Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors
NCT03866382
This study is recruiting at 217 US sites in 31 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Bladder Adenocarcinoma
- Bladder Clear Cell Adenocarcinoma
- Bladder Mixed Adenocarcinoma
- Bladder Neuroendocrine Carcinoma
- Bladder Small Cell Neuroendocrine Carcinoma
- Bladder Squamous Cell Carcinoma
- Chromophobe Renal Cell Carcinoma
- Collecting Duct Carcinoma
- Invasive Bladder Giant Cell Urothelial Carcinoma
- Invasive Bladder Lymphoepithelioma-Like Carcinoma
- Invasive Bladder Nested Urothelial Carcinoma
- Invasive Bladder Plasmacytoid Urothelial Carcinoma
- Invasive Bladder Sarcomatoid Urothelial Carcinoma
- Invasive Bladder Urothelial Carcinoma
- Kidney Medullary Carcinoma
- Large Cell Neuroendocrine Carcinoma
- Malignant Testicular Leydig Cell Tumor
- Malignant Testicular Sertoli Cell Tumor
- Metastatic Bladder Carcinoma
- Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma
- Metastatic Bladder Giant Cell Urothelial Carcinoma
- Metastatic Bladder Large Cell Neuroendocrine Carcinoma
- Metastatic Bladder Lipid-Rich Urothelial Carcinoma
- Metastatic Bladder Micropapillary Urothelial Carcinoma
- Metastatic Bladder Plasmacytoid Urothelial Carcinoma
- Metastatic Bladder Sarcomatoid Urothelial Carcinoma
- Metastatic Bladder Small Cell Neuroendocrine Carcinoma
- Metastatic Bladder Squamous Cell Carcinoma
- Metastatic Chromophobe Renal Cell Carcinoma
- Metastatic Kidney Medullary Carcinoma
- Metastatic Malignant Genitourinary System Neoplasm
- Metastatic Papillary Renal Cell Carcinoma
- Metastatic Penile Carcinoma
- Metastatic Prostate Small Cell Neuroendocrine Carcinoma
- Metastatic Sarcomatoid Renal Cell Carcinoma
- Metastatic Urethral Carcinoma
- Papillary Renal Cell Carcinoma
- Sarcomatoid Renal Cell Carcinoma
- Stage IV Bladder Cancer AJCC v8
- Stage IV Penile Cancer AJCC v8
- Stage IV Renal Cell Cancer AJCC v8
- Stage IV Urethral Cancer AJCC v8
- Stage IVB Prostate Cancer AJCC v8
- Urachal Adenocarcinoma
- Urethral Clear Cell Adenocarcinoma
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- National Cancer Institute (NCI)
- Last updated on ClinicalTrials.gov
- October 14, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Arizona · 2
- Mayo Clinic Hospital in Arizona · Phoenix, AZ
- Mayo Clinic in Arizona · Scottsdale, AZ
California · 4
- Keck Medicine of USC Koreatown · Los Angeles, CA
- Los Angeles General Medical Center · Los Angeles, CA
- USC / Norris Comprehensive Cancer Center · Los Angeles, CA
- USC Norris Oncology/Hematology-Newport Beach · Newport Beach, CA
District of Columbia · 1
- MedStar Georgetown University Hospital · Washington D.C., DC
Florida · 2
- Holy Cross Hospital · Fort Lauderdale, FL
- Orlando Health Cancer Institute · Orlando, FL
Georgia · 2
- Emory University Hospital Midtown · Atlanta, GA
- Emory University Hospital/Winship Cancer Institute · Atlanta, GA
Idaho · 6
- Saint Alphonsus Cancer Care Center-Boise · Boise, ID
- Saint Alphonsus Cancer Care Center-Caldwell · Caldwell, ID
- Kootenai Health - Coeur d'Alene · Coeur d'Alene, ID
- Saint Alphonsus Cancer Care Center-Nampa · Nampa, ID
- Kootenai Clinic Cancer Services - Post Falls · Post Falls, ID
- Kootenai Clinic Cancer Services - Sandpoint · Sandpoint, ID
Illinois · 15
- Rush MD Anderson Cancer Center · Chicago, IL
- University of Chicago Comprehensive Cancer Center · Chicago, IL
- Carle at The Riverfront · Danville, IL
- Cancer Care Specialists of Illinois - Decatur · Decatur, IL
- Carle Physician Group-Effingham · Effingham, IL
- Crossroads Cancer Center · Effingham, IL
