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

• Status: Active, not recruiting
• Trial end date: 2023-03-02
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Ipilimumab; Nivolumab

Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Type of Participant and Target Disease Characteristics

1. Advanced or metastatic RCC

2. Histologically confirmed, previously untreated (treatment-naive) RCC

3. No prior systemic therapy for RCC except for one prior adjuvant or neoadjuvant therapy for completely resectable RCC

4. Measurable disease as per RECIST 1.1. Subject must have extracranial metastasis as measurable disease

5. Karnofsky Performance Status (KPS) of at least 70% for Cohort 1, 2, and 3; KPS of 50-60% for Cohort 4

6. 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.

Exclusion Criteria:

1. Medical Conditions

1. Subjects with any active autoimmune disease or a history of known autoimmune disease

2. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured

3. Known HIV or AIDS-related illness

4. Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.

2. Prior/Concomitant Therapy

1. Prior systemic treatment in the metastatic setting with Vascular epithelial growth factor(VEGF) or VEGF receptor targeted therapy

2. 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.

3. 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 could apply