- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05411081
Testing Cabozantinib With or Without Atezolizumab in Patients With Advanced Papillary Kidney Cancer, PAPMET2 Trial
A Phase II Randomized Trial of Cabozantinib (NSC #761968) With or Without Atezolizumab (NSC #783608) in Patients With Advanced Papillary Renal Cell Carcinoma (PAPMET2)
Study Overview
Status
Detailed Description
PRIMARY OBJECTIVE:
I. To compare progression-free survival in participants with metastatic papillary renal cell carcinoma (mPRCC) randomized to cabozantinib S-malate (cabozantinib) 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) and bone scans throughout the trial. Patients may also undergo collection of blood samples 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 and bone scans throughout the trial. Patients may also undergo collection of blood samples 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85004
- Recruiting
- Cancer Center at Saint Joseph's
-
Principal Investigator:
- Shahzad Siddique
-
Contact:
- Site Public Contact
- Phone Number: 720-874-1881
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- University of Arkansas for Medical Sciences
-
Principal Investigator:
- Shi-Ming Tu
-
Contact:
- Site Public Contact
- Phone Number: 501-686-8274
-
-
California
-
Anaheim, California, United States, 92806
- Recruiting
- Kaiser Permanente-Anaheim
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Baldwin Park, California, United States, 91706
- Recruiting
- Kaiser Permanente-Baldwin Park
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Bellflower, California, United States, 90706
- Recruiting
- Kaiser Permanente-Bellflower
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Duarte, California, United States, 91010
- Recruiting
- City of Hope Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-826-4673
- Email: becomingapatient@coh.org
-
Principal Investigator:
- Sumanta K. Pal
-
Dublin, California, United States, 94568
- Recruiting
- Epic Care-Dublin
-
Contact:
- Site Public Contact
- Phone Number: 925-875-1677
-
Principal Investigator:
- Lisa Bailey
-
Emeryville, California, United States, 94608
- Recruiting
- Epic Care Partners in Cancer Care
-
Principal Investigator:
- Lisa Bailey
-
Contact:
- Site Public Contact
- Phone Number: 510-629-6682
-
Fontana, California, United States, 92335
- Recruiting
- Kaiser Permanente-Fontana
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Harbor City, California, United States, 90710
- Recruiting
- Kaiser Permanente - Harbor City
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Irvine, California, United States, 92618
- Recruiting
- Kaiser Permanente-Irvine
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Los Angeles, California, United States, 90027
- Recruiting
- Kaiser Permanente Los Angeles Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Los Angeles, California, United States, 90034
- Recruiting
- Kaiser Permanente West Los Angeles
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Martinez, California, United States, 94553-3156
- Recruiting
- Contra Costa Regional Medical Center
-
Principal Investigator:
- Lisa Bailey
-
Contact:
- Site Public Contact
- Phone Number: 925-957-5400
-
Ontario, California, United States, 91761
- Recruiting
- Kaiser Permanente-Ontario
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Panorama City, California, United States, 91402
- Recruiting
- Kaiser Permanente - Panorama City
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Riverside, California, United States, 92505
- Recruiting
- Kaiser Permanente-Riverside
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Sacramento, California, United States, 95817
- Recruiting
- University of California Davis Comprehensive Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 916-734-3089
-
Principal Investigator:
- Shuchi Gulati
-
San Diego, California, United States, 92120
- Recruiting
- Kaiser Permanente-San Diego Zion
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
San Marcos, California, United States, 92078
- Recruiting
- Kaiser Permanente-San Marcos
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
Walnut Creek, California, United States, 94597
- Recruiting
- Epic Care Cyberknife Center
-
Principal Investigator:
- Lisa Bailey
-
Contact:
- Site Public Contact
- Phone Number: 510-465-8016
- Email: somega@bati.org
-
Woodland Hills, California, United States, 91367
- Recruiting
- Kaiser Permanente-Woodland Hills
-
Contact:
- Site Public Contact
- Phone Number: 800-398-3996
- Email: clinical.trials@kp.org
-
Principal Investigator:
- Helen H. Moon
-
-
Idaho
-
Boise, Idaho, United States, 83712
- Recruiting
- Saint Luke's Cancer Institute - Boise
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Charles W. Drescher
-
Fruitland, Idaho, United States, 83619
- Recruiting
- Saint Luke's Cancer Institute - Fruitland
