 months for 5 years.

Tipo de estudo

Intervencional

Inscrição (Estimado)

654

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canadá, M5G 2M9
        • University Health Network-Princess Margaret Hospital
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4T 7T1
        • Allan Blair Cancer Centre
      • Saskatoon, Saskatchewan, Canadá, S7N 4H4
        • Saskatoon Cancer Centre
  • Estados Unidos
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85054
        • Mayo Clinic Hospital in Arizona
    • California
      • Auburn, California, Estados Unidos, 95602
        • Sutter Auburn Faith Hospital
      • Berkeley, California, Estados Unidos, 94704
        • Alta Bates Summit Medical Center-Herrick Campus
      • Fremont, California, Estados Unidos, 94538
        • Palo Alto Medical Foundation-Fremont
      • Modesto, California, Estados Unidos, 95355
        • Memorial Medical Center
      • Mountain View, California, Estados Unidos, 94040
        • Palo Alto Medical Foundation-Camino Division
      • Palo Alto, California, Estados Unidos, 94301
        • Palo Alto Medical Foundation Health Care
      • Roseville, California, Estados Unidos, 95661
        • Sutter Roseville Medical Center
      • Sacramento, California, Estados Unidos, 95816
        • Sutter Medical Center Sacramento
      • Sacramento, California, Estados Unidos, 95817
        • University of California Davis Comprehensive Cancer Center
      • San Francisco, California, Estados Unidos, 94115
        • California Pacific Medical Center-Pacific Campus
      • Santa Cruz, California, Estados Unidos, 95065
        • Palo Alto Medical Foundation-Santa Cruz
      • Sunnyvale, California, Estados Unidos, 94086
        • Palo Alto Medical Foundation-Sunnyvale
      • Vallejo, California, Estados Unidos, 94589
        • Sutter Solano Medical Center/Cancer Center
    • Delaware
      • Millville, Delaware, Estados Unidos, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, Estados Unidos, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, Estados Unidos, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, Estados Unidos, 19971
        • Beebe Health Campus
    • District of Columbia
      • Washington D.C., District of Columbia, Estados Unidos, 20010
        • MedStar Washington Hospital Center
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • UF Health Cancer Institute - Gainesville
      • Jacksonville, Florida, Estados Unidos, 32224-9980
        • Mayo Clinic in Florida
      • Weston, Florida, Estados Unidos, 33331
        • Cleveland Clinic-Weston
    • Illinois
      • Aurora, Illinois, Estados Unidos, 60504
        • Rush-Copley Medical Center
      • Barrington, Illinois, Estados Unidos, 60010
        • Advocate Good Shepherd Hospital
      • Bloomington, Illinois, Estados Unidos, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, Estados Unidos, 61520
        • Illinois CancerCare-Canton
      • Carthage, Illinois, Estados Unidos, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Estados Unidos, 62801
        • Centralia Oncology Clinic
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • Chicago, Illinois, Estados Unidos, 60612
        • University of Illinois
      • Chicago, Illinois, Estados Unidos, 60657
        • Advocate Illinois Masonic Medical Center
      • Chicago, Illinois, Estados Unidos, 60612
        • Rush MD Anderson Cancer Center
      • Crystal Lake, Illinois, Estados Unidos, 60014
        • AMG Crystal Lake - Oncology
      • Danville, Illinois, Estados Unidos, 61832
        • Carle at The Riverfront
      • DeKalb, Illinois, Estados Unidos, 60115
        • Northwestern Medicine Cancer Center Kishwaukee
      • Decatur, Illinois, Estados Unidos, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, Estados Unidos, 61021
        • Illinois CancerCare-Dixon
      • Downers Grove, Illinois, Estados Unidos, 60515
        • Advocate Good Samaritan Hospital
      • Effingham, Illinois, Estados Unidos, 62401
        • Crossroads Cancer Center
      • Effingham, Illinois, Estados Unidos, 62401
        • Carle Physician Group-Effingham
      • Elgin, Illinois, Estados Unidos, 60123
        • Advocate Sherman Hospital
      • Eureka, Illinois, Estados Unidos, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, Estados Unidos, 61401
        • Illinois CancerCare-Galesburg
      • Geneva, Illinois, Estados Unidos, 60134
        • Northwestern Medicine Cancer Center Delnor
      • Hazel Crest, Illinois, Estados Unidos, 60429
        • Advocate South Suburban Hospital
      • Kewanee, Illinois, Estados Unidos, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, Estados Unidos, 60045
        • Northwestern Medicine Lake Forest Hospital
      • Libertyville, Illinois, Estados Unidos, 60048
        • Condell Memorial Hospital
      • Libertyville, Illinois, Estados Unidos, 60048
        • AMG Libertyville - Oncology
      • Macomb, Illinois, Estados Unidos, 61455
        • Illinois CancerCare-Macomb
      • Mattoon, Illinois, Estados Unidos, 61938
