Spots Global Cancer Trial Database for TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer

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Trial Identification

Brief Title: TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer

Official Title: Phase II Study of TSR-022 (Cobolimab) in Combination With TSR-042 (Dostarlimab) for the Treatment of Advanced Hepatocellular Carcinoma

Study ID: NCT03680508

Conditions

Adult Primary Liver Cancer

Advanced Adult Primary Liver Cancer

Localized Unresectable Adult Primary Liver Cancer

Interventions

TSR-022 and TSR-042

Study Description

Brief Summary: TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) may stop the growth of tumor cells by allowing the immune system to attack the cancer. This phase II trial is studying how well TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) work in combination in treating patients with locally advanced or metastatic liver cancer.

Detailed Description: PRIMARY OBJECTIVES: I. To assess the objective response rate (ORR) as determined by RECIST v1.1 of advanced hepatocellular cancer (HCC) patients treated with TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody). SECONDARY OBJECTIVES: I. To determine the ORR as determined by the immune related Response Criteria (irRC), duration of response (DOR), time to progression (TTP), progression free survival (PFS), overall survival (OS), and alpha-fetoprotein (AFP) response of study participants. II. To evaluate the safety profile of treated patients. OUTLINE: Patients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 9 weeks.