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

Mirati Therapeutics Inc.22 enrolled

Overview

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.

Sitravatinib is a spectrum-selective receptor tyrosine kinase (RTK) inhibitor that inhibits several closely related RTKs including the TAM family (Tyro3/Axl/MERTK), VEGFR2, KIT, and MET. NIVO/IPI are monoclonal antibodies (mAbs) that inhibit the immune checkpoint proteins programmed death receptor-1 (PD-1) and cytotoxic T- lymphocyte antigen-4 (CTLA-4), respectively. The current study is designed to evaluate the triple combination of sitravatinib plus NIVO/IPI in patients with solid tumor malignancies that have shown favorable responses to NIVO/IPI combinations in previous clinical trials. Combining sitravatinib and NIVO/IPI is predicted to have complementary effects in triggering a tumor-directed immune response.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Clear-Cell Renal Cell Carcinoma

Interventions

SitravatinibDRUG

Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases

NivolumabDRUG

Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody

IpilimumabDRUG

Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson

Houston, Texas, United States

Outcomes

Primary Outcomes

Frequency of patients experiencing treatment-emergent AEs

Characterization of AEs by incidence, severity, timing, seriousness \& relationship to study treatment

Time frame: Through study completion, an average of 12 months

Secondary Outcomes

Objective Response Rate (ORR) in accordance with RECIST v1.1

Frequency of patients experiencing an objective response

Time frame: Through duration of study, average of 10 months

Duration of Response (DOR)

Time in months from date of the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause in the absence of documented PD

Time frame: Through duration of study, average of 10 months

Progression-free Survival (PFS)

Time from date of first study treatment to first PD or death due to any cause in the absence of documented PD

Time frame: Through duration of study, average of 10 months

Data from ClinicalTrials.gov

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