Testa tillägget av anticancerläkemedlet, Cabozantinib, till den vanliga immunterapibehandlingen, Avelumab, hos patienter med metastaserad urothelial cancer, MAIN-CAV-studie
MAIN-CAV: Randomiserad fas III-studie av underhåll av Cabozantinib och Avelumab vs underhåll av Avelumab efter första linjens platinabaserad kemoterapi hos patienter med metastaserad 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.
Studieöversikt
Status
Betingelser
- Avancerat urinblåsekarcinom
- Avancerat Ureter Urothelial Carcinoma
- Metastaserande urinblåsa-urothelial karcinom
- Metastaserande njurbäcken uroteliala karcinom
- Metastatisk Ureter Urothelial Carcinoma
- Metastaserande urinrörsurothelial karcinom
- Steg III Blåscancer AJCC v8
- Steg III njurbäckencancer AJCC v8
- Steg III Uretercancer AJCC v8
- Steg III Urethral Cancer AJCC v8
- Steg IV Blåscancer AJCC v8
- Steg IV njurbäckencancer AJCC v8
- Steg IV Uretercancer AJCC v8
- Steg IV Urethral Cancer AJCC v8
- Avancerat njurbäcken uroteliala karcinom
- Avancerat urinrörsurothelial karcinom
- Steg III njurbäcken och urinbäckencancer AJCC v8
- Steg IV njurbäcken och urinbäckencancer AJCC v8
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Arizona
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Phoenix, Arizona, Förenta staterna, 85054
- Mayo Clinic Hospital in Arizona
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California
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Auburn, California, Förenta staterna, 95602
- Sutter Auburn Faith Hospital
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Berkeley, California, Förenta staterna, 94704
- Alta Bates Summit Medical Center-Herrick Campus
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Fremont, California, Förenta staterna, 94538
- Palo Alto Medical Foundation-Fremont
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Modesto, California, Förenta staterna, 95355
- Memorial Medical Center
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Mountain View, California, Förenta staterna, 94040
- Palo Alto Medical Foundation-Camino Division
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Palo Alto, California, Förenta staterna, 94301
- Palo Alto Medical Foundation Health Care
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Roseville, California, Förenta staterna, 95661
- Sutter Roseville Medical Center
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Sacramento, California, Förenta staterna, 95816
- Sutter Medical Center Sacramento
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Comprehensive Cancer Center
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San Francisco, California, Förenta staterna, 94115
- California Pacific Medical Center-Pacific Campus
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Santa Cruz, California, Förenta staterna, 95065
- Palo Alto Medical Foundation-Santa Cruz
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Sunnyvale, California, Förenta staterna, 94086
- Palo Alto Medical Foundation-Sunnyvale
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Vallejo, California, Förenta staterna, 94589
- Sutter Solano Medical Center/Cancer Center
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Delaware
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Millville, Delaware, Förenta staterna, 19967
- Beebe South Coastal Health Campus
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Newark, Delaware, Förenta staterna, 19713
- Helen F Graham Cancer Center
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Newark, Delaware, Förenta staterna, 19713
- Medical Oncology Hematology Consultants PA
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Rehoboth Beach, Delaware, Förenta staterna, 19971
- Beebe Health Campus
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20010
- MedStar Washington Hospital Center
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Florida
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Gainesville, Florida, Förenta staterna, 32610
- UF Health Cancer Institute - Gainesville
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Jacksonville, Florida, Förenta staterna, 32224-9980
- Mayo Clinic in Florida
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Weston, Florida, Förenta staterna, 33331
- Cleveland Clinic-Weston
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Illinois
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Aurora, Illinois, Förenta staterna, 60504
- Rush-Copley Medical Center
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Barrington, Illinois, Förenta staterna, 60010
- Advocate Good Shepherd Hospital
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
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Chicago, Illinois, Förenta staterna, 60657
- Advocate Illinois Masonic Medical Center
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Chicago, Illinois, Förenta staterna, 60612
- Rush MD Anderson Cancer Center
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Crystal Lake, Illinois, Förenta staterna, 60014
- AMG Crystal Lake - Oncology
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Danville, Illinois, Förenta staterna, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Förenta staterna, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Downers Grove, Illinois, Förenta staterna, 60515
- Advocate Good Samaritan Hospital