        • Carle Physician Group-Mattoon/Charleston
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Cancer Care Center of O'Fallon
      • Oak Lawn, Illinois, Estados Unidos, 60453-2699
        • Advocate Christ Medical Center
      • Ottawa, Illinois, Estados Unidos, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Park Ridge, Illinois, Estados Unidos, 60068
        • Advocate Lutheran General Hospital
      • Pekin, Illinois, Estados Unidos, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, Estados Unidos, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, Estados Unidos, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Estados Unidos, 61356
        • Illinois CancerCare-Princeton
      • Rockford, Illinois, Estados Unidos, 61114
        • UW Health Carbone Cancer Center Rockford
      • Shiloh, Illinois, Estados Unidos, 62269
        • Memorial Hospital East
      • Springfield, Illinois, Estados Unidos, 62702
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Estados Unidos, 62702
        • Springfield Clinic
      • Springfield, Illinois, Estados Unidos, 62781
        • Springfield Memorial Hospital
      • Urbana, Illinois, Estados Unidos, 61801
        • Carle Cancer Center
      • Warrenville, Illinois, Estados Unidos, 60555
        • Northwestern Medicine Cancer Center Warrenville
      • Washington, Illinois, Estados Unidos, 61571
        • Illinois CancerCare - Washington
      • Yorkville, Illinois, Estados Unidos, 60560
        • Rush-Copley Healthcare Center
    • Indiana
      • Crown Point, Indiana, Estados Unidos, 46307
        • Northwest Cancer Center - Crown Point
      • Dyer, Indiana, Estados Unidos, 46311
        • Northwest Oncology LLC
      • Hobart, Indiana, Estados Unidos, 46342
        • Northwest Cancer Center - Hobart
      • Hobart, Indiana, Estados Unidos, 46342
        • Saint Mary Medical Center
      • Indianapolis, Indiana, Estados Unidos, 46312
        • Saint Catherine Hospital
      • Munster, Indiana, Estados Unidos, 46321
        • The Community Hospital
      • Munster, Indiana, Estados Unidos, 46321
        • Women's Diagnostic Center - Munster
      • Valparaiso, Indiana, Estados Unidos, 46383
        • Northwest Cancer Center - Valparaiso
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • Mary Greeley Medical Center
      • Ames, Iowa, Estados Unidos, 50010
        • McFarland Clinic - Ames
      • Boone, Iowa, Estados Unidos, 50036
        • McFarland Clinic - Boone
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • McFarland Clinic - Trinity Cancer Center
      • Iowa City, Iowa, Estados Unidos, 52242
        • University of Iowa/Holden Comprehensive Cancer Center
      • Jefferson, Iowa, Estados Unidos, 50129
        • McFarland Clinic - Jefferson
      • Marshalltown, Iowa, Estados Unidos, 50158
        • McFarland Clinic - Marshalltown
    • Kentucky
      • Louisville, Kentucky, Estados Unidos, 40207
        • Baptist Health Louisville
    • Maine
      • Augusta, Maine, Estados Unidos, 04330
        • Harold Alfond Center for Cancer Care
    • Maryland
      • Bethesda, Maryland, Estados Unidos, 20892
        • National Institutes of Health Clinical Center
    • Massachusetts
      • Worcester, Massachusetts, Estados Unidos, 01655
        • UMass Memorial Medical Center - University Campus
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Bronson Battle Creek
      • Brighton, Michigan, Estados Unidos, 48114
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
      • Brighton, Michigan, Estados Unidos, 48114
        • Trinity Health Medical Center - Brighton
      • Canton, Michigan, Estados Unidos, 48188
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
      • Canton, Michigan, Estados Unidos, 48188
        • Trinity Health Medical Center - Canton
      • Chelsea, Michigan, Estados Unidos, 48118
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
      • Chelsea, Michigan, Estados Unidos, 48118
        • Chelsea Hospital
      • Clarkston, Michigan, Estados Unidos, 48346
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, Estados Unidos, 48346
        • Newland Medical Associates-Clarkston
      • Flint, Michigan, Estados Unidos, 48503
        • Hurley Medical Center
      • Flint, Michigan, Estados Unidos, 48503
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Estados Unidos, 48503
        • Genesys Hurley Cancer Institute
      • Flint, Michigan, Estados Unidos, 48503
        • Cancer Hematology Centers - Flint
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • West Michigan Cancer Center
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • Bronson Methodist Hospital
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • Beacon Kalamazoo Cancer Center
      • Lansing, Michigan, Estados Unidos, 48912
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Estados Unidos, 48154
        • Trinity Health Saint Mary Mercy Livonia Hospital
      • Macomb, Michigan, Estados Unidos, 48044
        • Henry Ford Saint John Hospital - Macomb Medical
      • Muskegon, Michigan, Estados Unidos, 49444
