Testa Cabozantinib med eller utan atezolizumab hos patienter med avancerad papillär njurcancer, PAPMET2-prövning
En randomiserad fas II-studie av Cabozantinib (NSC #761968) med eller utan Atezolizumab (NSC #783608) hos patienter med avancerad papillär njurcellscancer (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.
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arizona
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Gilbert, Arizona, Förenta staterna, 85234
- Banner MD Anderson Cancer Center
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Phoenix, Arizona, Förenta staterna, 85004
- Cancer Center at Saint Joseph's
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Arkansas
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Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
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California
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Anaheim, California, Förenta staterna, 92806
- Kaiser Permanente-Anaheim
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Baldwin Park, California, Förenta staterna, 91706
- Kaiser Permanente-Baldwin Park
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Bellflower, California, Förenta staterna, 90706
- Kaiser Permanente-Bellflower
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Duarte, California, Förenta staterna, 91010
- City of Hope Comprehensive Cancer Center
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Dublin, California, Förenta staterna, 94568
- Epic Care-Dublin
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Emeryville, California, Förenta staterna, 94608
- Epic Care Partners in Cancer Care
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Fontana, California, Förenta staterna, 92335
- Kaiser Permanente-Fontana
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Harbor City, California, Förenta staterna, 90710
- Kaiser Permanente South Bay
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Irvine, California, Förenta staterna, 92618
- Kaiser Permanente-Irvine
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Los Angeles, California, Förenta staterna, 90027
- Kaiser Permanente Los Angeles Medical Center
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Los Angeles, California, Förenta staterna, 90034
- Kaiser Permanente West Los Angeles
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Martinez, California, Förenta staterna, 94553-3156
- Contra Costa Regional Medical Center
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Ontario, California, Förenta staterna, 91761
- Kaiser Permanente-Ontario
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Panorama City, California, Förenta staterna, 91402
- Kaiser Permanente - Panorama City
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Riverside, California, Förenta staterna, 92505
- Kaiser Permanente-Riverside
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Sacramento, California, Förenta staterna, 95817
- University of California Davis Comprehensive Cancer Center
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San Diego, California, Förenta staterna, 92120
- Kaiser Permanente-San Diego Zion
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San Marcos, California, Förenta staterna, 92078
- Kaiser Permanente-San Marcos
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Walnut Creek, California, Förenta staterna, 94597
- Epic Care Cyberknife Center
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Woodland Hills, California, Förenta staterna, 91367
- Kaiser Permanente-Woodland Hills
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20007
- MedStar Georgetown University Hospital
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Förenta staterna, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Förenta staterna, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Danville, Illinois, Förenta staterna, 61832
- Carle at The Riverfront
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DeKalb, Illinois, Förenta staterna, 60115
- Northwestern Medicine Cancer Center Kishwaukee
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Effingham, Illinois, Förenta staterna, 62401
- Carle Physician Group-Effingham
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Geneva, Illinois, Förenta staterna, 60134
- Northwestern Medicine Cancer Center Delnor
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Glenview, Illinois, Förenta staterna, 60026
- Northwestern Medicine Glenview Outpatient Center
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Grayslake, Illinois, Förenta staterna, 60030
- Northwestern Medicine Grayslake Outpatient Center
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Lake Forest, Illinois, Förenta staterna, 60045
- Northwestern Medicine Lake Forest Hospital
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Mattoon, Illinois, Förenta staterna, 61938
- Carle Physician Group-Mattoon/Charleston
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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Orland Park, Illinois, Förenta staterna, 60462
- Northwestern Medicine Orland Park
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Rockford, Illinois, Förenta staterna, 61114
- UW Health Carbone Cancer Center Rockford
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Shiloh, Illinois, Förenta staterna, 62269
- Memorial Hospital East
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Warrenville, Illinois, Förenta staterna, 60555
- Northwestern Medicine Cancer Center Warrenville
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Washington, Illinois, Förenta staterna, 61571
- Illinois CancerCare - Washington
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Ankeny, Iowa, Förenta staterna, 50023
- UI Health Care Mission Cancer and Blood - Ankeny Clinic
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Clive, Iowa, Förenta staterna, 50325
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50314
- Mercy Medical Center - Des Moines
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Des Moines, Iowa, Förenta staterna, 50309
- UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des Moines, Iowa, Förenta staterna, 50314
- UI Health Care Mission Cancer and Blood - Laurel Clinic
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Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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Waukee, Iowa, Förenta staterna, 50263
- UI Health Care Mission Cancer and Blood - Waukee Clinic
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Kansas
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Topeka, Kansas, Förenta staterna, 66606
- Cotton O'Neil Cancer Center / Stormont Vail Health
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Louisiana
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Metairie, Louisiana, Förenta staterna, 70006
- East Jefferson General Hospital
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Metairie, Louisiana, Förenta staterna, 70006
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
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Metairie, Louisiana, Förenta staterna, 70002
- Mary Bird Perkins Cancer Center - Metairie
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New Orleans, Louisiana, Förenta staterna, 70112
- University Medical Center New Orleans
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New Orleans, Louisiana, Förenta staterna, 70115
- Touro Infirmary
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Brighton, Michigan, Förenta staterna, 48114
