Test af cabozantinib med eller uden atezolizumab hos patienter med avanceret papillær nyrekræft, PAPMET2-forsøg
Et fase II randomiseret forsøg med Cabozantinib (NSC #761968) med eller uden Atezolizumab (NSC #783608) hos patienter med avanceret papillær nyrecellecarcinom (PAPMET2)
This phase II trial compares the effect of atezolizumab in combination with usual treatment with cabozantinib to cabozantinib alone in patients with papillary renal cell carcinoma that has spread from where it first started (primary site) to other places in the body (metastatic). Papillary renal cell carcinoma (PRCC) is a type of kidney cancer that forms in the lining of the tiny tubes in the kidney that return filtered substances that the body needs back to the blood and remove extra fluid and waste as urine. Most papillary tumors look like long, thin finger-like growths under a microscope. It is also called papillary kidney cancer or PRCC. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the tumor and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals tumor cells to multiply and may also prevent the growth of new blood vessels that tumors need to grow. By these actions it may help slow or stop the spread of tumor cells. Combination therapy with atezolizumab and cabozantinib may shrink the tumor and allow a longer survival time in patients with metastatic renal cell carcinoma.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVE:
I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib (cabozantinib S-malate) with atezolizumab versus cabozantinib alone.
SECONDARY OBJECTIVES:
I. To compare overall survival in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
II. To compare Response Evaluation Criteria in Solid Tumors (RECIST) objective response rate (confirmed and unconfirmed, complete and partial response) in participants with mPRCC randomized to cabozantinib with atezolizumab versus cabozantinib alone.
III. To evaluate the quantitative and qualitive adverse events observed in each treatment arm.
BANKING OBJECTIVE:
I. To bank biospecimens for future correlative studies.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive cabozantinib S-malate orally (PO) once daily (QD) on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
ARM II: Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab intravenously (IV) over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for up to 5 years.
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Gilbert, Arizona, Forenede Stater, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Forenede Stater, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72205
- University of Arkansas for Medical Sciences
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California
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Anaheim, California, Forenede Stater, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Forenede Stater, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Forenede Stater, 90706
- Kaiser Permanente-Bellflower
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Duarte, California, Forenede Stater, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Forenede Stater, 94568
- Epic Care-Dublin
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Emeryville, California, Forenede Stater, 94608
- Epic Care Partners in Cancer Care
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Fontana, California, Forenede Stater, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Forenede Stater, 90710
- Kaiser Permanente South Bay
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Irvine, California, Forenede Stater, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Forenede Stater, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Forenede Stater, 90034
- Kaiser Permanente West Los Angeles
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Martinez, California, Forenede Stater, 94553-3156
- Contra Costa Regional Medical Center
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Ontario, California, Forenede Stater, 91761
- Kaiser Permanente-Ontario
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Panorama City, California, Forenede Stater, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Forenede Stater, 92505
- Kaiser Permanente-Riverside
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Sacramento, California, Forenede Stater, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Forenede Stater, 92120
- Kaiser Permanente-San Diego Zion
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San Marcos, California, Forenede Stater, 92078
- Kaiser Permanente-San Marcos
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Walnut Creek, California, Forenede Stater, 94597
- Epic Care Cyberknife Center
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Woodland Hills, California, Forenede Stater, 91367
- Kaiser Permanente-Woodland Hills
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District of Columbia
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Washington D.C., District of Columbia, Forenede Stater, 20007
- MedStar Georgetown University Hospital
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Idaho
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Boise, Idaho, Forenede Stater, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Forenede Stater, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Forenede Stater, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Forenede Stater, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Forenede Stater, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Forenede Stater, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Forenede Stater, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Forenede Stater, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Forenede Stater, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Forenede Stater, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Forenede Stater, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Forenede Stater, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Forenede Stater, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Forenede Stater, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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Danville, Illinois, Forenede Stater, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Forenede Stater, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Forenede Stater, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Forenede Stater, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Forenede Stater, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Forenede Stater, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Forenede Stater, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Forenede Stater, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Forenede Stater, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Forenede Stater, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Forenede Stater, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Forenede Stater, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Forenede Stater, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Forenede Stater, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Forenede Stater, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Forenede Stater, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Forenede Stater, 62269