        • Trinity Health Muskegon Hospital
      • Norton Shores, Michigan, Estados Unidos, 49444
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Pontiac, Michigan, Estados Unidos, 48341
        • Hope Cancer Center
      • Pontiac, Michigan, Estados Unidos, 48341
        • Trinity Health Saint Joseph Mercy Oakland Hospital
      • Pontiac, Michigan, Estados Unidos, 48341
        • Michigan Healthcare Professionals Pontiac
      • Pontiac, Michigan, Estados Unidos, 48341
        • Trinity Health IHA Medical Group-Alice Gustafson Center
      • Reed City, Michigan, Estados Unidos, 49677
        • Corewell Health Reed City Hospital
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
      • Traverse City, Michigan, Estados Unidos, 49684
        • Munson Medical Center
      • Wyoming, Michigan, Estados Unidos, 49519
        • University of Michigan Health - West
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
      • Ypsilanti, Michigan, Estados Unidos, 48106
        • Huron Gastroenterology PC
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
        • Sanford Joe Lueken Cancer Center
      • Minneapolis, Minnesota, Estados Unidos, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Abbott-Northwestern Hospital
      • Rochester, Minnesota, Estados Unidos, 55905
        • Mayo Clinic in Rochester
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Coborn Cancer Center at Saint Cloud Hospital
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Regions Hospital
      • Willmar, Minnesota, Estados Unidos, 56201
        • Rice Memorial Hospital
    • Missouri
      • Cape Girardeau, Missouri, Estados Unidos, 63703
        • Saint Francis Medical Center
      • City of Saint Peters, Missouri, Estados Unidos, 63376
        • Siteman Cancer Center at Saint Peters Hospital
      • Columbia, Missouri, Estados Unidos, 65212
        • MU Health - University Hospital/Ellis Fischel Cancer Center
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Siteman Cancer Center at West County Hospital
      • Kansas City, Missouri, Estados Unidos, 64111
        • Saint Luke's Hospital of Kansas City
      • Lee's Summit, Missouri, Estados Unidos, 64086
        • Saint Luke's East - Lee's Summit
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine
      • St Louis, Missouri, Estados Unidos, 63129
        • Siteman Cancer Center-South County
      • St Louis, Missouri, Estados Unidos, 63136
        • Siteman Cancer Center at Christian Hospital
      • St Louis, Missouri, Estados Unidos, 63141
        • Mercy Hospital Saint Louis
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Estados Unidos, 89183
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Concord, New Hampshire, Estados Unidos, 03301
        • New Hampshire Oncology Hematology PA-Concord
      • Manchester, New Hampshire, Estados Unidos, 03103
        • Solinsky Center for Cancer Care
    • New Jersey
      • Basking Ridge, New Jersey, Estados Unidos, 07920
        • Memorial Sloan Kettering Basking Ridge
      • Hackensack, New Jersey, Estados Unidos, 07601
        • Hackensack University Medical Center
      • Middletown, New Jersey, Estados Unidos, 07748
        • Memorial Sloan Kettering Monmouth
      • Montvale, New Jersey, Estados Unidos, 07645
        • Memorial Sloan Kettering Bergen
      • Morristown, New Jersey, Estados Unidos, 07960
        • Morristown Medical Center
      • Paterson, New Jersey, Estados Unidos, 07503
        • Saint Joseph's Regional Medical Center
      • Summit, New Jersey, Estados Unidos, 07902
        • Overlook Hospital
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • University of New Mexico Cancer Center
      • Las Cruces, New Mexico, Estados Unidos, 88011
        • Memorial Medical Center-Las Cruces
    • New York
      • Commack, New York, Estados Unidos, 11725
        • Memorial Sloan Kettering Commack
      • Elmira, New York, Estados Unidos, 14905
        • Arnot Ogden Medical Center/Falck Cancer Center
      • Glens Falls, New York, Estados Unidos, 12801
        • Glens Falls Hospital
      • Harrison, New York, Estados Unidos, 10604
        • Memorial Sloan Kettering Westchester
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
      • Oswego, New York, Estados Unidos, 13126
        • Upstate Cancer Center at Oswego
      • Stony Brook, New York, Estados Unidos, 11794
        • Stony Brook University Medical Center
      • Syracuse, New York, Estados Unidos, 13210
        • State University of New York Upstate Medical University
      • Syracuse, New York, Estados Unidos, 13215
        • SUNY Upstate Medical Center-Community Campus
      • Uniondale, New York, Estados Unidos, 11553
        • Memorial Sloan Kettering Nassau
      • Verona, New York, Estados Unidos, 13478
        • Upstate Cancer Center at Verona
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28203
        • Carolinas Medical Center/Levine Cancer Institute
      • Charlotte, North Carolina, Estados Unidos, 28262
        • Atrium Health University City/LCI-University
