Prueba de cabozantinib con o sin atezolizumab en pacientes con cáncer de riñón papilar avanzado, ensayo PAPMET2
Un ensayo aleatorizado de fase II de cabozantinib (NSC n.° 761968) con o sin atezolizumab (NSC n.° 783608) en pacientes con carcinoma papilar de células renales avanzado (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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Arizona
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Gilbert, Arizona, Estados Unidos, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Estados Unidos, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- University of Arkansas for Medical Sciences
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California
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Anaheim, California, Estados Unidos, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Estados Unidos, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Estados Unidos, 90706
- Kaiser Permanente-Bellflower
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Duarte, California, Estados Unidos, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Estados Unidos, 94568
- Epic Care-Dublin
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Emeryville, California, Estados Unidos, 94608
- Epic Care Partners in Cancer Care
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Fontana, California, Estados Unidos, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Estados Unidos, 90710
- Kaiser Permanente South Bay
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Irvine, California, Estados Unidos, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Estados Unidos, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Estados Unidos, 90034
- Kaiser Permanente West Los Angeles
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Martinez, California, Estados Unidos, 94553-3156
- Contra Costa Regional Medical Center
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Ontario, California, Estados Unidos, 91761
- Kaiser Permanente-Ontario
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Panorama City, California, Estados Unidos, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Estados Unidos, 92505
- Kaiser Permanente-Riverside
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Sacramento, California, Estados Unidos, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Estados Unidos, 92120
- Kaiser Permanente-San Diego Zion
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San Marcos, California, Estados Unidos, 92078
- Kaiser Permanente-San Marcos
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Walnut Creek, California, Estados Unidos, 94597
- Epic Care Cyberknife Center
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Woodland Hills, California, Estados Unidos, 91367
- Kaiser Permanente-Woodland Hills
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- MedStar Georgetown University Hospital
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Idaho
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Boise, Idaho, Estados Unidos, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Estados Unidos, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Estados Unidos, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Estados Unidos, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Estados Unidos, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Estados Unidos, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Estados Unidos, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Estados Unidos, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Estados Unidos, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Estados Unidos, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Estados Unidos, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Estados Unidos, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Estados Unidos, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Estados Unidos, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Danville, Illinois, Estados Unidos, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Estados Unidos, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Estados Unidos, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Estados Unidos, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Estados Unidos, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Estados Unidos, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Estados Unidos, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Estados Unidos, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Estados Unidos, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Estados Unidos, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Estados Unidos, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Estados Unidos, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Estados Unidos, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Estados Unidos, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Estados Unidos, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Estados Unidos, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Estados Unidos, 62269
- Cancer Care Center of O'Fallon
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Orland Park, Illinois, Estados Unidos, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Estados Unidos, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Estados Unidos, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Estados Unidos, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Estados Unidos, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Estados Unidos, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Estados Unidos, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Estados Unidos, 62269
- Memorial Hospital East
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Springfield, Illinois, Estados Unidos, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Estados Unidos, 62702
- Springfield Clinic
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Springfield, Illinois, Estados Unidos, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Warrenville, Illinois, Estados Unidos, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Estados Unidos, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Estados Unidos, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Estados Unidos, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Estados Unidos, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Estados Unidos, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Estados Unidos, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Estados Unidos, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Estados Unidos, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Estados Unidos, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Estados Unidos, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Estados Unidos, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Metairie, Louisiana, Estados Unidos, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Estados Unidos, 70112
- University Medical Center New Orleans
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New Orleans, Louisiana, Estados Unidos, 70115
- Touro Infirmary
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Estados Unidos, 49017
- Bronson Battle Creek
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Brighton, Michigan, Estados Unidos, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Estados Unidos, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Estados Unidos, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Estados Unidos, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Estados Unidos, 48723
- Caro Cancer Center
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Chelsea, Michigan, Estados Unidos, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Estados Unidos, 48118
- Chelsea Hospital
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Detroit, Michigan, Estados Unidos, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, Estados Unidos, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Estados Unidos, 48503
- Hurley Medical Center
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Flint, Michigan, Estados Unidos, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Estados Unidos, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Estados Unidos, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Estados Unidos, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Estados Unidos, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Estados Unidos, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Estados Unidos, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Estados Unidos, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Estados Unidos, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Marlette, Michigan, Estados Unidos, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Muskegon, Michigan, Estados Unidos, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Estados Unidos, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Estados Unidos, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Estados Unidos, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw, Michigan, Estados Unidos, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Estados Unidos, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Estados Unidos, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Tawas City, Michigan, Estados Unidos, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Estados Unidos, 49684
- Munson Medical Center
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West Branch, Michigan, Estados Unidos, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Estados Unidos, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Estados Unidos, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Estados Unidos, 48106
- Huron Gastroenterology PC
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Minnesota
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Coon Rapids, Minnesota, Estados Unidos, 55433
- Mercy Hospital
