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Test dell'aggiunta del farmaco antitumorale, Cabozantinib, al consueto trattamento immunoterapico, Avelumab, in pazienti con carcinoma uroteliale metastatico, studio MAIN-CAV

11 novembre 2026 aggiornato da: National Cancer Institute (NCI)

MAIN-CAV: studio di fase III randomizzato di mantenimento con cabozantinib e avelumab rispetto al mantenimento con avelumab dopo chemioterapia di prima linea a base di platino in pazienti con carcinoma uroteliale metastatico

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.

Panoramica dello studio

Stato

Stato

Indica lo stato di reclutamento attuale o lo stato di accesso ampliato.
Attivo, non reclutante

Condizioni

Condizioni

La malattia, il disturbo, la sindrome, la malattia o la lesione oggetto di studio. Su ClinicalTrials.gov, le condizioni possono includere anche altri problemi relativi alla salute, come la durata della vita, la qualità della vita e i rischi per la salute.

Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.

Descrizione dettagliata

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

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

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

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

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

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

QUALITY OF LIFE (QOL) OBJECTIVES:

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

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

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

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

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

OUTLINE: Patients are randomized to 1 of 2 arms.

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

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

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

Tipo di studio

Tipo di studio

Descrive la natura di uno studio clinico. I tipi di studio includono studi interventistici (chiamati anche studi clinici), studi osservazionali (compresi i registri dei pazienti) e accesso allargato.
Interventistico

Iscrizione (Stimato)

Iscrizione

Il numero di partecipanti a uno studio clinico. L'iscrizione "anticipata" è il numero target di partecipanti di cui i ricercatori hanno bisogno per lo studio.
654

Fase

Fase

La fase di una sperimentazione clinica che studia un farmaco o un prodotto biologico, sulla base delle definizioni sviluppate dalla Food and Drug Administration (FDA) statunitense. La fase si basa sull'obiettivo dello studio, sul numero di partecipanti e su altre caratteristiche. Ci sono cinque fasi: Early Phase 1 (precedentemente indicata come Fase 0), Phase 1, Phase 2, Phase 3 e Phase 4. Not Applicable è usato per descrivere sperimentazioni senza fasi definite dalla FDA, incluse sperimentazioni di dispositivi o interventi comportamentali.
  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Criteri di ammissibilità

I requisiti chiave che devono soddisfare le persone che vogliono partecipare a uno studio clinico o le caratteristiche che devono avere. I criteri di ammissibilità sono costituiti sia da criteri di inclusione (necessari a una persona per partecipare allo studio) sia da criteri di esclusione (che impediscono a una persona di partecipare). I tipi di criteri di ammissibilità includono se uno studio accetta volontari sani, ha requisiti di età o gruppo di età o è limitato dal sesso.

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm

Gruppo di partecipanti / Arm

Un gruppo o sottogruppo di partecipanti a uno studio clinico che riceve un intervento/trattamento specifico o nessun intervento, secondo il protocollo dello studio.
Intervento / Trattamento

Intervento / Trattamento

Un processo o un'azione che è al centro di uno studio clinico. Gli interventi includono farmaci, dispositivi medici, procedure, vaccini e altri prodotti sperimentali o già disponibili. Gli interventi possono anche includere approcci non invasivi, come l'educazione o la modifica della dieta e dell'esercizio fisico.
Comparatore attivo: 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.
Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:
  • Valutazione della qualità della vita
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Procedura: Bone Scan

Undergo bone scan

Altri nomi:
  • Scintigrafia ossea
Droga: Avelumab

Given IV

Altri nomi:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedura: Biospecimen Collection

Undergo collection of blood and urine samples

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Sperimentale: 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.
Altro: Quality-of-Life Assessment

Ancillary studies

Altri nomi:
  • Valutazione della qualità della vita
Procedura: Computed Tomography

Undergo CT

Altri nomi:
  • CT
  • GATTO
  • TAC
  • Tomografia assiale computerizzata
  • Tomografia computerizzata
  • tomografia
  • Tomografia assiale computerizzata (procedura)
  • Scansione tomografia computerizzata (CT).
  • Scansione CAT diagnostica
  • Tipo di servizio di scansione CAT diagnostica
Procedura: Magnetic Resonance Imaging

Undergo MRI

Altri nomi:
  • Risonanza magnetica
  • Scansione di immagini a risonanza magnetica
  • Imaging medico, risonanza magnetica/risonanza magnetica nucleare
  • SIG
  • Imaging RM
  • Scansione MRI
  • Imaging NMR
  • RMN
  • Risonanza Magnetica Nucleare
  • Imaging a risonanza magnetica (MRI)
  • sMRI
  • Imaging a risonanza magnetica (procedura)
  • RM strutturale
Altro: Questionnaire Administration

Ancillary studies

Droga: Cabozantinib S-malate

Given PO

Altri nomi:
  • BMS-907351
  • Cabometix
  • Cometriq
  • XL-184
  • XL184
  • XL 184
Procedura: Bone Scan

Undergo bone scan

Altri nomi:
  • Scintigrafia ossea
Droga: Avelumab

Given IV

Altri nomi:
  • Bavencio
  • MSB-0010718C
  • MSB0010718C
Procedura: Biospecimen Collection