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Elgin, Illinois, Förenta staterna, 60123
- Advocate Sherman Hospital
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Förenta staterna, 60134
- Northwestern Medicine Cancer Center Delnor
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Hazel Crest, Illinois, Förenta staterna, 60429
- Advocate South Suburban Hospital
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Förenta staterna, 60045
- Northwestern Medicine Lake Forest Hospital
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Libertyville, Illinois, Förenta staterna, 60048
- Condell Memorial Hospital
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Libertyville, Illinois, Förenta staterna, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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Oak Lawn, Illinois, Förenta staterna, 60453-2699
- Advocate Christ Medical Center
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Park Ridge, Illinois, Förenta staterna, 60068
- Advocate Lutheran General Hospital
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Förenta staterna, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Förenta staterna, 62269
- Memorial Hospital East
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Warrenville, Illinois, Förenta staterna, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Förenta staterna, 61571
- Illinois CancerCare - Washington
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Yorkville, Illinois, Förenta staterna, 60560
- Rush-Copley Healthcare Center
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Indiana
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Crown Point, Indiana, Förenta staterna, 46307
- Northwest Cancer Center - Crown Point
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Dyer, Indiana, Förenta staterna, 46311
- Northwest Oncology LLC
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Hobart, Indiana, Förenta staterna, 46342
- Northwest Cancer Center - Hobart
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Hobart, Indiana, Förenta staterna, 46342
- Saint Mary Medical Center
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Indianapolis, Indiana, Förenta staterna, 46312
- Saint Catherine Hospital
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Munster, Indiana, Förenta staterna, 46321
- The Community Hospital
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Munster, Indiana, Förenta staterna, 46321
- Women's Diagnostic Center - Munster
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Valparaiso, Indiana, Förenta staterna, 46383
- Northwest Cancer Center - Valparaiso
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
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Iowa City, Iowa, Förenta staterna, 52242
- University of Iowa/Holden Comprehensive Cancer Center
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40207
- Baptist Health Louisville
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Maine
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Augusta, Maine, Förenta staterna, 04330
- Harold Alfond Center for Cancer Care
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Maryland
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Bethesda, Maryland, Förenta staterna, 20892
- National Institutes of Health Clinical Center
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Massachusetts
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Worcester, Massachusetts, Förenta staterna, 01655
- UMass Memorial Medical Center - University Campus
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health Medical Center - Canton
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Chelsea, Michigan, Förenta staterna, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Förenta staterna, 48118
- Chelsea Hospital
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Clarkston, Michigan, Förenta staterna, 48346
- Hematology Oncology Consultants-Clarkston
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Clarkston, Michigan, Förenta staterna, 48346
- Newland Medical Associates-Clarkston
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Förenta staterna, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Förenta staterna, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Macomb, Michigan, Förenta staterna, 48044
- Henry Ford Saint John Hospital - Macomb Medical
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Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
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Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Förenta staterna, 48341
- Hope Cancer Center
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Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Pontiac, Michigan, Förenta staterna, 48341
- Michigan Healthcare Professionals Pontiac
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Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health IHA Medical Group-Alice Gustafson Center
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Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Förenta staterna, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Förenta staterna, 48106
- Huron Gastroenterology PC
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Minnesota
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Bemidji, Minnesota, Förenta staterna, 56601