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Edina, Minnesota, Estados Unidos, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Estados Unidos, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Estados Unidos, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Estados Unidos, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Estados Unidos, 55101
- Regions Hospital
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Saint Paul, Minnesota, Estados Unidos, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Estados Unidos, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Estados Unidos, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Estados Unidos, 63141
- Siteman Cancer Center at West County Hospital
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Farmington, Missouri, Estados Unidos, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Estados Unidos, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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St Louis, Missouri, Estados Unidos, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Estados Unidos, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Estados Unidos, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Estados Unidos, 63128
- Mercy Hospital South
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Sullivan, Missouri, Estados Unidos, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Estados Unidos, 59711
- Community Hospital of Anaconda
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Billings, Montana, Estados Unidos, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Estados Unidos, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Estados Unidos, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Estados Unidos, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Estados Unidos, 59901
- Logan Health Medical Center
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Missoula, Montana, Estados Unidos, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Estados Unidos, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Hackensack, New Jersey, Estados Unidos, 07601
- Hackensack University Medical Center
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North Carolina
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Cary, North Carolina, Estados Unidos, 27518
- Duke Cancer Center Cary
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Clinton, North Carolina, Estados Unidos, 28328
- Southeastern Medical Oncology Center-Clinton
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Goldsboro, North Carolina, Estados Unidos, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Estados Unidos, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Pinehurst, North Carolina, Estados Unidos, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Raleigh, North Carolina, Estados Unidos, 27609
- Duke Cancer Center Raleigh
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Ohio
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Avon, Ohio, Estados Unidos, 44011
- UH Seidman Cancer Center at UH Avon Health Center
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Beachwood, Ohio, Estados Unidos, 44122
- UHHS-Chagrin Highlands Medical Center
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Centerville, Ohio, Estados Unidos, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Estados Unidos, 44106
- Case Western Reserve University
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Dayton, Ohio, Estados Unidos, 45409
- Miami Valley Hospital
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Dayton, Ohio, Estados Unidos, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Estados Unidos, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Estados Unidos, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Estados Unidos, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Estados Unidos, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Estados Unidos, 45429
- Kettering Medical Center
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Troy, Ohio, Estados Unidos, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Estados Unidos, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Newberg, Oregon, Estados Unidos, 97132
- Providence Newberg Medical Center
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Ontario, Oregon, Estados Unidos, 97914
- Saint Alphonsus Cancer Care Center-Ontario
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Oregon City, Oregon, Estados Unidos, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Estados Unidos, 97239
- Oregon Health and Science University
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Portland, Oregon, Estados Unidos, 97213
- Providence Portland Medical Center
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Portland, Oregon, Estados Unidos, 97225
- Providence Saint Vincent Medical Center
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Texas
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Dallas, Texas, Estados Unidos, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Estados Unidos, 75237
- UT Southwestern Simmons Cancer Center - RedBird
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Fort Worth, Texas, Estados Unidos, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
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Richardson, Texas, Estados Unidos, 75080
- UT Southwestern Clinical Center at Richardson/Plano
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Farmington, Utah, Estados Unidos, 84025
- Farmington Health Center
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Salt Lake City, Utah, Estados Unidos, 84112
- Huntsman Cancer Institute/University of Utah
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Virginia
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Richmond, Virginia, Estados Unidos, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Estados Unidos, 23298
- VCU Massey Comprehensive Cancer Center
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West Virginia
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Charleston, West Virginia, Estados Unidos, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Eau Claire, Wisconsin, Estados Unidos, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Estados Unidos, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Estados Unidos, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Estados Unidos, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Estados Unidos, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Estados Unidos, 54476
- Marshfield Medical Center - Weston
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
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Participants must be >= 18 years of age
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Participants must have a complete physical examination and medical history within 28 days prior to registration
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Participants must have a Zubrod performance status of 0-2
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White blood count (WBC) >= 2 x 10^3/uL (within 28 days prior to registration)
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Absolute neutrophil count (ANC) >= 1.5 x 10^3/uL (within 28 days prior to registration)
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Platelet count >= 100 x 10^3/uL (within 28 days prior to registration)
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Lymphocyte count >= 0.5 x 10^3/uL (within 28 days prior to registration)
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Hemoglobin (>= 9 g/dL) (within 28 days prior to registration). Participants may be transfused to meet this criterion
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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
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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)
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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)
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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
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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
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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
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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
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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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
Otros nombres:
Given PO
Otros nombres:
Undergo collection of blood and urine samples
Otros nombres:
Undergo CT scans
Otros nombres:
Undergo bone scans
Otros nombres:
|
|
Experimental: 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
Otros nombres:
Given PO
Otros nombres:
Given IV
Otros nombres:
Undergo collection of blood and urine samples
Otros nombres:
Undergo CT scans
Otros nombres:
Undergo bone scans
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Progression free survival
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall survival
Periodo de tiempo: 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
Periodo de tiempo: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Benjamin L Maughan, SWOG Cancer Research Network
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Urológicas
- Carcinoma
- Neoplasias Renales
- Carcinoma De Célula Renal
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Técnicas de química, analítica
- Análisis de espectro
- Manejo de muestras
- Espectroscopía de resonancia magnética
- atezolizumab
- taza de taxis
Otros números de identificación del estudio
- NCI-2022-04668
- U10CA180888 (Subvención/contrato del NIH de EE. UU.)
- NCI-2022-04668 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- S2200 (Otro identificador: CTEP)
- S2200 (Otro identificador: SWOG)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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