Undergo collection of blood and urine samples

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato primarie

Nel protocollo di uno studio clinico, la misura dell'esito pianificato più importante per valutare l'effetto di un intervento/trattamento. La maggior parte degli studi clinici ha una misura di esito primaria, ma alcuni ne hanno più di una.
Misura del risultato
Misura Descrizione
Lasso di tempo
Overall survival (OS)
Lasso di tempo: 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

Misure di risultato secondarie

Misure di risultato secondarie

Nel protocollo di uno studio clinico, una misura dell'esito pianificato che non è importante quanto la misura dell'esito primario per valutare l'effetto di un intervento ma è comunque di interesse. La maggior parte degli studi clinici ha più di una misura di esito secondaria.
Misura del risultato
Misura Descrizione
Lasso di tempo
Progression free survival (PFS)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Sponsor

L'organizzazione o la persona che avvia lo studio e che ha autorità e controllo sullo studio.
National Cancer Institute (NCI)

Investigatori

Investigatori

Un ricercatore coinvolto in uno studio clinico. I termini correlati includono il ricercatore principale del sito, il ricercatore secondario del sito, il presidente dello studio, il direttore dello studio e il ricercatore principale dello studio.
  • Investigatore principale: Shilpa Gupta, Alliance for Clinical Trials in Oncology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

Inizio studio

La data effettiva in cui il primo partecipante è stato arruolato in uno studio clinico. La data di inizio dello studio "prevista" è la data che i ricercatori pensano sarà la data di inizio dello studio.
3 giugno 2022

Completamento primario (Stimato)

Completamento primario

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento per raccogliere i dati finali per la misura dell'esito primario. Il fatto che lo studio clinico sia terminato secondo il protocollo o sia stato interrotto non influisce su questa data. Per gli studi clinici con più di una misura di esito primario con diverse date di completamento, questo termine si riferisce alla data in cui la raccolta dei dati è completata per tutte le misure di esito primario. La data di completamento principale "prevista" è la data che i ricercatori ritengono sarà la data di completamento principale per lo studio.
15 luglio 2029

Completamento dello studio (Stimato)

Completamento dello studio

La data in cui l'ultimo partecipante a uno studio clinico è stato esaminato o ha ricevuto un intervento/trattamento per raccogliere i dati finali per le misure di esito primarie, le misure di esito secondarie e gli eventi avversi (ovvero l'ultima visita dell'ultimo partecipante). La data di completamento dello studio "prevista" è la data che i ricercatori ritengono sarà la data di completamento dello studio.
15 luglio 2029

Date di iscrizione allo studio

Primo inviato

Primo inviato

La data in cui lo sponsor o il ricercatore dello studio ha inviato per la prima volta un record di studio a ClinicalTrials.gov. In genere c'è un ritardo di alcuni giorni tra la prima data di invio e la disponibilità del record su ClinicalTrials.gov (la prima data di invio).
22 ottobre 2021

Primo inviato che soddisfa i criteri di controllo qualità

Primo inviato che soddisfa i criteri di controllo qualità

La data in cui lo sponsor dello studio o il ricercatore invia per la prima volta un record di studio che è coerente con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). Lo sponsor o lo sperimentatore potrebbe dover rivedere e inviare un record di studio una o più volte prima che i criteri di revisione QC di NLM siano soddisfatti. È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
22 ottobre 2021

Primo Inserito (Effettivo)

Primo Inserito

La data in cui il record dello studio è stato disponibile per la prima volta su ClinicalTrials.gov dopo la conclusione della revisione del controllo di qualità (QC) della National Library of Medicine (NLM). In genere c'è un ritardo di alcuni giorni tra la data in cui lo sponsor dello studio o lo sperimentatore ha presentato il record dello studio e la prima data pubblicata.
26 ottobre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

Ultimo aggiornamento pubblicato

La data più recente in cui le modifiche al record di uno studio sono state rese disponibili su ClinicalTrials.gov. Potrebbe esserci un ritardo tra il momento in cui le modifiche sono state inviate a ClinicalTrials.gov dallo sponsor o dallo sperimentatore dello studio (data di invio dell'ultimo aggiornamento) e la data di pubblicazione dell'ultimo aggiornamento.
12 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

Ultimo aggiornamento inviato che soddisfa i criteri QC

La data più recente in cui lo sponsor dello studio o il ricercatore ha presentato modifiche a un record di studio che sono coerenti con i criteri di revisione del controllo di qualità (QC) della National Library of Medicine (NLM). È responsabilità dello sponsor o dello sperimentatore garantire che il record dello studio sia coerente con i criteri di revisione QC NLM.
11 novembre 2026

Ultimo verificato

Ultimo verificato

La data più recente in cui lo sponsor dello studio o il ricercatore ha confermato che le informazioni su uno studio clinico su ClinicalTrials.gov sono accurate e aggiornate. Se uno studio con stato di reclutamento di reclutamento; non ancora reclutamento; o attivo, non reclutamento non è stato confermato negli ultimi 2 anni, lo stato di reclutamento dello studio viene mostrato come sconosciuto.
1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

Altri numeri di identificazione dello studio

Identificatori o numeri ID diversi dal numero NCT assegnati a uno studio clinico dallo sponsor, dai finanziatori o da altri dello studio. Questi numeri possono includere identificatori univoci di altri registri di sperimentazione e numeri di sovvenzioni del National Institutes of Health.
  • NCI-2021-11166
  • U10CA180821 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2021-11166 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • A032001 (Altro identificatore: CTEP)
  • A032001 (Altro identificatore: Alliance for Clinical Trials in Oncology)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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