NCT03680521

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

A Phase 2 Study of Sitravatinib in Combination With Nivolumab in Patients Undergoing Nephrectomy for Locally-Advanced Clear Cell Renal Cell Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Sitravatinib	Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.
DRUG	Nivolumab	Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.

Timeline

• Start date: 2018-10-10
• Primary completion: 2020-04-27
• Completion: 2023-05-18
• First posted: 2018-09-21
• Last updated: 2023-10-04
• Results posted: 2021-05-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study