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Charles W. Drescher
-
Meridian, Idaho, United States, 83642
- Recruiting
- Saint Luke's Cancer Institute - Meridian
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Charles W. Drescher
-
Nampa, Idaho, United States, 83686
- Recruiting
- Saint Luke's Cancer Institute - Nampa
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Charles W. Drescher
-
Twin Falls, Idaho, United States, 83301
- Recruiting
- Saint Luke's Cancer Institute - Twin Falls
-
Contact:
- Site Public Contact
- Phone Number: 208-381-2774
- Email: eslinget@slhs.org
-
Principal Investigator:
- Charles W. Drescher
-
-
Illinois
-
Bloomington, Illinois, United States, 61704
- Recruiting
- Illinois CancerCare-Bloomington
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Canton, Illinois, United States, 61520
- Recruiting
- Illinois CancerCare-Canton
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Carthage, Illinois, United States, 62321
- Recruiting
- Illinois CancerCare-Carthage
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Principal Investigator:
- Niraj K. Shenoy
-
Danville, Illinois, United States, 61832
- Recruiting
- Carle at The Riverfront
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Vamsi K. Vasireddy
-
DeKalb, Illinois, United States, 60115
- Recruiting
- Northwestern Medicine Cancer Center Kishwaukee
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Niraj K. Shenoy
-
Decatur, Illinois, United States, 62526
- Recruiting
- Cancer Care Specialists of Illinois - Decatur
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Decatur, Illinois, United States, 62526
- Recruiting
- Decatur Memorial Hospital
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Dixon, Illinois, United States, 61021
- Recruiting
- Illinois CancerCare-Dixon
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 815-285-7800
-
Effingham, Illinois, United States, 62401
- Recruiting
- Carle Physician Group-Effingham
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Vamsi K. Vasireddy
-
Effingham, Illinois, United States, 62401
- Recruiting
- Crossroads Cancer Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Eureka, Illinois, United States, 61530
- Recruiting
- Illinois CancerCare-Eureka
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Galesburg, Illinois, United States, 61401
- Recruiting
- Illinois CancerCare-Galesburg
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Geneva, Illinois, United States, 60134
- Recruiting
- Northwestern Medicine Cancer Center Delnor
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Niraj K. Shenoy
-
Glenview, Illinois, United States, 60026
- Recruiting
- Northwestern Medicine Glenview Outpatient Center
-
Principal Investigator:
- Niraj K. Shenoy
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1102
-
Grayslake, Illinois, United States, 60030
- Recruiting
- Northwestern Medicine Grayslake Outpatient Center
-
Principal Investigator:
- Niraj K. Shenoy
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1102
-
Kewanee, Illinois, United States, 61443
- Recruiting
- Illinois CancerCare-Kewanee Clinic
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Lake Forest, Illinois, United States, 60045
- Recruiting
- Northwestern Medicine Lake Forest Hospital
-
Contact:
- Site Public Contact
- Email: cancertrials@northwestern.edu
-
Principal Investigator:
- Niraj K. Shenoy
-
Macomb, Illinois, United States, 61455
- Recruiting
- Illinois CancerCare-Macomb
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Mattoon, Illinois, United States, 61938
- Recruiting
- Carle Physician Group-Mattoon/Charleston
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Vamsi K. Vasireddy
-
Maywood, Illinois, United States, 60153
- Recruiting
- Loyola University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 708-226-4357
-
Principal Investigator:
- Joseph I. Clark
-
O'Fallon, Illinois, United States, 62269
- Recruiting
- Cancer Care Center of O'Fallon
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4762
- Email: morganthaler.jodi@mhsil.com
-
Orland Park, Illinois, United States, 60462
- Recruiting
- Northwestern Medicine Orland Park
-
Principal Investigator:
- Niraj K. Shenoy
-
Contact:
- Site Public Contact
- Email: nctnprogram_rhlccc@northwestern.edu
-
Ottawa, Illinois, United States, 61350
- Recruiting
- Illinois CancerCare-Ottawa Clinic
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Pekin, Illinois, United States, 61554
- Recruiting
- Illinois CancerCare-Pekin
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Peoria, Illinois, United States, 61615
- Recruiting
- Illinois CancerCare-Peoria
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Peru, Illinois, United States, 61354
- Recruiting
- Illinois CancerCare-Peru
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Princeton, Illinois, United States, 61356
- Recruiting
