Last updated on June 2019

A Phase 1b Study to Assess Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors.

Brief description of study

This is an open-label, multicenter, non-randomized Phase 1b clinical trial for patients with histologically or cytologically confirmed locally advanced or metastatic tumors including non- squamous NSCLC, RCC, or OC.

Detailed Study Description

All patients will receive sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks until occurrence of PD, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor.

There will be 5 cohorts in the study. Approximately 20 patients will be enrolled into each cohort. The patients will be enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment.

  • Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC
  • Cohort B: Anti-PD-1/PD-L1 antibody nave metastatic, non-squamous NSCLC
  • Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC
  • Cohort D (China-only): Metastatic or advanced RCC without prior systemic therapy
  • Cohort E: Anti-PD-1/PD-L1 antibody nave recurrent and platinum resistant Epithelial OC A Safety Monitoring Committee (SMC) will review the safety, tolerability, and pharmacology data from the initial 6 patients (regardless of assigned cohort) that complete the first treatment cycle in Australia. Recruitment will be on hold in Australia until these data have been reviewed. For participating China sites only, the initial 6 patients enrolled in China regardless of assigned cohort will have their safety, tolerability, and pharmacology data reviewed by the SMC. Recruitment in China only will be on hold until the data have been reviewed. The SMC may assess the combination regimen as safe, but may also decide to evaluate a dosing regimen that was not predefined or not previously studied, if evaluation of toxicity at such a dose is desired.

Clinical Study Identifier: NCT03666143

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Recruitment Status: Open

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