- Sanford Joe Lueken Cancer Center
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Minneapolis, Minnesota, Förenta staterna, 55415
- Hennepin County Medical Center
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
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Saint Cloud, Minnesota, Förenta staterna, 56303
- Coborn Cancer Center at Saint Cloud Hospital
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Willmar, Minnesota, Förenta staterna, 56201
- Rice Memorial Hospital
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Missouri
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Förenta staterna, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Columbia, Missouri, Förenta staterna, 65212
- MU Health - University Hospital/Ellis Fischel Cancer Center
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Creve Coeur, Missouri, Förenta staterna, 63141
- Siteman Cancer Center at West County Hospital
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Kansas City, Missouri, Förenta staterna, 64111
- Saint Luke's Hospital of Kansas City
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Lee's Summit, Missouri, Förenta staterna, 64086
- Saint Luke's East - Lee's Summit
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St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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St Louis, Missouri, Förenta staterna, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Förenta staterna, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
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New Hampshire
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Concord, New Hampshire, Förenta staterna, 03301
- New Hampshire Oncology Hematology PA-Concord
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Manchester, New Hampshire, Förenta staterna, 03103
- Solinsky Center for Cancer Care
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New Jersey
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Basking Ridge, New Jersey, Förenta staterna, 07920
- Memorial Sloan Kettering Basking Ridge
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
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Middletown, New Jersey, Förenta staterna, 07748
- Memorial Sloan Kettering Monmouth
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Montvale, New Jersey, Förenta staterna, 07645
- Memorial Sloan Kettering Bergen
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Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
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Paterson, New Jersey, Förenta staterna, 07503
- Saint Joseph's Regional Medical Center
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Summit, New Jersey, Förenta staterna, 07902
- Overlook Hospital
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New Mexico
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Albuquerque, New Mexico, Förenta staterna, 87106
- University of New Mexico Cancer Center
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Las Cruces, New Mexico, Förenta staterna, 88011
- Memorial Medical Center-Las Cruces
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New York
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Commack, New York, Förenta staterna, 11725
- Memorial Sloan Kettering Commack
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Elmira, New York, Förenta staterna, 14905
- Arnot Ogden Medical Center/Falck Cancer Center
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Glens Falls, New York, Förenta staterna, 12801
- Glens Falls Hospital
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Harrison, New York, Förenta staterna, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center
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Oswego, New York, Förenta staterna, 13126
- Upstate Cancer Center at Oswego
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Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University Medical Center
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Syracuse, New York, Förenta staterna, 13210
- State University of New York Upstate Medical University
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Syracuse, New York, Förenta staterna, 13215
- SUNY Upstate Medical Center-Community Campus
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Uniondale, New York, Förenta staterna, 11553
- Memorial Sloan Kettering Nassau
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Verona, New York, Förenta staterna, 13478
- Upstate Cancer Center at Verona
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28203
- Carolinas Medical Center/Levine Cancer Institute
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Charlotte, North Carolina, Förenta staterna, 28262
- Atrium Health University City/LCI-University
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Charlotte, North Carolina, Förenta staterna, 28211
- Levine Cancer Institute-SouthPark
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Charlotte, North Carolina, Förenta staterna, 28277
- Levine Cancer Institute-Ballantyne
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Clinton, North Carolina, Förenta staterna, 28328
- Southeastern Medical Oncology Center-Clinton
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Concord, North Carolina, Förenta staterna, 28025
- Atrium Health Cabarrus/LCI-Concord