- Cancer Care Center of O'Fallon
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Orland Park, Illinois, Forenede Stater, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Forenede Stater, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Forenede Stater, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Forenede Stater, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Forenede Stater, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Forenede Stater, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Forenede Stater, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Forenede Stater, 62269
- Memorial Hospital East
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Springfield, Illinois, Forenede Stater, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic
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Springfield, Illinois, Forenede Stater, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Forenede Stater, 61801
- Carle Cancer Center
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Warrenville, Illinois, Forenede Stater, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Forenede Stater, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Forenede Stater, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Forenede Stater, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Forenede Stater, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Forenede Stater, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Forenede Stater, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Forenede Stater, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Forenede Stater, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Forenede Stater, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Forenede Stater, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Forenede Stater, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Forenede Stater, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Louisiana
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Metairie, Louisiana, Forenede Stater, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Forenede Stater, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Metairie, Louisiana, Forenede Stater, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Forenede Stater, 70112
- University Medical Center New Orleans
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New Orleans, Louisiana, Forenede Stater, 70115
- Touro Infirmary
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Forenede Stater, 49017
- Bronson Battle Creek
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Brighton, Michigan, Forenede Stater, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Forenede Stater, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Forenede Stater, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Forenede Stater, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Forenede Stater, 48723
- Caro Cancer Center
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Chelsea, Michigan, Forenede Stater, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Forenede Stater, 48118
- Chelsea Hospital
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Detroit, Michigan, Forenede Stater, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, Forenede Stater, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Forenede Stater, 48503
- Hurley Medical Center
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Flint, Michigan, Forenede Stater, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Forenede Stater, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Forenede Stater, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Forenede Stater, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Forenede Stater, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Forenede Stater, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Forenede Stater, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Forenede Stater, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Forenede Stater, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Marlette, Michigan, Forenede Stater, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Muskegon, Michigan, Forenede Stater, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Forenede Stater, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Forenede Stater, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Forenede Stater, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw, Michigan, Forenede Stater, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Forenede Stater, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Forenede Stater, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Tawas City, Michigan, Forenede Stater, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Forenede Stater, 49684
- Munson Medical Center
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West Branch, Michigan, Forenede Stater, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Forenede Stater, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Forenede Stater, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Forenede Stater, 48106
- Huron Gastroenterology PC
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Minnesota
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Coon Rapids, Minnesota, Forenede Stater, 55433
- Mercy Hospital
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Edina, Minnesota, Forenede Stater, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Forenede Stater, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Forenede Stater, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Forenede Stater, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Forenede Stater, 55101
- Regions Hospital
