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Het testen van de toevoeging van het antikankergeneesmiddel, cabozantinib, aan de gebruikelijke immunotherapiebehandeling, avelumab, bij patiënten met gemetastaseerde urotheelkanker, MAIN-CAV-onderzoek

23 oktober 2026 bijgewerkt door: National Cancer Institute (NCI)

MAIN-CAV: gerandomiseerde fase III-studie van onderhoudsbehandeling met cabozantinib en avelumab versus onderhoudstherapie met avelumab na eerstelijns op platina gebaseerde chemotherapie bij patiënten met gemetastaseerde urotheelkanker

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

654

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:
  • Beoordeling van de kwaliteit van leven
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies

Procedure: Bone Scan

Undergo bone scan

Andere namen:
  • Botscintigrafie
Geneesmiddel: Avelumab

Given IV

Andere namen:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedure: Biospecimen Collection

Undergo collection of blood and urine samples

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling
Experimenteel: 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.
Ander: Quality-of-Life Assessment

Ancillary studies

Andere namen:
  • Beoordeling van de kwaliteit van leven
Procedure: Computed Tomography

Undergo CT

Andere namen:
  • CT
  • KAT
  • CT-scan
  • Axiale computertomografie
  • Computergestuurde axiale tomografie
  • Computergestuurde tomografie
  • tomografie
  • Geautomatiseerde axiale tomografie (procedure)
  • Computertomografie (CT)-scan
  • Diagnostische kattencan
  • Diagnostisch CAT -scanservice type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andere namen:
  • MRI
  • Magnetische resonantie
  • Magnetic Resonance Imaging-scan
  • Medische beeldvorming, magnetische resonantie / nucleaire magnetische resonantie
  • DHR
  • MR-beeldvorming
  • MRI scan
  • NMR-beeldvorming
  • NMRI
  • Nucleaire magnetische resonantie beeldvorming
  • Magnetische resonantiebeeldvorming (MRI)
  • sMRI
  • Magnetische resonantiebeeldvorming (procedure)
  • MRI's
  • Structurele MRI
Ander: Questionnaire Administration

Ancillary studies

Geneesmiddel: Cabozantinib S-malate

Given PO

Andere namen:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
Procedure: Bone Scan

Undergo bone scan

Andere namen:
  • Botscintigrafie
Geneesmiddel: Avelumab

Given IV

Andere namen:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedure: Biospecimen Collection

Undergo collection of blood and urine samples

Andere namen:
  • Biologische monsterverzameling
  • Biospecimen verzameld
  • Specimenverzameling
  • Monsterverzameling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall survival (OS)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression free survival (PFS)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Cancer Institute (NCI)

Onderzoekers

  • Hoofdonderzoeker: Shilpa Gupta, Alliance for Clinical Trials in Oncology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

3 juni 2022

Primaire voltooiing (Geschat)

15 juli 2029

Studie voltooiing (Geschat)

15 juli 2029

Studieregistratiedata

Eerst ingediend

22 oktober 2021

Eerst ingediend dat voldeed aan de QC-criteria

22 oktober 2021

Eerst geplaatst (Werkelijk)

26 oktober 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

23 oktober 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • NCI-2021-11166
  • U10CA180821 (Subsidie/contract van de Amerikaanse NIH)
  • NCI-2021-11166 (Register-ID: CTRP (Clinical Trial Reporting Program))
  • A032001 (Andere identificatie: CTEP)
  • A032001 (Andere identificatie: Alliance for Clinical Trials in Oncology)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren