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

NCT ID: NCT03680521

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2023-05-18

Brief 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.

Detailed Description

Sitravatinib is a receptor tyrosine kinase inhibitor (TKI) that targets multiple closely related receptor tyrosine kinase pathways including VEGFR, PDGFR, c-KIT, MET, and the TAM family of receptors (TYRO3, AXL, and MER). Nivolumab is a monoclonal antibody directed against PD-1 and blocks the interaction between PD-1 and its ligands, thereby releasing PD-1-mediated inhibition of T-cell proliferation (including cytotoxic CD8+ T-cells) and cytokine production. Together, sitravatinib and nivolumab may cooperate to elicit greater anti-tumor activity than either agent alone, as sitravatinib is predicted to enhance several steps in the cancer immunity cycle that may augment the efficacy of nivolumab.

Conditions

Clear Cell Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sitravatinib and nivolumab

Sitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks prior to planned nephrectomy.

Group Type: EXPERIMENTAL

Sitravatinib

Intervention Type: DRUG

Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.

Nivolumab

Intervention Type: DRUG

Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.

Interventions

Sitravatinib

Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.

Intervention Type: DRUG

Nivolumab

Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

516-002

Identifier Type: -

Identifier Source: org_study_id