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Saint Paul, Minnesota, Forenede Stater, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Forenede Stater, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Forenede Stater, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Forenede Stater, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Forenede Stater, 63141
- Siteman Cancer Center at West County Hospital
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Farmington, Missouri, Forenede Stater, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Forenede Stater, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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St Louis, Missouri, Forenede Stater, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Forenede Stater, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Forenede Stater, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Forenede Stater, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Forenede Stater, 63128
- Mercy Hospital South
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Sullivan, Missouri, Forenede Stater, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Forenede Stater, 59711
- Community Hospital of Anaconda
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Billings, Montana, Forenede Stater, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Forenede Stater, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Forenede Stater, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Forenede Stater, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Forenede Stater, 59901
- Logan Health Medical Center
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Missoula, Montana, Forenede Stater, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Forenede Stater, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Hackensack, New Jersey, Forenede Stater, 07601
- Hackensack University Medical Center
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North Carolina
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Cary, North Carolina, Forenede Stater, 27518
- Duke Cancer Center Cary
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Clinton, North Carolina, Forenede Stater, 28328
- Southeastern Medical Oncology Center-Clinton
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Goldsboro, North Carolina, Forenede Stater, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Forenede Stater, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Pinehurst, North Carolina, Forenede Stater, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Raleigh, North Carolina, Forenede Stater, 27609
- Duke Cancer Center Raleigh
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Ohio
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Avon, Ohio, Forenede Stater, 44011
- UH Seidman Cancer Center at UH Avon Health Center
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Beachwood, Ohio, Forenede Stater, 44122
- UHHS-Chagrin Highlands Medical Center
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Centerville, Ohio, Forenede Stater, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Forenede Stater, 44106
- Case Western Reserve University
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Dayton, Ohio, Forenede Stater, 45409
- Miami Valley Hospital
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Dayton, Ohio, Forenede Stater, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Forenede Stater, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Forenede Stater, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Forenede Stater, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Forenede Stater, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Forenede Stater, 45429
- Kettering Medical Center
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Troy, Ohio, Forenede Stater, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Forenede Stater, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Newberg, Oregon, Forenede Stater, 97132
- Providence Newberg Medical Center
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Ontario, Oregon, Forenede Stater, 97914
- Saint Alphonsus Cancer Care Center-Ontario
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Oregon City, Oregon, Forenede Stater, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Forenede Stater, 97239
- Oregon Health and Science University
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Portland, Oregon, Forenede Stater, 97213
- Providence Portland Medical Center
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Portland, Oregon, Forenede Stater, 97225
- Providence Saint Vincent Medical Center
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Texas
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Dallas, Texas, Forenede Stater, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Forenede Stater, 75237
- UT Southwestern Simmons Cancer Center - RedBird
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Fort Worth, Texas, Forenede Stater, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
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Richardson, Texas, Forenede Stater, 75080
- UT Southwestern Clinical Center at Richardson/Plano
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San Antonio, Texas, Forenede Stater, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Farmington, Utah, Forenede Stater, 84025
- Farmington Health Center
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute/University of Utah
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Virginia
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Richmond, Virginia, Forenede Stater, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Forenede Stater, 23298
- VCU Massey Comprehensive Cancer Center
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West Virginia
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Charleston, West Virginia, Forenede Stater, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Eau Claire, Wisconsin, Forenede Stater, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Forenede Stater, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Forenede Stater, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Forenede Stater, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Forenede Stater, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Forenede Stater, 54476
- Marshfield Medical Center - Weston
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
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Participants must have a histologically confirmed diagnosis of metastatic papillary renal cell carcinoma (PRCC), either type 1 or type 2. (NOTE: A designation of type 1 or type 2 should be made by the local pathologist if possible but is not required). Mixed histologies which contain type 1 or type 2 along with any other RCC histology/histologies will be allowed provided that they contain a papillary component
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Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or MRI within 28 days prior to registration. All non-measurable lesions must be assessed by CT or MRI, or nuclear medicine bone scan within 42 days prior to registration. The CT from a combined positron emission tomography (PET)/CT may be used to document only non-measurable disease unless it is of diagnostic quality. If there is clinical suspicion for bone metastases at the time of enrollment (at the discretion of the investigator), bone scan must be performed at baseline (within 42 days prior to registration)
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Participants with new or progressive brain metastases (active brain metastases) must not require immediate central nervous system (CNS) specific treatment at the time of study registration or anticipated during the first cycle of therapy. Patients with leptomeningeal disease are excluded from enrolling
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Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
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Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
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Participants must not have undergone stereotactic radiotherapy within 7 days prior to initiation of study treatment, whole-brain radiotherapy within 14 days prior to initiation of study treatment, or neurosurgical resection within 28 days prior to initiation of study treatment
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Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease
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Participants, if needed, must receive a stable dose of anti-convulsant therapy
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Participants must not have cavitating pulmonary lesions
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Participants must not have uncontrolled pleural effusions, pericardial effusions, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Participants with indwelling catheters (e.g., PleurX [registered trademark]) are allowed
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Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
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Participants must not have evidence of tumor invading or encasing any major blood vessels
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Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery
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Participants must not have had prior treatment with cabozantinib for any reason
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Participants must not have had prior treatment or adjuvant therapy with PD-1/PD-L1 checkpoint inhibitors for any reason within the past 6 months
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Participants must not have received more than one prior systemic therapy for advanced or metastatic renal cell carcinoma with the exception of another VEGF inhibitor Food and Drug Administration (FDA)-approved for advanced RCC (i.e., pazopanib, bevacizumab, sorafenib or axitinib). If a participant develops metastatic disease within six months of discontinuation of adjuvant therapy, this will constitute one prior systemic therapy for advanced or metastatic RCC. If a patient develops metastatic disease and more than six months has elapsed since discontinuation of adjuvant therapy, this will not constitute prior systemic therapy for advanced or metastatic RCC
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Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inhibitors (e.g. boceprevir, cobicistat, danoprevir, elvitegravir/RIT, fluvoxamine, indinavir, itraconazole, ketoconazole, lopinavir/RIT, nefazodone, nelfinavir, posaconazole, ritonavir, telaprevir, telithromycin, tipranavir/RIT, or voriconazole,); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
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Participants must not take within 14 days prior to registration, nor plan to take while on protocol treatment, any strong CYP3A4 inducers (e.g. avasimibe, phenytoin, rifampin, rifabutin); Please refer to https://drug-interactions.medicine.iu.edu/MainTable.aspx for the updated CYP3A4 inhibitors or inducers
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Participants must complete all prior radiation therapy at least 14 days prior to registration. Participants must have recovered to =< grade 1 from all associated toxicities at the time of registration unless the toxicity is determined to be not clinically significant by the registering investigator
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Participants must not be receiving or planning to receive any other investigational agents at time of registration
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Participants must not have been diagnosed with a clinically significant autoimmune disease, exceptions such as diabetes, eczema, and vitiligo are allowed. Other non-clinically significant autoimmune diseases are allowed if approved by the registering investigator
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Participants must not be on steroid doses > 10 mg prednisone equivalent. Replacement steroid doses for adrenal insufficiency will be allowed. Also, short duration steroid therapy to prevent allergic reactions are acceptable (e.g. prior to CT imaging)
-
Participants must be >= 18 years of age
-
Participants must have a complete physical examination and medical history within 28 days prior to registration
-
Participants must have a Zubrod performance status of 0-2
-
White blood count (WBC) >= 2 x 10^3/uL (within 28 days prior to registration)
-
Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (within 28 days prior to registration)
-
Platelet count >= 100 x 10^3/uL (within 28 days prior to registration)
-
Lymphocyte count >= 0.5 x 10^3/uL (within 28 days prior to registration)
-
Hemoglobin (>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion
-
Total serum bilirubin =< 1.5 x the institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration). Participants with history of Gilbert's disease must have total bilirubin =< 5 x institutional ULN