      • Charlotte, North Carolina, Estados Unidos, 28211
        • Levine Cancer Institute-SouthPark
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Levine Cancer Institute-Ballantyne
      • Clinton, North Carolina, Estados Unidos, 28328
        • Southeastern Medical Oncology Center-Clinton
      • Concord, North Carolina, Estados Unidos, 28025
        • Atrium Health Cabarrus/LCI-Concord
      • Goldsboro, North Carolina, Estados Unidos, 27534
        • Southeastern Medical Oncology Center-Goldsboro
      • Jacksonville, North Carolina, Estados Unidos, 28546
        • Southeastern Medical Oncology Center-Jacksonville
      • Lincolnton, North Carolina, Estados Unidos, 28092
        • Atrium Health Lincoln/LCI-Lincolnton
      • Shelby, North Carolina, Estados Unidos, 28150
        • Atrium Health Cleveland/LCI-Cleveland
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Wake Forest University Health Sciences
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
        • Sanford Bismarck Medical Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Estados Unidos, 58122
        • Sanford Broadway Medical Center
    • Ohio
      • Akron, Ohio, Estados Unidos, 44307
        • Cleveland Clinic Akron General
      • Centerville, Ohio, Estados Unidos, 45459
        • Miami Valley Hospital South
      • Cleveland, Ohio, Estados Unidos, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, Estados Unidos, 44111
        • Cleveland Clinic Cancer Center/Fairview Hospital
      • Dayton, Ohio, Estados Unidos, 45415
        • Miami Valley Hospital North
      • Dayton, Ohio, Estados Unidos, 45415
        • Dayton Physician LLC - Englewood
      • Dayton, Ohio, Estados Unidos, 45409
        • Premier Blood and Cancer Center
      • Franklin, Ohio, Estados Unidos, 45005-1066
        • Atrium Medical Center-Middletown Regional Hospital
      • Greenville, Ohio, Estados Unidos, 45331
        • Miami Valley Cancer Care and Infusion
      • Kettering, Ohio, Estados Unidos, 45429
        • Kettering Medical Center
      • Mansfield, Ohio, Estados Unidos, 44906
        • Cleveland Clinic Cancer Center Mansfield
      • Mayfield Heights, Ohio, Estados Unidos, 44124
        • Hillcrest Hospital Cancer Center
      • Sandusky, Ohio, Estados Unidos, 44870
        • North Coast Cancer Care
      • Strongsville, Ohio, Estados Unidos, 44136
        • Cleveland Clinic Cancer Center Strongsville
      • Toledo, Ohio, Estados Unidos, 43623
        • Toledo Clinic Cancer Centers-Toledo
      • Troy, Ohio, Estados Unidos, 45373
        • Upper Valley Medical Center
      • Warrensville Heights, Ohio, Estados Unidos, 44122
        • South Pointe Hospital
      • Wooster, Ohio, Estados Unidos, 44691
        • Cleveland Clinic Wooster Family Health and Surgery Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Health Sciences Center
      • Tulsa, Oklahoma, Estados Unidos, 74146
        • Oklahoma Cancer Specialists and Research Institute-Tulsa
    • Oregon
      • Gresham, Oregon, Estados Unidos, 97030
        • Legacy Mount Hood Medical Center
      • Portland, Oregon, Estados Unidos, 97210
        • Legacy Good Samaritan Hospital and Medical Center
      • Tualatin, Oregon, Estados Unidos, 97062
        • Legacy Meridian Park Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18103
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Estados Unidos, 18017
        • Lehigh Valley Hospital - Muhlenberg
      • Harrisburg, Pennsylvania, Estados Unidos, 17111
        • Penn State Health Medical Group - Andrews Patel Hematology/Oncology East
      • Hershey, Pennsylvania, Estados Unidos, 17033-0850
        • Penn State Milton S Hershey Medical Center
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, Estados Unidos, 19148
        • Jefferson Methodist Hospital
    • South Carolina
      • Boiling Springs, South Carolina, Estados Unidos, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Charleston, South Carolina, Estados Unidos, 29425
        • Medical University of South Carolina
      • Easley, South Carolina, Estados Unidos, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, Estados Unidos, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Estados Unidos, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Estados Unidos, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Estados Unidos, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Estados Unidos, 29650
        • Prisma Health Cancer Institute - Greer
      • Rock Hill, South Carolina, Estados Unidos, 29732
        • Levine Cancer Institute-Rock Hill
      • Seneca, South Carolina, Estados Unidos, 29672
        • Prisma Health Cancer Institute - Seneca
    • South Dakota
      • Aberdeen, South Dakota, Estados Unidos, 57401
        • Avera Cancer Institute-Aberdeen
      • Rapid City, South Dakota, Estados Unidos, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, Estados Unidos, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5134
        • Sanford USD Medical Center - Sioux Falls
