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

Clear-Cell Renal Cell Carcinoma Clinical Trial

Official title:

A Phase 1/1b Study of Sitravatinib in Combination With Nivolumab and Ipilimumab in Patients With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma or Other Solid Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04518046
• Other study ID #: 516-008
• Status: Completed
• Phase: Phase 1
• Start date: August 11, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2024
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear-Cell Renal Cell Carcinoma

Intervention

Drug:
• Sitravatinib
Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
• Nivolumab
Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
• Ipilimumab
Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody

Locations

Country	Name	City	State
United States	MD Anderson	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients experiencing treatment-emergent AEs	Characterization of AEs by incidence, severity, timing, seriousness & relationship to study treatment	Through study completion, an average of 12 months
Secondary	Objective Response Rate (ORR) in accordance with RECIST v1.1	Frequency of patients experiencing an objective response	Through duration of study, average of 10 months
Secondary	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	Through duration of study, average of 10 months
Secondary	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	Through duration of study, average of 10 months