-
Aspartate aminotransferase (AST) must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGOT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Alanine aminotransferase (ALT), must be =< 3 x the institutional ULN unless the liver is involved with the tumor, in which case serum transaminase (SGPT) must be =< 5 x the institutional ULN (within 28 days prior to registration)
-
Participants must have serum creatinine =< 2 x the institutional ULN OR creatinine clearance (either measured or calculated) > 30 mL/min and obtained within 28 days prior to registration
-
Participants must not have any clinical evidence of congestive heart failure (CHF) (specifically, New York Heart Association [NYHA] class III [moderate] or class IV [severe]) at the time of registration
-
Participants must not have known history of congenital long QT syndrome and must not have experienced unstable angina pectoris, clinically significant cardiac arrhythmias, or stroke (transient ischemic attack [TIA] or other ischemic event) within 90 days prior to registration
-
Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days of registration, unless clinically stable with ongoing medical management
-
Participants must have urine protein < 3+ within 28 days prior to registration. If urine protein is 3+ or greater, then urine protein by 24-hour collection must show less than 3 grams of protein
-
Participants must have documented blood pressure of systolic blood pressure (SBP) < 150 mm Hg or diastolic blood pressure (DBP) < 100 mm Hg within 14 days prior to registration
-
Participants with known human immunodeficiency virus (HIV) must be on effective anti-retroviral therapy at registration and have undetectable viral load within 6 months of registration
-
Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy within 6 months prior to registration, if indicated
-
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load within 6 months prior to registration
-
Participants must be able to take oral medications (i.e., swallow pills whole). Participants must not have gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures that could in the opinion of the treating investigator affect absorption, or active peptic ulcer disease. Participants with intractable nausea or vomiting are not eligible
-
Participants must not have had any clinically-significant GI bleeding within 3 months prior to registration and participants must not have a GI disorder which (at the discretion of the investigator) bears a high risk of perforation or fistula (e.g. Crohn's disease)
-
Participants must not have had hemoptysis of >= (2.5 mL) of red blood, and do not demonstrate any other signs indicative of pulmonary hemorrhage within 3 months prior registration
-
Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
-
Participants must not be pregnant or nursing, due to VEGF therapy being toxic to embryogenesis. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
-
Participants must not be on warfarin, at therapeutic doses. Low dose aspirin for cardio-protection (per local applicable guidelines) and low molecular weight heparin (LMWH) are allowed
-
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System
-
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- NOTE: For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
-
As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I (cabozantinib S-malate)
Patients receive cabozantinib S-malate PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
Andre navne:
Given PO
Andre navne:
Undergo collection of blood and urine samples
Andre navne:
Undergo CT scans
Andre navne:
Undergo bone scans
Andre navne:
|
|
Eksperimentel: Arm II (cabozantinib S-malate, atezolizumab)
Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan or MRI and blood and urine sample collection throughout the trial. Patients may also undergo bone scan throughout the trial. |
Undergo MRI
Andre navne:
Given PO
Andre navne:
Given IV
Andre navne:
Undergo collection of blood and urine samples
Andre navne:
Undergo CT scans
Andre navne:
Undergo bone scans
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression free survival
Tidsramme: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
A proportional hazards model will be used to evaluate the experimental arm compared to the control arm, adjusted for the stratification factors as covariates in the model. A one-sided p-value =< 0.05 will indicate statistical significance. Participants last known to be alive and progression free are censored at date of last contact. |
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 5 years
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall survival
Tidsramme: From date of registration to date of death due to any cause, assessed up to 5 years
|
Will be estimated by the Kaplan-Meier method, and a stratified log-rank test will be used to compare the treatment arms. Participants last known to be alive are censored at date of last contact. |
From date of registration to date of death due to any cause, assessed up to 5 years
|
|
Objective response rate
Tidsramme: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
Tidsramme: Day 1 of each cycle
|
Will be estimated to within +/- 11% (95% confidence interval). Will utilize the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 for toxicity and serious adverse event reporting. |
Day 1 of each cycle
|
Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Ledende efterforsker: Benjamin L Maughan, SWOG Cancer Research Network
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Urogenitale neoplasmer
- Neoplasmer efter sted
- Neoplasmer
- Mandlige urogenitale sygdomme
- Nyresygdomme
- Urologiske sygdomme
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Neoplasmer efter histologisk type
- Neoplasmer, kirtel og epitel
- Adenocarcinom
- Urologiske neoplasmer
- Karcinom
- Nyre-neoplasmer
- Karcinom, nyrecelle
- Undersøgelsesteknikker
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Kemiteknikker, analytisk
- Spektrumanalyse
- Håndtering af eksemplar
- Magnetisk resonansspektroskopi
- atezolizumab
- Cabozantinib
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- NCI-2022-04668
- U10CA180888 (U.S. NIH-bevilling/kontrakt)
- NCI-2022-04668 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- S2200 (Anden identifikator: CTEP)
- S2200 (Anden identifikator: SWOG)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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