NCT03666143

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

A Phase 1b Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: BeiGene · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was an open-label, multicenter, non-randomized Phase 1b clinical trial for participants with histologically or cytologically confirmed locally advanced or metastatic tumors including non-squamous or squamous non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), ovarian cancer (OC), or melanoma.

Detailed description

All participants received sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg intravenously (IV) once every 3 weeks until occurrence of progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor. Participants were enrolled according to their tumor type and prior anti-programmed cell death protein-1 (PD-1)/PD-L1 antibody treatment into the following cohorts: * Cohort A: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic, non-squamous NSCLC * Cohort B: Anti-PD-1/PD-L1 antibody naïve metastatic, non-squamous NSCLC * Cohort C: Anti-PD-1/PD-L1 antibody refractory/resistant metastatic or advanced RCC * Cohort D: Metastatic or advanced RCC without prior systemic therapy * Cohort E: Anti-PD-1/PD-L1 antibody naïve 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, locally advanced or metastatic, non-squamous NSCLC without prior systemic treatment in the metastatic setting * Cohort I: PD-L1 positive, locally advanced or metastatic, squamous NSCLC without prior systemic treatment in the metastatic setting

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Sitravatinib	Administered orally as a capsule
DRUG	Tislelizumab	Administered intravenously

Timeline

• Start date: 2018-11-01
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2018-09-11
• Last updated: 2024-11-04
• Results posted: 2024-06-17

Locations

19 sites across 2 countries: Australia, China

Regulatory

• FDA-regulated drug study