- Trinity Health Medical Center - Brighton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health IHA Medical Group Hematology Oncology - Canton
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Canton, Michigan, Förenta staterna, 48188
- Trinity Health Medical Center - Canton
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Caro, Michigan, Förenta staterna, 48723
- Caro Cancer Center
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Chelsea, Michigan, Förenta staterna, 48118
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Chelsea, Michigan, Förenta staterna, 48118
- Chelsea Hospital
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Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
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Farmington Hills, Michigan, Förenta staterna, 48334
- Weisberg Cancer Treatment Center
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Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
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Flint, Michigan, Förenta staterna, 48503
- Genesee Hematology Oncology PC
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Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
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Flint, Michigan, Förenta staterna, 48503
- Cancer Hematology Centers - Flint
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Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
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Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
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Kalamazoo, Michigan, Förenta staterna, 49009
- Beacon Kalamazoo Cancer Center
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Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
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Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
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Marlette, Michigan, Förenta staterna, 48453
- Saint Mary's Oncology/Hematology Associates of Marlette
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Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
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Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
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Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
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Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
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Saginaw, Michigan, Förenta staterna, 48604
- Oncology Hematology Associates of Saginaw Valley PC
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Saginaw, Michigan, Förenta staterna, 48601
- MyMichigan Medical Center Saginaw
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Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Tawas City, Michigan, Förenta staterna, 48764
- MyMichigan Medical Center Tawas
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Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
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West Branch, Michigan, Förenta staterna, 48661
- Saint Mary's Oncology/Hematology Associates of West Branch
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Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
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Ypsilanti, Michigan, Förenta staterna, 48197
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
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Ypsilanti, Michigan, Förenta staterna, 48106
- Huron Gastroenterology PC
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Minnesota
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Coon Rapids, Minnesota, Förenta staterna, 55433
- Mercy Hospital
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Edina, Minnesota, Förenta staterna, 55435
- Fairview Southdale Hospital
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Maplewood, Minnesota, Förenta staterna, 55109
- Saint John's Hospital - Healtheast
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Minneapolis, Minnesota, Förenta staterna, 55407
- Abbott-Northwestern Hospital
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- Park Nicollet Clinic - Saint Louis Park
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Saint Paul, Minnesota, Förenta staterna, 55101
- Regions Hospital
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Saint Paul, Minnesota, Förenta staterna, 55102
- United Hospital
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Mississippi
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Jackson, Mississippi, Förenta staterna, 39216
- University of Mississippi Medical Center
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Missouri
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Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
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City of Saint Peters, Missouri, Förenta staterna, 63376
- Siteman Cancer Center at Saint Peters Hospital
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Creve Coeur, Missouri, Förenta staterna, 63141
- Siteman Cancer Center at West County Hospital
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Farmington, Missouri, Förenta staterna, 63640
- Parkland Health Center - Farmington
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Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
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St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
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St Louis, Missouri, Förenta staterna, 63129
- Siteman Cancer Center-South County
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St Louis, Missouri, Förenta staterna, 63136
- Siteman Cancer Center at Christian Hospital
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St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
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St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
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St Louis, Missouri, Förenta staterna, 63128
- Mercy Hospital South
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Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
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Montana
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Anaconda, Montana, Förenta staterna, 59711
- Community Hospital of Anaconda
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Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
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Billings, Montana, Förenta staterna, 59102
- Saint Vincent Frontier Cancer Center
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Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
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Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
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Kalispell, Montana, Förenta staterna, 59901
- Logan Health Medical Center
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Missoula, Montana, Förenta staterna, 59804
- Community Medical Center
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Nevada
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Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
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Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
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New Jersey
