Last updated on May 2020

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 or squamous NSCLC, RCC, OC, or melanoma.

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 9 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
  • Cohort F: Anti-PD-1/PD-L1 antibody treated metastatic, squamous NSCLC Cohort G: Anti-PD-1/PD-L1 antibody refractory/resistant unresectable or metastatic melanoma
  • Cohort H: PD-L1 positive, aive, advanced or metastatic, non-squamous NSCLC
  • Cohort I: PD-L1 positive,naive, advanced or metastatic, squamous NSCLC

Clinical Study Identifier: NCT03666143

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Recruitment Status: Open


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