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Sanford Cancer Center Oncology Clinic
      • Yankton, South Dakota, Estados Unidos, 57078
        • Avera Cancer Institute at Yankton
    • Tennessee
      • Alcoa, Tennessee, Estados Unidos, 37701
        • University Cancer Specialists - Alcoa
      • Knoxville, Tennessee, Estados Unidos, 37920
        • University of Tennessee - Knoxville
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • UT Southwestern/Simmons Cancer Center-Dallas
      • Dallas, Texas, Estados Unidos, 75237
        • UT Southwestern Simmons Cancer Center - RedBird
      • Fort Worth, Texas, Estados Unidos, 76104
        • UT Southwestern/Simmons Cancer Center-Fort Worth
      • Richardson, Texas, Estados Unidos, 75080
        • UT Southwestern Clinical Center at Richardson/Plano
    • Virginia
      • Mechanicsville, Virginia, Estados Unidos, 23116
        • Bon Secours Memorial Regional Medical Center
      • Midlothian, Virginia, Estados Unidos, 23114
        • Bon Secours Saint Francis Medical Center
      • Richmond, Virginia, Estados Unidos, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Estados Unidos, 23229
        • Virginia Cancer Institute
      • Richmond, Virginia, Estados Unidos, 23226
        • Bon Secours Saint Mary's Hospital
      • Richmond, Virginia, Estados Unidos, 23298
        • VCU Massey Comprehensive Cancer Center
      • South Hill, Virginia, Estados Unidos, 23970
        • VCU Community Memorial Health Center
      • Winchester, Virginia, Estados Unidos, 22601
        • Shenandoah Oncology PC
    • Washington
      • Renton, Washington, Estados Unidos, 98055
        • Valley Medical Center
      • Vancouver, Washington, Estados Unidos, 98686
        • Legacy Salmon Creek Hospital
      • Vancouver, Washington, Estados Unidos, 98684
        • Legacy Cancer Institute Medical Oncology and Day Treatment
    • West Virginia
      • Charleston, West Virginia, Estados Unidos, 25304
        • Vandalia Health/CAMC Institute for Academic Medicine
    • Wisconsin
      • Burlington, Wisconsin, Estados Unidos, 53105
        • Aurora Cancer Care-Southern Lakes VLCC
      • Eau Claire, Wisconsin, Estados Unidos, 54701
        • Marshfield Medical Center-EC Cancer Center
      • Germantown, Wisconsin, Estados Unidos, 53022
        • Aurora Health Care Germantown Health Center
      • Grafton, Wisconsin, Estados Unidos, 53024
        • Aurora Cancer Care-Grafton
      • Green Bay, Wisconsin, Estados Unidos, 54311
        • Aurora BayCare Medical Center
      • Kenosha, Wisconsin, Estados Unidos, 53142
        • Aurora Cancer Care-Kenosha South
      • Marinette, Wisconsin, Estados Unidos, 54143
        • Aurora Bay Area Medical Group-Marinette
      • Marshfield, Wisconsin, Estados Unidos, 54449
        • Marshfield Medical Center-Marshfield
      • Menomonee Falls, Wisconsin, Estados Unidos, 53051
        • Froedtert Menomonee Falls Hospital
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Medical College of Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53209
        • Aurora Cancer Care-Milwaukee
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Aurora Saint Luke's Medical Center
      • Milwaukee, Wisconsin, Estados Unidos, 53233
        • Aurora Sinai Medical Center
      • Minocqua, Wisconsin, Estados Unidos, 54548
        • Marshfield Medical Center - Minocqua
      • Mukwonago, Wisconsin, Estados Unidos, 53149
        • ProHealth D N Greenwald Center
      • New Richmond, Wisconsin, Estados Unidos, 54017
        • Cancer Center of Western Wisconsin
      • Oak Creek, Wisconsin, Estados Unidos, 53154
        • Drexel Town Square Health Center
      • Oconomowoc, Wisconsin, Estados Unidos, 53066
        • ProHealth Oconomowoc Memorial Hospital
      • Oshkosh, Wisconsin, Estados Unidos, 54904
        • Vince Lombardi Cancer Clinic - Oshkosh
      • Racine, Wisconsin, Estados Unidos, 53406
        • Aurora Cancer Care-Racine
      • Rice Lake, Wisconsin, Estados Unidos, 54868
        • Marshfield Medical Center-Rice Lake
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Vince Lombardi Cancer Clinic-Sheboygan
      • Stevens Point, Wisconsin, Estados Unidos, 54482
        • Marshfield Medical Center-River Region at Stevens Point
      • Summit, Wisconsin, Estados Unidos, 53066
        • Aurora Medical Center in Summit
      • Two Rivers, Wisconsin, Estados Unidos, 54241
        • Vince Lombardi Cancer Clinic-Two Rivers
      • Waukesha, Wisconsin, Estados Unidos, 53188
        • UW Cancer Center at ProHealth Care
      • Waukesha, Wisconsin, Estados Unidos, 53188
        • ProHealth Waukesha Memorial Hospital
      • Wauwatosa, Wisconsin, Estados Unidos, 53226
        • Aurora Cancer Care-Milwaukee West
      • West Allis, Wisconsin, Estados Unidos, 53227
        • Aurora West Allis Medical Center
      • West Bend, Wisconsin, Estados Unidos, 53095
        • Froedtert West Bend Hospital/Kraemer Cancer Center
      • Weston, Wisconsin, Estados Unidos, 54476
        • Marshfield Medical Center - Weston