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Goldsboro, North Carolina, Förenta staterna, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Förenta staterna, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Lincolnton, North Carolina, Förenta staterna, 28092
- Atrium Health Lincoln/LCI-Lincolnton
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Shelby, North Carolina, Förenta staterna, 28150
- Atrium Health Cleveland/LCI-Cleveland
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501
- Sanford Bismarck Medical Center
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Förenta staterna, 58122
- Sanford Broadway Medical Center
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Ohio
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Akron, Ohio, Förenta staterna, 44307
- Cleveland Clinic Akron General
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Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
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Cleveland, Ohio, Förenta staterna, 44111
- Cleveland Clinic Cancer Center/Fairview Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Förenta staterna, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Förenta staterna, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
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Mansfield, Ohio, Förenta staterna, 44906
- Cleveland Clinic Cancer Center Mansfield
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Mayfield Heights, Ohio, Förenta staterna, 44124
- Hillcrest Hospital Cancer Center
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Sandusky, Ohio, Förenta staterna, 44870
- North Coast Cancer Care
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Strongsville, Ohio, Förenta staterna, 44136
- Cleveland Clinic Cancer Center Strongsville
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Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Centers-Toledo
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Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
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Warrensville Heights, Ohio, Förenta staterna, 44122
- South Pointe Hospital
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Wooster, Ohio, Förenta staterna, 44691
- Cleveland Clinic Wooster Family Health and Surgery Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Förenta staterna, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Gresham, Oregon, Förenta staterna, 97030
- Legacy Mount Hood Medical Center
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Portland, Oregon, Förenta staterna, 97210
- Legacy Good Samaritan Hospital and Medical Center
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Tualatin, Oregon, Förenta staterna, 97062
- Legacy Meridian Park Hospital
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Pennsylvania
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Allentown, Pennsylvania, Förenta staterna, 18103
- Lehigh Valley Hospital-Cedar Crest
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Bethlehem, Pennsylvania, Förenta staterna, 18017
- Lehigh Valley Hospital - Muhlenberg
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Harrisburg, Pennsylvania, Förenta staterna, 17111
- Penn State Health Medical Group - Andrews Patel Hematology/Oncology East
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Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19148
- Jefferson Methodist Hospital
-
-
South Carolina
-
Boiling Springs, South Carolina, Förenta staterna, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Charleston, South Carolina, Förenta staterna, 29425
- Medical University of South Carolina
-
Easley, South Carolina, Förenta staterna, 29640
- Prisma Health Cancer Institute - Easley
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Förenta staterna, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Greenville Memorial Hospital
-
Greer, South Carolina, Förenta staterna, 29650
- Prisma Health Cancer Institute - Greer
-
Rock Hill, South Carolina, Förenta staterna, 29732
- Levine Cancer Institute-Rock Hill
-
Seneca, South Carolina, Förenta staterna, 29672
- Prisma Health Cancer Institute - Seneca
-
-
South Dakota
-
Aberdeen, South Dakota, Förenta staterna, 57401
- Avera Cancer Institute-Aberdeen
-
Rapid City, South Dakota, Förenta staterna, 57701
- Rapid City Regional Hospital
-
Sioux Falls, South Dakota, Förenta staterna, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Förenta staterna, 57117-5134
- Sanford USD Medical Center - Sioux Falls
-
Sioux Falls, South Dakota, Förenta staterna, 57104
- Sanford Cancer Center Oncology Clinic
-
Yankton, South Dakota, Förenta staterna, 57078
- Avera Cancer Institute at Yankton
-
-
Tennessee
-
Alcoa, Tennessee, Förenta staterna, 37701
- University Cancer Specialists - Alcoa
-
Knoxville, Tennessee, Förenta staterna, 37920
- University of Tennessee - Knoxville
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Dallas, Texas, Förenta staterna, 75237
- UT Southwestern Simmons Cancer Center - RedBird
-
Fort Worth, Texas, Förenta staterna, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Richardson, Texas, Förenta staterna, 75080
- UT Southwestern Clinical Center at Richardson/Plano
-
-
Virginia
-
Mechanicsville, Virginia, Förenta staterna, 23116
- Bon Secours Memorial Regional Medical Center
-
Midlothian, Virginia, Förenta staterna, 23114
