Testování kabozantinibu s atezolizumabem nebo bez něj u pacientů s pokročilým papilárním karcinomem ledvin, studie PAPMET2
Randomizovaná studie fáze II s Cabozantinibem (NSC #761968) s atezolizumabem nebo bez něj (NSC #783608) u pacientů s pokročilým papilárním renálním karcinomem (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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Arizona
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Gilbert, Arizona, Spojené státy, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Spojené státy, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Little Rock, Arkansas, Spojené státy, 72205
- University of Arkansas for Medical Sciences
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California
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Anaheim, California, Spojené státy, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Spojené státy, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Spojené státy, 90706
- Kaiser Permanente-Bellflower
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Duarte, California, Spojené státy, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Spojené státy, 94568
- Epic Care-Dublin
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Emeryville, California, Spojené státy, 94608
- Epic Care Partners in Cancer Care
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Fontana, California, Spojené státy, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Spojené státy, 90710
- Kaiser Permanente South Bay
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Irvine, California, Spojené státy, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Spojené státy, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Spojené státy, 90034
- Kaiser Permanente West Los Angeles
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Martinez, California, Spojené státy, 94553-3156
- Contra Costa Regional Medical Center
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Ontario, California, Spojené státy, 91761
- Kaiser Permanente-Ontario
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Panorama City, California, Spojené státy, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Spojené státy, 92505
- Kaiser Permanente-Riverside
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Sacramento, California, Spojené státy, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Spojené státy, 92120
- Kaiser Permanente-San Diego Zion
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San Marcos, California, Spojené státy, 92078
- Kaiser Permanente-San Marcos
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Walnut Creek, California, Spojené státy, 94597
- Epic Care Cyberknife Center
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Woodland Hills, California, Spojené státy, 91367
- Kaiser Permanente-Woodland Hills
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District of Columbia
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Washington D.C., District of Columbia, Spojené státy, 20007
- MedStar Georgetown University Hospital
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Idaho
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Boise, Idaho, Spojené státy, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Spojené státy, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Spojené státy, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Spojené státy, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Spojené státy, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Spojené státy, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Spojené státy, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Spojené státy, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Spojené státy, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Spojené státy, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Spojené státy, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Spojené státy, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Spojené státy, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Spojené státy, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Spojené státy, 60611
- Northwestern University
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Danville, Illinois, Spojené státy, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Spojené státy, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Spojené státy, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Spojené státy, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Spojené státy, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Spojené státy, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Spojené státy, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Spojené státy, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Spojené státy, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Spojené státy, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Spojené státy, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Spojené státy, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Spojené státy, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Spojené státy, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Spojené státy, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Spojené státy, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Spojené státy, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Spojené státy, 62269
- Cancer Care Center of O'Fallon
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Orland Park, Illinois, Spojené státy, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Spojené státy, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Spojené státy, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Spojené státy, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Spojené státy, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Spojené státy, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Spojené státy, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Spojené státy, 62269
- Memorial Hospital East
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Springfield, Illinois, Spojené státy, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Spojené státy, 62702
- Springfield Clinic
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Springfield, Illinois, Spojené státy, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Spojené státy, 61801
- Carle Cancer Center
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Warrenville, Illinois, Spojené státy, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Spojené státy, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Spojené státy, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Spojené státy, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Spojené státy, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Spojené státy, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Spojené státy, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Spojené státy, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Spojené státy, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Spojené státy, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Spojené státy, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Spojené státy, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Spojené státy, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Spojené státy, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Topeka, Kansas, Spojené státy, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Louisiana
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Metairie, Louisiana, Spojené státy, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Spojené státy, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Metairie, Louisiana, Spojené státy, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Spojené státy, 70112
- University Medical Center New Orleans
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New Orleans, Louisiana, Spojené státy, 70115
- Touro Infirmary
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Maryland
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Baltimore, Maryland, Spojené státy, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Spojené státy, 49017
- Bronson Battle Creek
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Brighton, Michigan, Spojené státy, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Spojené státy, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Spojené státy, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Spojené státy, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Spojené státy, 48723
- Caro Cancer Center
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Chelsea, Michigan, Spojené státy, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Spojené státy, 48118
- Chelsea Hospital
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Detroit, Michigan, Spojené státy, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, Spojené státy, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Spojené státy, 48503
- Hurley Medical Center
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Flint, Michigan, Spojené státy, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Spojené státy, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Spojené státy, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Spojené státy, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Spojené státy, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Spojené státy, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Spojené státy, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Spojené státy, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Spojené státy, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Marlette, Michigan, Spojené státy, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Muskegon, Michigan, Spojené státy, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Spojené státy, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Spojené státy, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Spojené státy, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw, Michigan, Spojené státy, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Spojené státy, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Spojené státy, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Tawas City, Michigan, Spojené státy, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Spojené státy, 49684
- Munson Medical Center
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West Branch, Michigan, Spojené státy, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Spojené státy, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Spojené státy, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Spojené státy, 48106
- Huron Gastroenterology PC
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Minnesota
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Coon Rapids, Minnesota, Spojené státy, 55433
- Mercy Hospital
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Edina, Minnesota, Spojené státy, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Spojené státy, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Spojené státy, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Spojené státy, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Spojené státy, 55101
- Regions Hospital
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Saint Paul, Minnesota, Spojené státy, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Spojené státy, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Spojené státy, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Spojené státy, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Spojené státy, 63141
- Siteman Cancer Center at West County Hospital
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Farmington, Missouri, Spojené státy, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Spojené státy, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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St Louis, Missouri, Spojené státy, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Spojené státy, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Spojené státy, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Spojené státy, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Spojené státy, 63128
- Mercy Hospital South
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Sullivan, Missouri, Spojené státy, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Spojené státy, 59711
- Community Hospital of Anaconda
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Billings, Montana, Spojené státy, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Spojené státy, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Spojené státy, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Spojené státy, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Spojené státy, 59901
- Logan Health Medical Center
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Missoula, Montana, Spojené státy, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, Spojené státy, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Spojené státy, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Hackensack, New Jersey, Spojené státy, 07601
- Hackensack University Medical Center
-
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North Carolina
-
Cary, North Carolina, Spojené státy, 27518
- Duke Cancer Center Cary
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Clinton, North Carolina, Spojené státy, 28328
- Southeastern Medical Oncology Center-Clinton
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Durham, North Carolina, Spojené státy, 27710
- Duke University Medical Center
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Goldsboro, North Carolina, Spojené státy, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Spojené státy, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Pinehurst, North Carolina, Spojené státy, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Raleigh, North Carolina, Spojené státy, 27609
- Duke Cancer Center Raleigh
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Ohio
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Avon, Ohio, Spojené státy, 44011
- UH Seidman Cancer Center at UH Avon Health Center
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Beachwood, Ohio, Spojené státy, 44122
- UHHS-Chagrin Highlands Medical Center
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Centerville, Ohio, Spojené státy, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Spojené státy, 44106
- Case Western Reserve University
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Dayton, Ohio, Spojené státy, 45409
- Miami Valley Hospital
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Dayton, Ohio, Spojené státy, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Spojené státy, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Spojené státy, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Spojené státy, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Spojené státy, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Spojené státy, 45429
- Kettering Medical Center
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Troy, Ohio, Spojené státy, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Spojené státy, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Newberg, Oregon, Spojené státy, 97132
- Providence Newberg Medical Center
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Ontario, Oregon, Spojené státy, 97914
- Saint Alphonsus Cancer Care Center-Ontario
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Oregon City, Oregon, Spojené státy, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Spojené státy, 97239
- Oregon Health and Science University
-
Portland, Oregon, Spojené státy, 97213
- Providence Portland Medical Center
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Portland, Oregon, Spojené státy, 97225
- Providence Saint Vincent Medical Center
-
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Texas
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Dallas, Texas, Spojené státy, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Spojené státy, 75237
- UT Southwestern Simmons Cancer Center - RedBird
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Fort Worth, Texas, Spojené státy, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
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Richardson, Texas, Spojené státy, 75080
- UT Southwestern Clinical Center at Richardson/Plano
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San Antonio, Texas, Spojené státy, 78229
- University of Texas Health Science Center at San Antonio
-
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Utah
-
Farmington, Utah, Spojené státy, 84025
- Farmington Health Center
-
Salt Lake City, Utah, Spojené státy, 84112
- Huntsman Cancer Institute/University of Utah
-
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Virginia
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Richmond, Virginia, Spojené státy, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Spojené státy, 23298
- VCU Massey Comprehensive Cancer Center
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West Virginia
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Charleston, West Virginia, Spojené státy, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Eau Claire, Wisconsin, Spojené státy, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Spojené státy, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Spojené státy, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Spojené státy, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Spojené státy, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Spojené státy, 54476
- Marshfield Medical Center - Weston
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
-
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
-
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
-
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
-
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
-
Participants must not be receiving or planning to receive any other investigational agents at time of registration
-
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
-
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Aktivní komparátor: 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
Ostatní jména:
Given PO
Ostatní jména:
Undergo collection of blood and urine samples
Ostatní jména:
Undergo CT scans
Ostatní jména:
Undergo bone scans
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Given PO
Ostatní jména:
Given IV
Ostatní jména:
Undergo collection of blood and urine samples
Ostatní jména:
Undergo CT scans
Ostatní jména:
Undergo bone scans
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression free survival
Časové okno: 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
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall survival
Časové okno: 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
Časové okno: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Benjamin L Maughan, SWOG Cancer Research Network
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Mužská urogenitální onemocnění
- Onemocnění ledvin
- Urologická onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Novotvary podle histologického typu
- Novotvary, žlázové a epiteliální
- Adenokarcinom
- Urologické novotvary
- Karcinom
- Novotvary ledvin
- Karcinom, renální buňka
- Vyšetřovací techniky
- Klinické laboratorní techniky
- Diagnostické techniky a postupy
- Diagnóza
- Techniky chemie, analytické
- Analýza spektra
- Manipulace se vzorkem
- Magnetická rezonanční spektroskopie
- Atezolizumab
- Cabozantinib
Další identifikační čísla studie
Další identifikační čísla studie
- NCI-2022-04668
- U10CA180888 (Grant/smlouva NIH USA)
- NCI-2022-04668 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
- S2200 (Jiný identifikátor: CTEP)
- S2200 (Jiný identifikátor: SWOG)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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