Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma

• Status: Active, not recruiting
• Trial end date: 2023-05-11
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the clinical activity of sitravatinib in combination with nivolumab in patients with locally-advanced clear cell renal cell carcinoma (ccRCC) in the neoadjuvant setting prior to nephrectomy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

1. Imaging results consistent with locally-advanced RCC

2. Candidate for partial or complete nephrectomy as part of treatment plan.

3. Measurable disease per RECIST version 1.1.

4. ECOG performance status 0 or 1.

5. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Prior systemic anti-tumor treatment for RCC.

2. Patients who are receiving any other investigational agents.

3. Clinical status indicating that immediate surgery (within 6 weeks) is warranted regardless of whether neoadjuvant therapy is to be administered, as assessed by the treating surgeon.

4. Inability to undergo baseline tumor biopsy.

5. Active or prior documented autoimmune or immunocompromising conditions.

6. Uncontrolled hypertension.