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Hackensack, New Jersey, Förenta staterna, 07601
- Hackensack University Medical Center
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North Carolina
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Cary, North Carolina, Förenta staterna, 27518
- Duke Cancer Center Cary
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Clinton, North Carolina, Förenta staterna, 28328
- Southeastern Medical Oncology Center-Clinton
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Medical Center
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Goldsboro, North Carolina, Förenta staterna, 27534
- Southeastern Medical Oncology Center-Goldsboro
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Jacksonville, North Carolina, Förenta staterna, 28546
- Southeastern Medical Oncology Center-Jacksonville
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Pinehurst, North Carolina, Förenta staterna, 28374
- FirstHealth of the Carolinas-Moore Regional Hospital
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Raleigh, North Carolina, Förenta staterna, 27609
- Duke Cancer Center Raleigh
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Ohio
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Avon, Ohio, Förenta staterna, 44011
- UH Seidman Cancer Center at UH Avon Health Center
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Beachwood, Ohio, Förenta staterna, 44122
- UHHS-Chagrin Highlands Medical Center
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Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
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Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
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Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
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Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
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Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
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Dayton, Ohio, Förenta staterna, 45409
- Premier Blood and Cancer Center
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Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
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Greenville, Ohio, Förenta staterna, 45331
- Miami Valley Cancer Care and Infusion
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Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
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Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
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Tulsa, Oklahoma, Förenta staterna, 74146
- Oklahoma Cancer Specialists and Research Institute-Tulsa
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Oregon
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Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
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Ontario, Oregon, Förenta staterna, 97914
- Saint Alphonsus Cancer Care Center-Ontario
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Oregon City, Oregon, Förenta staterna, 97045
- Providence Willamette Falls Medical Center
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Portland, Oregon, Förenta staterna, 97239
- Oregon Health and Science University
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Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
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Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
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Texas
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Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
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Dallas, Texas, Förenta staterna, 75237
- UT Southwestern Simmons Cancer Center - RedBird
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Fort Worth, Texas, Förenta staterna, 76104
- UT Southwestern/Simmons Cancer Center-Fort Worth
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Richardson, Texas, Förenta staterna, 75080
- UT Southwestern Clinical Center at Richardson/Plano
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San Antonio, Texas, Förenta staterna, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Farmington, Utah, Förenta staterna, 84025
- Farmington Health Center
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Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute/University of Utah
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Virginia
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Richmond, Virginia, Förenta staterna, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
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West Virginia
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Charleston, West Virginia, Förenta staterna, 25304
- Vandalia Health/CAMC Institute for Academic Medicine
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Wisconsin
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Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Medical Center-EC Cancer Center
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Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
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Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
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Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
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Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
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Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
-
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
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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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm 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
Andra namn:
Given PO
Andra namn:
Undergo collection of blood and urine samples
Andra namn:
Undergo CT scans
Andra namn:
Undergo bone scans
Andra namn:
|
|
Experimentell: 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
Andra namn:
Given PO
Andra namn:
Given IV
Andra namn:
Undergo collection of blood and urine samples
Andra namn:
Undergo CT scans
Andra namn:
Undergo bone scans
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression free survival
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall survival
Tidsram: 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
Tidsram: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval). |
Up to 5 years
|
|
Incidence of adverse events
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Benjamin L Maughan, SWOG Cancer Research Network
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Manliga urogenitala sjukdomar
- Njursjukdomar
- Urologiska sjukdomar
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Neoplasmer efter histologisk typ
- Neoplasmer, körtel och epitel
- Adenocarcinom
- Urologiska neoplasmer
- Carcinom
- Neoplasmer i njurarna
- Karcinom, njurcell
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Kemitekniker, analytiska
- Spektrumanalys
- Provhantering
- Magnetresonansspektroskopi
- atezolizumab
- cabozantinib
Andra studie-ID-nummer
- NCI-2022-04668
- U10CA180888 (U.S.S. NIH-anslag/kontrakt)
- NCI-2022-04668 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- S2200 (Annan identifierare: CTEP)
- S2200 (Annan identifierare: SWOG)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
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