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Afprøvning af tilføjelsen af ​​anti-cancer-lægemidlet, Cabozantinib, til den sædvanlige immunterapibehandling, Avelumab, hos patienter med metastatisk urothelial cancer, MAIN-CAV-undersøgelse

23. oktober 2026 opdateret af: National Cancer Institute (NCI)

MAIN-CAV: Fase III randomiseret undersøgelse af vedligeholdelses Cabozantinib og Avelumab vs vedligeholdelse Avelumab efter førstelinje platinbaseret kemoterapi hos patienter med metastatisk urothelial cancer

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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

654

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Andet: Quality-of-Life Assessment

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Andet: Questionnaire Administration

Ancillary studies

Procedure: Bone Scan

Undergo bone scan

Andre navne:
  • Knoglescintigrafi
Medicin: Avelumab

Given IV

Andre navne:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
  • MSB 0010718C
Procedure: Biospecimen Collection

Undergo collection of blood and urine samples

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion
Eksperimentel: 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.
Andet: Quality-of-Life Assessment

Ancillary studies

Andre navne:
  • Livskvalitetsvurdering
Procedure: Computed Tomography

Undergo CT

Andre navne:
  • CT
  • KAT
  • CAT-scanning
  • Beregnet aksial tomografi
  • Computerstyret aksial tomografi
  • Computerstyret tomografi
  • CT-scanning
  • tomografi
  • Computerstyret aksial tomografi (procedure)
  • Computerstyret tomografi (CT) scanning
  • Diagnostisk CAT -scanning
  • Diagnostic CAT Scan Service Type
Procedure: Magnetic Resonance Imaging

Undergo MRI

Andre navne:
  • MR
  • Magnetisk resonans
  • Magnetisk resonansbilledscanning
  • Medicinsk billeddannelse, magnetisk resonans / kernemagnetisk resonans
  • HR
  • MR billeddannelse
  • MR-scanning
  • NMR billeddannelse
  • NMRI
  • Kernemagnetisk resonansbilleddannelse
  • Magnetisk resonansbilleddannelse (MRI)
  • sMRI
  • Magnetisk resonansbilleddannelse (procedure)
  • MRI'er
  • Strukturel MR
Andet: Questionnaire Administration

Ancillary studies

Medicin: Cabozantinib S-malate

Given PO

Andre navne:
  • BMS-907351
  • Cabometyx
  • Cometriq
  • XL-184
  • XL184
  • XL 184
Procedure: Bone Scan

Undergo bone scan

Andre navne:
  • Knoglescintigrafi
Medicin: Avelumab

Given IV

Andre navne:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
  • MSB 0010718C
Procedure: Biospecimen Collection

Undergo collection of blood and urine samples

Andre navne:
  • Biologisk prøvesamling
  • Bioprøve indsamlet
  • Prøvesamling
  • Prøvekollektion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall survival (OS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression free survival (PFS)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Shilpa Gupta, Alliance for Clinical Trials in Oncology

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juni 2022

Primær færdiggørelse (Anslået)

15. juli 2029

Studieafslutning (Anslået)

15. juli 2029

Datoer for studieregistrering

Først indsendt

22. oktober 2021

Først indsendt, der opfyldte QC-kriterier

22. oktober 2021

Først opslået (Faktiske)

26. oktober 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NCI-2021-11166
  • U10CA180821 (U.S. NIH-bevilling/kontrakt)
  • NCI-2021-11166 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • A032001 (Anden identifikator: CTEP)
  • A032001 (Anden identifikator: Alliance for Clinical Trials in Oncology)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner