Study of Sitravatinib, Nivolumab and Ipilimumab in Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Study 516-008 is an open-label Phase 1 dose escalation/Phase 1b dose expansion study evaluating the safety and tolerability, clinical activity, and PK of sitravatinib in combination with nivolumab and ipilimumab for the treatment of ccRCC and potentially other solid tumor types.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Ipilimumab; Nivolumab

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Clear-Cell Renal Cell Carcinoma (for initial cohorts under consideration)

• No prior treatment with systemic therapy (for initial cohorts under consideration)

• Adequate bone marrow and organ function

Exclusion Criteria:

• Known or suspected presence of other cancer

• Brain metastases (for initial cohorts under consideration)

• Carcinomatous meningitis

• Immunocompromising conditions

• Impaired heart function

• Active or prior documented autoimmune disease