- Illinois CancerCare-Princeton
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Springfield, Illinois, United States, 62702
- Recruiting
- Southern Illinois University School of Medicine
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-545-7929
-
Springfield, Illinois, United States, 62702
- Recruiting
- Springfield Clinic
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 800-444-7541
-
Springfield, Illinois, United States, 62781
- Recruiting
- Memorial Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-528-7541
- Email: pallante.beth@mhsil.com
-
Urbana, Illinois, United States, 61801
- Recruiting
- Carle Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Vamsi K. Vasireddy
-
Warrenville, Illinois, United States, 60555
- Recruiting
- Northwestern Medicine Cancer Center Warrenville
-
Contact:
- Site Public Contact
- Phone Number: 630-352-5360
- Email: Donald.Smith3@nm.org
-
Principal Investigator:
- Niraj K. Shenoy
-
Washington, Illinois, United States, 61571
- Recruiting
- Illinois CancerCare - Washington
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Recruiting
- Mary Greeley Medical Center
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-956-4132
-
Ames, Iowa, United States, 50010
- Recruiting
- McFarland Clinic - Ames
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-239-4734
- Email: ksoder@mcfarlandclinic.com
-
Boone, Iowa, United States, 50036
- Recruiting
- McFarland Clinic - Boone
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-956-4132
-
Des Moines, Iowa, United States, 50314
- Recruiting
- Mercy Medical Center - Des Moines
-
Principal Investigator:
- Richard L. Deming
-
Contact:
- Site Public Contact
- Phone Number: 515-358-6613
- Email: cancerresearch@mercydesmoines.org
-
Fort Dodge, Iowa, United States, 50501
- Recruiting
- McFarland Clinic - Trinity Cancer Center
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-956-4132
-
Jefferson, Iowa, United States, 50129
- Recruiting
- McFarland Clinic - Jefferson
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-956-4132
-
Marshalltown, Iowa, United States, 50158
- Recruiting
- McFarland Clinic - Marshalltown
-
Principal Investigator:
- Joseph J. Merchant
-
Contact:
- Site Public Contact
- Phone Number: 515-956-4132
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Recruiting
- Cotton O'Neil Cancer Center / Stormont Vail Health
-
Contact:
- Site Public Contact
- Phone Number: 785-270-4939
-
Principal Investigator:
- Brandon R. Weckbaugh
-
-
Louisiana
-
Metairie, Louisiana, United States, 70006
- Recruiting
- East Jefferson General Hospital
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Carrie Marquette
-
Metairie, Louisiana, United States, 70006
- Recruiting
- LSU Healthcare Network / Metairie Multi-Specialty Clinic
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Carrie Marquette
-
New Orleans, Louisiana, United States, 70112
- Recruiting
- University Medical Center New Orleans
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Carrie Marquette
-
New Orleans, Louisiana, United States, 70115
- Recruiting
- Touro Infirmary
-
Contact:
- Site Public Contact
- Phone Number: 504-210-3539
- Email: emede1@lsuhsc.edu
-
Principal Investigator:
- Carrie Marquette
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 410-955-8804
- Email: jhcccro@jhmi.edu
-
Principal Investigator:
- Yasser Ged
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Recruiting
- Saint Joseph Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Battle Creek, Michigan, United States, 49017
- Recruiting
- Bronson Battle Creek
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Brighton, Michigan, United States, 48114
- Recruiting
- Saint Joseph Mercy Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Brighton, Michigan, United States, 48114
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Brighton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Canton, Michigan, United States, 48188
- Recruiting
- Saint Joseph Mercy Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Canton, Michigan, United States, 48188
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Canton
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Caro, Michigan, United States, 48723
- Recruiting
- Caro Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Saint Joseph Mercy Chelsea
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Detroit, Michigan, United States, 48201
- Recruiting
- Wayne State University/Karmanos Cancer Institute
-
Principal Investigator:
- Elisabeth I. Heath
-
Contact:
- Site Public Contact
- Phone Number: 313-576-9790
- Email: ctoadmin@karmanos.org
-
Farmington Hills, Michigan, United States, 48334
- Recruiting
- Weisberg Cancer Treatment Center
-
Principal Investigator:
- Elisabeth I. Heath
-
Contact:
- Site Public Contact
- Phone Number: 313-576-9790
- Email: ctoadmin@karmanos.org