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Histologically or cytologically-confirmed diagnosis of advanced or metastatic urothelial cancer of the renal pelvis, ureter, bladder, or urethra (transitional cell and mixed transitional/non-transitional cell histologies except for small-cell histology), including N3 only disease prior to start of first-line platinum-based chemotherapy

  • Prior first-line treatment must have consisted of 4-6 cycles of 1st-line therapy (platinum-based chemotherapy; gemcitabine-cisplatin, gemcitabine-carboplatin, methotrexate, vinblastine, doxorubicin and cisplatin [MVAC] or dose-dense [dd]MVAC)

  • No more than 1 line of prior chemotherapy for metastatic or locally advanced disease (neoadjuvant or adjuvant chemotherapy will be allowed if given 12 or more months prior to registration)

  • Tumor objective response of CR, PR, or SD upon completion of first line platinum-based chemotherapy by treating physician's assessment

  • The last dose of first-line chemotherapy must have been received no less than 3 weeks, and no more than 10 weeks, prior to randomization in the present study

  • No prior immunotherapy with IL-2, IFN-alpha, or an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or CTLA-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

  • Age >= 18 years

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  • Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects

  • Women of childbearing potential must have a negative pregnancy test =< 14 days prior to registration.

    • Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea >= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason

  • No use of immunosuppressive medication within 7 days prior to randomization except:

    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection);
    • Systemic corticosteroids at physiologic doses =< 10 mg/day of prednisone or equivalent;
    • Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

  • Patients with diabetes type I, vitiligo, psoriasis, or hypo or hyperthyroid disease not requiring immunosuppressive treatment are eligible

  • None of the following:

    • Active autoimmune disease that might deteriorate when receiving the anti PD-L1 agent, avelumab.

    • No known symptomatic central nervous system (CNS) metastases. Patients with previously diagnosed CNS metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued corticosteroid treatment for at least 2 weeks, and are neurologically stable. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility.

    • No major surgery within 4 weeks prior to randomization. Subjects must have complete wound healing from surgery before randomization. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.

