CompletedPhase 1

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

United States22 participantsStarted 2020-08-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Frequency of patients experiencing treatment-emergent AEs

Timeframe: Through study completion, an average of 12 months

Trial details

NCT IDNCT04518046

SponsorMirati Therapeutics Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Clear-Cell Renal Cell Carcinoma trials