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesee Cancer and Blood Disease Treatment Center
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesee Hematology Oncology PC
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesys Hurley Cancer Institute
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Hurley Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Grand Rapids, Michigan, United States, 49503
- Recruiting
- Spectrum Health at Butterworth Campus
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- Bronson Methodist Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49007
- Recruiting
- West Michigan Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Kalamazoo, Michigan, United States, 49009
- Recruiting
- Ascension Borgess Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Lansing, Michigan, United States, 48912
- Recruiting
- University of Michigan Health - Sparrow Lansing
-
Principal Investigator:
- Tareq Al Baghdadi
-
Contact:
- Site Public Contact
- Phone Number: 517-364-3712
- Email: harsha.trivedi@umhsparrow.org
-
Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Marlette, Michigan, United States, 48453
- Recruiting
- Saint Mary's Oncology/Hematology Associates of Marlette
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Muskegon, Michigan, United States, 49444
- Recruiting
- Trinity Health Muskegon Hospital
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Norton Shores, Michigan, United States, 49444
- Recruiting
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Principal Investigator:
- Kathleen J. Yost
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: connie.szczepanek@crcwm.org
-
Saginaw, Michigan, United States, 48601
- Recruiting
- Ascension Saint Mary's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Saginaw, Michigan, United States, 48604
- Recruiting
- Oncology Hematology Associates of Saginaw Valley PC
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Saint Joseph, Michigan, United States, 49085
- Recruiting
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Tawas City, Michigan, United States, 48764
- Recruiting
- Ascension Saint Joseph Hospital
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Traverse City, Michigan, United States, 49684
- Recruiting
- Munson Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
West Branch, Michigan, United States, 48661
- Recruiting
- Saint Mary's Oncology/Hematology Associates of West Branch
-
Contact:
- Site Public Contact
- Phone Number: 989-907-8411
- Email: lori.srebinski@ascension.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Wyoming, Michigan, United States, 49519
- Recruiting
- University of Michigan Health - West
-
Contact:
- Site Public Contact
- Phone Number: 616-391-1230
- Email: crcwm-regulatory@crcwm.org
-
Principal Investigator:
- Kathleen J. Yost
-
Ypsilanti, Michigan, United States, 48106
- Recruiting
- Huron Gastroenterology PC
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Ypsilanti, Michigan, United States, 48197
- Recruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
-
Contact:
- Site Public Contact
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
-
Minnesota
-
Coon Rapids, Minnesota, United States, 55433
- Recruiting
- Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Edina, Minnesota, United States, 55435
- Recruiting
- Fairview Southdale Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Maplewood, Minnesota, United States, 55109
- Recruiting
- Saint John's Hospital - Healtheast
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Minneapolis, Minnesota, United States, 55407
- Recruiting
- Abbott-Northwestern Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Saint Louis Park, Minnesota, United States, 55416
- Recruiting
- Park Nicollet Clinic - Saint Louis Park
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
Saint Paul, Minnesota, United States, 55102
- Recruiting
- United Hospital
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- David M. King
-
-
Mississippi
-
Jackson, Mississippi, United States, 39216
- Recruiting
- University of Mississippi Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 601-815-6700
-
Principal Investigator:
- John C. Henegan
-
-
Missouri
-
Cape Girardeau, Missouri, United States, 63703
- Recruiting
- Saint Francis Medical Center
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 573-334-2230
- Email: sfmc@sfmc.net
-
-
New Jersey
-
Hackensack, New Jersey, United States, 07601
- Recruiting
- Hackensack University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 201-996-2879
-
Principal Investigator:
- Robert S. Alter
-
-
North Carolina
-
Cary, North Carolina, United States, 27518
- Recruiting
- Duke Cancer Institute Cary
-
Contact:
- Site Public Contact
- Phone Number: 919-781-7070
-
Principal Investigator:
- Michael R. Harrison
-
Clinton, North Carolina, United States, 28328
- Recruiting