    • No palliative radiotherapy within 48 hours prior to patient randomization.

    • No hemoptysis of ≥ 0.5 teaspoon (2.5 mL) of red blood, clinically significant hematuria, hematemesis, coagulopathy, or other history of significant bleeding (eg. Pulmonary hemorrhage) within 3 months before randomization.

    • No known cavitating pulmonary lesion(s) or known endobronchial disease manifestation.

    • No administration of a live, attenuated vaccine within 30 days prior to randomization. The use of inactivated (killed) vaccines for the prevention of infectious disease is permitted. The use of COVID-19 vaccines is permitted.

    • No uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:

      • Cardiovascular disorders including:

        • Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.
        • Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic, or > 90 mm Hg diastolic despite optimal antihypertensive treatment.
        • The patient has a known history of corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms and confirmed by electrocardiogram (ECG) within 28 days before randomization. Note: if initial QTcF is found to be > 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is ≤ 500 ms, the subject meets eligibility in this regard.
        • Any history of congenital long QT syndrome.
        • Stroke, transient ischemic attack (TIA), myocardial infarction, or other symptomatic ischemic event or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism [DVT/PE]) within 6 months before randomization. Subjects with a diagnosis of incidental, subsegmental PE or DVT within 6 months are allowed if asymptomatic and stable at screening and treated with low molecular weight heparin (LMWH) or the direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban for at least 1 week before randomization. Non-symptomatic white matter disease in the brain is acceptable.

      • No significant gastrointestinal disorders, particularly those associated with a high risk of perforation or fistula formation including unresolved active peptic ulcer disease, cholecystitis, diverticultis, symptomatic cholangitis or appendicitis, or malabsorption syndrome within 28 days of randomization.

      • No other clinically significant disorders such as:

        • Any active infection requiring systemic treatment within 14 days before randomization. Subjects receiving oral (including prophylactic) antibiotics with no symptoms of infection at randomization are eligible.
        • Serious non-healing wound/ulcer/bone fracture within 28 days before randomization
        • History of organ or allogeneic stem cell transplant

      • No persisting toxicity related to prior therapy grade > 2 constituting a safety risk based on the investigator's judgment.

      • No diagnosis of any other malignancy within 3 years prior to randomization, except for locally curable cancers that have been adequately treated such as basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, Gleason < 7 prostate cancer on surveillance without any plans for treatment intervention (eg, surgery, radiation, or castration), or prostate cancer that has been adequately treated with prostatectomy or radiotherapy and currently with no evidence of disease or symptoms and no indication for treatment.

      • No concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel).

        • Allowed anticoagulants are the following:

          • Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, or apixaban in subjects without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor

  • Absolute neutrophil count (ANC) >= 1,000/mm^3

  • Platelet count >= 100,000/mm^3

  • Hemoglobin >= 8 g/dL

  • Calculated (Calc.) creatinine clearance >= 30 mL/min using the Cockcroft-Gault equation

  • Total serum bilirubin =< 1.5 x upper limit of normal (ULN)

  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN (or =< 5 x ULN for patients with liver metastases or Gilbert's disease)

  • Urine protein creatinine (UPC) ratio =< 1 or 24-hour protein < 1 g

  • Physicians should consider whether any of the following may render the patient inappropriate for this protocol:

    • Psychiatric illness which would prevent the patient from giving informed consent.
    • Uncontrolled medical conditions which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
    • Patients who cannot swallow oral formulations of the agent(s).

In addition:

  • Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom).
  • Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and or steroids equivalent to < 10 mg prednisone daily, not on immunosuppressive medications and patients with positive serology are eligible. Patients with vitiligo, endocrine deficiencies including hypo or hyper thyroid disease managed with replacement, diabetes type 1 are eligible.
  • Sexually active subjects (men and women) must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and continue for 4 months after the last dose of study drugs, even if oral contraceptives are also used.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm A (avelumab)

Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.
Outro: Quality-of-Life Assessment

Ancillary studies

Outros nomes:
  • Avaliação da Qualidade de Vida
Procedimento: Computed Tomography

Undergo CT

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Magnetic Resonance Imaging

Undergo MRI

Outros nomes:
  • Ressonância magnética
  • Varredura de imagem por ressonância magnética
  • Imagem Médica, Ressonância Magnética / Ressonância Magnética Nuclear
  • SENHOR
  • Exame de ressonância magnética
  • Imagem NMR
  • Ressonância Magnética Nuclear
  • Ressonância Magnética (MRI)
  • ressonância magnética
  • Ressonância magnética (procedimento)
  • Ressonâncias magnéticas
  • RM estrutural
Outro: Questionnaire Administration