- Bon Secours Saint Francis Medical Center
-
Richmond, Virginia, Förenta staterna, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Förenta staterna, 23229
- Virginia Cancer Institute
-
Richmond, Virginia, Förenta staterna, 23226
- Bon Secours Saint Mary's Hospital
-
Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
-
South Hill, Virginia, Förenta staterna, 23970
- VCU Community Memorial Health Center
-
Winchester, Virginia, Förenta staterna, 22601
- Shenandoah Oncology PC
-
-
Washington
-
Renton, Washington, Förenta staterna, 98055
- Valley Medical Center
-
Vancouver, Washington, Förenta staterna, 98686
- Legacy Salmon Creek Hospital
-
Vancouver, Washington, Förenta staterna, 98684
- Legacy Cancer Institute Medical Oncology and Day Treatment
-
-
West Virginia
-
Charleston, West Virginia, Förenta staterna, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
-
-
Wisconsin
-
Burlington, Wisconsin, Förenta staterna, 53105
- Aurora Cancer Care-Southern Lakes VLCC
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Medical Center-EC Cancer Center
-
Germantown, Wisconsin, Förenta staterna, 53022
- Aurora Health Care Germantown Health Center
-
Grafton, Wisconsin, Förenta staterna, 53024
- Aurora Cancer Care-Grafton
-
Green Bay, Wisconsin, Förenta staterna, 54311
- Aurora BayCare Medical Center
-
Kenosha, Wisconsin, Förenta staterna, 53142
- Aurora Cancer Care-Kenosha South
-
Marinette, Wisconsin, Förenta staterna, 54143
- Aurora Bay Area Medical Group-Marinette
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Menomonee Falls, Wisconsin, Förenta staterna, 53051
- Froedtert Menomonee Falls Hospital
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
-
Milwaukee, Wisconsin, Förenta staterna, 53209
- Aurora Cancer Care-Milwaukee
-
Milwaukee, Wisconsin, Förenta staterna, 53215
- Aurora Saint Luke's Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53233
- Aurora Sinai Medical Center
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
-
Mukwonago, Wisconsin, Förenta staterna, 53149
- ProHealth D N Greenwald Center
-
New Richmond, Wisconsin, Förenta staterna, 54017
- Cancer Center of Western Wisconsin
-
Oak Creek, Wisconsin, Förenta staterna, 53154
- Drexel Town Square Health Center
-
Oconomowoc, Wisconsin, Förenta staterna, 53066
- ProHealth Oconomowoc Memorial Hospital
-
Oshkosh, Wisconsin, Förenta staterna, 54904
- Vince Lombardi Cancer Clinic - Oshkosh
-
Racine, Wisconsin, Förenta staterna, 53406
- Aurora Cancer Care-Racine
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- Vince Lombardi Cancer Clinic-Sheboygan
-
Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Summit, Wisconsin, Förenta staterna, 53066
- Aurora Medical Center in Summit
-
Two Rivers, Wisconsin, Förenta staterna, 54241
- Vince Lombardi Cancer Clinic-Two Rivers
-
Waukesha, Wisconsin, Förenta staterna, 53188
- UW Cancer Center at ProHealth Care
-
Waukesha, Wisconsin, Förenta staterna, 53188
- ProHealth Waukesha Memorial Hospital
-
Wauwatosa, Wisconsin, Förenta staterna, 53226
- Aurora Cancer Care-Milwaukee West
-
West Allis, Wisconsin, Förenta staterna, 53227
- Aurora West Allis Medical Center
-
West Bend, Wisconsin, Förenta staterna, 53095
- Froedtert West Bend Hospital/Kraemer Cancer Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
-
-
-
-
Alberta
-
Edmonton, Alberta, Kanada, T6G 1Z2
- Cross Cancer Institute
-
-
Ontario
-
Toronto, Ontario, Kanada, M5G 2M9
- University Health Network-Princess Margaret Hospital
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
-
Saskatoon, Saskatchewan, Kanada, S7N 4H4
- Saskatoon Cancer Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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. |
Ancillary studies
Andra namn:
Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Ancillary studies Undergo bone scan
Andra namn:
Given IV
Andra namn:
Undergo collection of blood and urine samples
Andra namn:
|
|
Experimentell: 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. |
Ancillary studies
Andra namn:
Undergo CT
Andra namn:
Undergo MRI
Andra namn:
Ancillary studies Given PO
Andra namn:
Undergo bone scan
Andra namn:
Given IV
Andra namn:
Undergo collection of blood and urine samples
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival (OS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression free survival (PFS)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Shilpa Gupta, Alliance for Clinical Trials in Oncology
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Manliga urogenitala sjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Urologiska neoplasmer
- Ureterala sjukdomar
- Sjukdomar i urinblåsan
- Urethral sjukdomar
- Ureterala neoplasmer
- Neoplasmer i urinblåsan
- Urethral neoplasmer
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Kemitekniker, analytiska
- Spektrumanalys
- Provhantering
- Magnetresonansspektroskopi
- avelumab
- cabozantinib
Andra studie-ID-nummer
- NCI-2021-11166
- U10CA180821 (U.S.S. NIH-anslag/kontrakt)
- NCI-2021-11166 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- A032001 (Annan identifierare: CTEP)
- A032001 (Annan identifierare: Alliance for Clinical Trials in Oncology)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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
Läkemedels- och apparatinformation, studiedokument
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