- Southeastern Medical Oncology Center-Clinton
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 888-275-3853
-
Principal Investigator:
- Michael R. Harrison
-
Goldsboro, North Carolina, United States, 27534
- Recruiting
- Southeastern Medical Oncology Center-Goldsboro
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Jacksonville, North Carolina, United States, 28546
- Recruiting
- Southeastern Medical Oncology Center-Jacksonville
-
Principal Investigator:
- Samer S. Kasbari
-
Contact:
- Site Public Contact
- Phone Number: 910-587-9084
- Email: jfields@cancersmoc.com
-
Pinehurst, North Carolina, United States, 28374
- Recruiting
- FirstHealth of the Carolinas-Moore Regional Hospital
-
Contact:
- Site Public Contact
- Phone Number: 910-715-3500
- Email: jcwilliams@firsthealth.org
-
Principal Investigator:
- Charles S. Kuzma
-
Raleigh, North Carolina, United States, 27609
- Recruiting
- Duke Raleigh Hospital
-
Contact:
- Site Public Contact
- Phone Number: 919-862-5400
-
Principal Investigator:
- Michael R. Harrison
-
-
Ohio
-
Avon, Ohio, United States, 44011
- Active, not recruiting
- UH Seidman Cancer Center at UH Avon Health Center
-
Beachwood, Ohio, United States, 44122
- Active, not recruiting
- UHHS-Chagrin Highlands Medical Center
-
Centerville, Ohio, United States, 45459
- Recruiting
- Miami Valley Hospital South
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Tarek M. Sabagh
-
Cleveland, Ohio, United States, 44106
- Active, not recruiting
- Case Western Reserve University
-
Dayton, Ohio, United States, 45409
- Recruiting
- Miami Valley Hospital
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Tarek M. Sabagh
-
Dayton, Ohio, United States, 45415
- Recruiting
- Dayton Physician LLC-Miami Valley Hospital North
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Howard M. Gross
-
Dayton, Ohio, United States, 45415
- Recruiting
- Miami Valley Hospital North
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Tarek M. Sabagh
-
Dayton, Ohio, United States, 45409
- Recruiting
- Dayton Blood and Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 937-276-8320
-
Principal Investigator:
- Tarek M. Sabagh
-
Franklin, Ohio, United States, 45005-1066
- Recruiting
- Atrium Medical Center-Middletown Regional Hospital
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Tarek M. Sabagh
-
Greenville, Ohio, United States, 45331
- Recruiting
- Miami Valley Cancer Care and Infusion
-
Principal Investigator:
- Tarek M. Sabagh
-
Contact:
- Site Public Contact
- Phone Number: 937-569-7515
-
Kettering, Ohio, United States, 45429
- Recruiting
- Kettering Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Howard M. Gross
-
Troy, Ohio, United States, 45373
- Recruiting
- Upper Valley Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 937-528-2900
- Email: clinical.trials@daytonncorp.org
-
Principal Investigator:
- Tarek M. Sabagh
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Adanma Anji Ayanambakkam Attanathi
-
Tulsa, Oklahoma, United States, 74146
- Recruiting
- Oklahoma Cancer Specialists and Research Institute-Tulsa
-
Contact:
- Site Public Contact
- Phone Number: 918-505-3200
-
Principal Investigator:
- Adanma Anji Ayanambakkam Attanathi
-
-
Oregon
-
Newberg, Oregon, United States, 97132
- Recruiting
- Providence Newberg Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Charles W. Drescher
-
Oregon City, Oregon, United States, 97045
- Recruiting
- Providence Willamette Falls Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Charles W. Drescher
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Site Public Contact
- Phone Number: 503-494-1080
- Email: trials@ohsu.edu
-
Principal Investigator:
- Christopher W. Ryan
-
Portland, Oregon, United States, 97213
- Recruiting
- Providence Portland Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Charles W. Drescher
-
Portland, Oregon, United States, 97225
- Recruiting
- Providence Saint Vincent Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-215-2614
- Email: CanRsrchStudies@providence.org
-
Principal Investigator:
- Charles W. Drescher
-
-
Texas
-
Dallas, Texas, United States, 75390
- Recruiting
- UT Southwestern/Simmons Cancer Center-Dallas
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Dallas, Texas, United States, 75237
- Recruiting
- UT Southwestern Simmons Cancer Center - RedBird
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Fort Worth, Texas, United States, 76104
- Recruiting
- UT Southwestern/Simmons Cancer Center-Fort Worth
-
Contact:
- Site Public Contact
- Phone Number: 214-648-7097
- Email: canceranswerline@UTSouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
Richardson, Texas, United States, 75080
- Recruiting
- UT Southwestern Clinical Center at Richardson/Plano
-
Contact:
- Site Public Contact
- Phone Number: 972-669-7044
- Email: Suzanne.cole@utsouthwestern.edu
-
Principal Investigator:
- Suzanne M. Cole
-
-
Utah
-
Farmington, Utah, United States, 84025
- Recruiting
- Farmington Health Center
-
Principal Investigator:
- Benjamin L. Maughan
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
Salt Lake City, Utah, United States, 84112
- Recruiting
- Huntsman Cancer Institute/University of Utah
-
Principal Investigator:
- Benjamin L. Maughan
-
Contact:
- Site Public Contact
- Phone Number: 888-424-2100
- Email: cancerinfo@hci.utah.edu
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Asit K. Paul
-
Richmond, Virginia, United States, 23235
- Recruiting
- VCU Massey Cancer Center at Stony Point
-
Contact:
- Site Public Contact
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Asit K. Paul
-
-
Wisconsin
-
Eau Claire, Wisconsin, United States, 54701
- Recruiting
- Marshfield Medical Center-EC Cancer Center
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Minocqua, Wisconsin, United States, 54548
- Recruiting
- Marshfield Clinic-Minocqua Center
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Stevens Point, Wisconsin, United States, 54482
- Recruiting
- Marshfield Medical Center-River Region at Stevens Point
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
Weston, Wisconsin, United States, 54476
- Recruiting
- Marshfield Medical Center - Weston
-
Contact:
- Site Public Contact
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Seth O. Fagbemi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- Participants must have measurable disease per RECIST 1.1 criteria. All measurable lesions must be assessed by CT or magnetic resonance imaging (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)
- 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
- Participants with measurable disease, per RECIST version (v)1.1, must be present outside the CNS
- Participants must have no history of intracranial hemorrhage or spinal cord hemorrhage
- Participants, if needed, must receive a stable dose of anti-convulsant therapy
- 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 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 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 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 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 for OPEN access instructions) 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
Exclusion Criteria:
- 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
- Participants must not have ongoing requirements for corticosteroids as therapy for CNS disease
- Participants must not have cavitating pulmonary lesions
- 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) are allowed
- Participants must not have tumor invading the gastrointestinal (GI) tract or evidence of endotracheal or endobronchial tumor within 28 days prior to registration
- Participants must not have evidence of tumor invading or encasing any major blood vessels
- Participants must not have had major surgery within 28 days prior to registration, and participants must have recovered from any adverse effects of surgery
- Participants must not have had prior treatment with cabozantinib for any reason
- 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 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 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 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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 and bone scans throughout the trial.
Patients may also undergo collection of blood samples throughout the trial.
|
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Undergo CT scans
Other Names:
Undergo bone scans
Other Names:
|
Experimental: Arm II (cabozantinib S-malate, atezolizumab)
Patients receive cabozantinib S-malate PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on day 1 of each cycle.
Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients also undergo CT and bone scans throughout the trial.
Patients may also undergo collection of blood samples throughout the trial.
|
Undergo collection of blood samples
Other Names:
Given PO
Other Names:
Given IV
Other Names:
Undergo CT scans
Other Names:
Undergo bone scans
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 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
Time Frame: Up to 5 years
|
Will be estimated to within +/- 11% (95% confidence interval).
|
Up to 5 years
|
Incidence of adverse events
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Benjamin L Maughan, SWOG Cancer Research Network
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Immune Checkpoint Inhibitors
- Antibodies, Monoclonal
- Atezolizumab
Other Study ID Numbers
- NCI-2022-04668 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180888 (U.S. NIH Grant/Contract)
- S2200 (Other Identifier: CTEP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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