Ancillary studies

Procedimento: Bone Scan

Undergo bone scan

Outros nomes:
  • Cintilografia Óssea
Medicamento: Avelumab

Given IV

Outros nomes:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedimento: Biospecimen Collection

Undergo collection of blood and urine samples

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Experimental: Arm B (avelumab, cabozantinib)

Patients receive avelumab IV over 60 minutes on days 1 and 15 of each cycle and cabozantinib PO daily on days 1-28 of each cycle. Cycles repeat every 28 days for 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo bone scan at screening and undergo CT or MRI and biospecimen collection throughout the trial. Patients may undergo urine sample collection as clinically indicated.
Outro: Quality-of-Life Assessment

Ancillary studies

Outros nomes:
  • Avaliação da Qualidade de Vida
Procedimento: Computed Tomography

Undergo CT

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Magnetic Resonance Imaging

Undergo MRI

Outros nomes:
  • Ressonância magnética
  • Varredura de imagem por ressonância magnética
  • Imagem Médica, Ressonância Magnética / Ressonância Magnética Nuclear
  • SENHOR
  • Exame de ressonância magnética
  • Imagem NMR
  • Ressonância Magnética Nuclear
  • Ressonância Magnética (MRI)
  • ressonância magnética
  • Ressonância magnética (procedimento)
  • Ressonâncias magnéticas
  • RM estrutural
Outro: Questionnaire Administration

Ancillary studies

Medicamento: Cabozantinib S-malate

Given PO

Outros nomes:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • GG 184
Procedimento: Bone Scan

Undergo bone scan

Outros nomes:
  • Cintilografia Óssea
Medicamento: Avelumab

Given IV

Outros nomes:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedimento: Biospecimen Collection

Undergo collection of blood and urine samples

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Overall survival (OS)
Prazo: Time from randomization until death due to any cause, assessed up to 5 years

Subgroup analyses will be done using a stratified Cox model that includes the treatment arm assignment as an explanatory variable and a separate model will be generated for each level for the subgroup of interest.
Time from randomization until death due to any cause, assessed up to 5 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Progression free survival (PFS)
Prazo: Time from randomization until disease progression as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, assessed up to 5 years

A stratified Cox model will be used to compare the outcomes between the two treatment groups. The subgroup analyses will be done using a stratified Cox model that includes the treatment arm assignment as an explanatory variable and a separate model will be generated for each level for the subgroup of interest.
Time from randomization until disease progression as assessed by the treating physician using Response Evaluation Criteria in Solid Tumors (RECIST) or death due to any cause, assessed up to 5 years
Tumor response
Prazo: Up to 5 years

Will be defined as a complete response or partial response (PR) as measured with Immune-Modified RECIST. Will be compared between the arms using a Mantel-Haenszel test (that accounts for the randomization stratification factors) comparing the response rates between the two treatment arms. This analysis will only include patients who had a PR or stable disease (SD) response to first-line therapy. An additional analysis will be conducted using logistic regression analysis that includes treatment arm and any baseline variables that are imbalanced between the arms as explanatory variable.
Up to 5 years
Incidence of adverse events (AE)
Prazo: Up to 5 years

Will be assessed by Common Terminology Criteria for Adverse Events 5.0. Will be summarized with frequencies and relative frequencies. The maximum grade for an AE will be recorded for each patient by treatment arm. The number (percent) of patients that experience each observed adverse event will be summarized by treatment arm. In addition, the proportion of patients that experience a grade 3+, grade 4+, and grade 5 adverse event will be summarized as the number and percent of patients by treatment arm. The primary summary will be regardless of attribution. Will also do an analogous summary for the adverse events that were deemed at least possibly related to treatment.
Up to 5 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Shilpa Gupta, Alliance for Clinical Trials in Oncology

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

3 de junho de 2022

Conclusão Primária (Estimado)

15 de julho de 2029

Conclusão do estudo (Estimado)

15 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

22 de outubro de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de outubro de 2021

Primeira postagem (Real)

26 de outubro de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de outubro de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2021-11166
  • U10CA180821 (Concessão/Contrato do NIH dos EUA)
  • NCI-2021-11166 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • A032001 (Outro identificador: CTEP)
  • A032001 (Outro identificador: Alliance for Clinical Trials in Oncology)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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