A Study to Evaluate the Safety of Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Cancer

Completed · Phase 4

Conditions studied: Renal Cell Carcinoma

In brief

To investigate the safety of Nivolumab in combination with Ipilimumab in subjects with previously untreated advanced or metastatic Renal Cell Cancer.

Key facts

Study ID

NCT02982954

Run by

Bristol-Myers Squibb

People needed

211

Starts

2017-01-16

Expected to finish

2021-10-06

Last updated by the study team

2022-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type of Participant and Target Disease Characteristics
• Advanced or metastatic RCC
• Histologically confirmed, previously untreated (treatment-naive) RCC
• No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC
• Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease
• Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4
• Tumor tissue need be received by the central vendor (block or unstained slides). Note: Fine Needle Aspiration (FNA)and bone metastases samples are not acceptable for submission.

You may not qualify if…

• Medical Conditions
• Subjects with any active autoimmune disease or a history of known autoimmune disease
• Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured
• Known HIV or AIDS-related illness
• Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
• Prior/Concomitant Therapy
• Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy
• Prior treatment with an anti-Programmed Death (PD) -1, anti-PD-L1, anti-PD-L2, anti-cluster of differentiation 137 (CD137), or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. This includes the utilization of these agents in the neo-adjuvant or adjuvant setting.
• Anti-cancer therapy less than 28 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug.
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Alaska Urological Institute dba Alaska Clinical Research Center — Anchorage, Alaska, United States
• Ironwood Cancer And Research Centers, Pc — Chandler, Arizona, United States
• Local Institution - 0028 — Fayetteville, Arkansas, United States
• eCare — Encinitas, California, United States
• Pacific Shores Medical Group — Long Beach, California, United States
• Los Angeles Cancer Network — Los Angeles, California, United States
• UCLA Hematology Oncology — Los Angeles, California, United States
• Torrance Health Association — Redondo Beach, California, United States
• Kaiser Permanente Medical Group - Southern California — Riverside, California, United States
• Sharp Memorial Hospital — San Diego, California, United States
• Coastal Integrative Cancer Care — San Luis Obispo, California, United States
• Central Coast Med Oncology — Santa Maria, California, United States
• Florida Cancer Specialists S. — Fort Myers, Florida, United States
• University Of Miami/Sylvester Cancer Center — Miami, Florida, United States
• UF Health Cancer Center at Orlando Health — Orlando, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Emory University - Winship Cancer Institute — Atlanta, Georgia, United States
• Illinois Cancer Specialists — Niles, Illinois, United States
• Local Institution - 0012 — Fort Wayne, Indiana, United States
• Cancer Center Of Kansas — Wichita, Kansas, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Southdale Cancer Clinic — Burnsville, Minnesota, United States
• Local Institution - 0009 — Coon Rapids, Minnesota, United States
• Park Nicollet Clinic Cancer Center — Minneapolis, Minnesota, United States
• Northwest Alabama Cancer Center, Pc — Muscle Shoals, Alabama, United States

Full record on ClinicalTrials.gov

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