- Carle Physician Group-Mattoon/Charleston · Mattoon, IL
- Loyola University Medical Center · Maywood, IL
- UC Comprehensive Cancer Center at Silver Cross · New Lenox, IL
- University of Chicago Medicine-Orland Park · Orland Park, IL
- Memorial Hospital East · Shiloh, IL
- Southern Illinois University School of Medicine · Springfield, IL
- Springfield Clinic · Springfield, IL
- Springfield Memorial Hospital · Springfield, IL
- Carle Cancer Center · Urbana, IL
Iowa · 13
- Mary Greeley Medical Center · Ames, IA
- McFarland Clinic - Ames · Ames, IA
- UI Health Care Mission Cancer and Blood - Ankeny Clinic · Ankeny, IA
- University of Iowa Healthcare Cancer Services Quad Cities · Bettendorf, IA
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic · Clive, IA
- Iowa Methodist Medical Center · Des Moines, IA
- Mercy Medical Center - Des Moines · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Des Moines Clinic · Des Moines, IA
- UI Health Care Mission Cancer and Blood - Laurel Clinic · Des Moines, IA
- McFarland Clinic - Trinity Cancer Center · Fort Dodge, IA
- University of Iowa/Holden Comprehensive Cancer Center · Iowa City, IA
- McFarland Clinic - Marshalltown · Marshalltown, IA
- UI Health Care Mission Cancer and Blood - Waukee Clinic · Waukee, IA
Kansas · 7
- HaysMed · Hays, KS
- Lawrence Memorial Hospital · Lawrence, KS
- The University of Kansas Cancer Center - Olathe · Olathe, KS
- Freeman Physician Group of Pittsburg · Pittsburg, KS
- Salina Regional Health Center · Salina, KS
- University of Kansas Health System Saint Francis Campus · Topeka, KS
- University of Kansas Hospital-Westwood Cancer Center · Westwood, KS
Kentucky · 1
- University of Kentucky/Markey Cancer Center · Lexington, KY
Louisiana · 3
- Louisiana Hematology Oncology Associates LLC · Baton Rouge, LA
- Northshore Oncology Associates-Covington · Covington, LA
- Mary Bird Perkins Cancer Center - Metairie · Metairie, LA
Maryland · 2
- National Institutes of Health Clinical Center · Bethesda, MD
- FMH James M Stockman Cancer Institute · Frederick, MD
Massachusetts · 2
- Lahey Clinic · Burlington, MA
- Lahey Clinic Peabody · Peabody, MA
Michigan · 33
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor · Ann Arbor, MI
- Trinity Health IHA Medical Group Hematology Oncology - Brighton · Brighton, MI
- Trinity Health Medical Center - Brighton · Brighton, MI
- Trinity Health IHA Medical Group Hematology Oncology - Canton · Canton, MI
- Trinity Health Medical Center - Canton · Canton, MI
- Chelsea Hospital · Chelsea, MI
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital · Chelsea, MI
- Hematology Oncology Consultants-Clarkston · Clarkston, MI
- Henry Ford Macomb Hospital-Clinton Township · Clinton Township, MI
- Henry Ford Medical Center-Fairlane · Dearborn, MI
- Henry Ford Health Saint John Hospital · Detroit, MI
- Henry Ford Hospital · Detroit, MI
- Cancer Hematology Centers - Flint · Flint, MI
- Genesys Hurley Cancer Institute · Flint, MI
- Hurley Medical Center · Flint, MI
- Henry Ford Saint John Hospital - Academic · Grosse Pointe Woods, MI
- Henry Ford Saint John Hospital - Van Elslander · Grosse Pointe Woods, MI
- Allegiance Health · Jackson, MI
- University of Michigan Health - Sparrow Lansing · Lansing, MI
- Trinity Health Saint Mary Mercy Livonia Hospital · Livonia, MI
- Henry Ford Saint John Hospital - Macomb Medical · Macomb, MI
- Henry Ford Medical Center-Columbus · Novi, MI
- Michigan Healthcare Professionals Pontiac · Pontiac, MI
- Newland Medical Associates-Pontiac · Pontiac, MI
- Trinity Health Saint Joseph Mercy Oakland Hospital · Pontiac, MI
- MyMichigan Medical Center Saginaw · Saginaw, MI
- MyMichigan Medical Center Tawas · Tawas City, MI
- Henry Ford Health Warren Hospital · Warren, MI
- Henry Ford Warren Hospital - GLCMS · Warren, MI
- Henry Ford West Bloomfield Hospital · West Bloomfield, MI
- Henry Ford Wyandotte Hospital · Wyandotte, MI
- Huron Gastroenterology PC · Ypsilanti, MI
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus · Ypsilanti, MI
Minnesota · 11
- Essentia Health - Deer River Clinic · Deer River, MN
- Essentia Health Cancer Center · Duluth, MN
- Fairview Southdale Hospital · Edina, MN
- Essentia Health Hibbing Clinic · Hibbing, MN
- Hennepin County Medical Center · Minneapolis, MN
- Mayo Clinic in Rochester · Rochester, MN
- Regions Hospital · Saint Paul, MN
- Essentia Health Sandstone · Sandstone, MN
- Lakeview Hospital · Stillwater, MN
- Essentia Health Virginia Clinic · Virginia, MN
- Ridgeview Medical Center · Waconia, MN
Mississippi · 1
- University of Mississippi Medical Center · Jackson, MS
Missouri · 14
- Saint Francis Medical Center · Cape Girardeau, MO
- Siteman Cancer Center at Saint Peters Hospital · City of Saint Peters, MO
- Siteman Cancer Center at West County Hospital · Creve Coeur, MO
- Parkland Health Center - Farmington · Farmington, MO
- University Health Truman Medical Center · Kansas City, MO
- University of Kansas Cancer Center - Lee's Summit · Lee's Summit, MO
- Sainte Genevieve County Memorial Hospital · Sainte Genevieve, MO
- Mercy Hospital Saint Louis · St Louis, MO
- Mercy Hospital South · St Louis, MO
- Missouri Baptist Medical Center · St Louis, MO
- Siteman Cancer Center at Christian Hospital · St Louis, MO
- Siteman Cancer Center-South County · St Louis, MO
- Washington University School of Medicine · St Louis, MO
- Missouri Baptist Sullivan Hospital · Sullivan, MO
Montana · 6
- Community Hospital of Anaconda · Anaconda, MT
- Billings Clinic Cancer Center · Billings, MT
- Bozeman Health Deaconess Hospital · Bozeman, MT
- Benefis Sletten Cancer Institute · Great Falls, MT
- Logan Health Medical Center · Kalispell, MT
- Community Medical Center · Missoula, MT
Nebraska · 3
- Nebraska Medicine-Bellevue · Bellevue, NE
- Nebraska Medicine-Village Pointe · Omaha, NE
- University of Nebraska Medical Center · Omaha, NE
New Jersey · 3
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, NJ
- Memorial Sloan Kettering Monmouth · Middletown, NJ
- Memorial Sloan Kettering Bergen · Montvale, NJ
New York · 6
- Memorial Sloan Kettering Commack · Commack, NY
- Memorial Sloan Kettering Westchester · Harrison, NY
- Memorial Sloan Kettering Cancer Center · New York, NY
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center · New York, NY
- NYP/Weill Cornell Medical Center · New York, NY
- Memorial Sloan Kettering Nassau · Uniondale, NY
North Carolina · 2
- UNC Lineberger Comprehensive Cancer Center · Chapel Hill, NC
- Margaret R Pardee Memorial Hospital · Hendersonville, NC
Ohio · 11
- Strecker Cancer Center-Belpre · Belpre, OH
- Adena Regional Medical Center · Chillicothe, OH
- Columbus Oncology and Hematology Associates Inc · Columbus, OH
- Doctors Hospital · Columbus, OH
- Grant Medical Center · Columbus, OH
- Mount Carmel East Hospital · Columbus, OH
- Mount Carmel Health Center West · Columbus, OH
- Ohio State University Comprehensive Cancer Center · Columbus, OH
- Riverside Methodist Hospital · Columbus, OH
- The Mark H Zangmeister Center · Columbus, OH
- Delaware Health Center-Grady Cancer Center · Delaware, OH
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.