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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
immunotherapy
University of Hawaii
Honolulu, Hawaii, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States
Objective Response Rate
Determined by RECIST v1.1 criteria
Time frame: From date of treatment until the date of best documented response, assessed up to 36 months
Objective Response Rate (irRC)
Objective response as determined by the immune related Response Criteria
Time frame: From date of treatment until the date of best documented response, assessed up to 36 months
Duration of Response
Time from tumor response to progression
Time frame: From date of treatment until the date of progression, assessed up to 36 months
Time to progression
Time from treatment to progression of cancer
Time frame: From date of treatment until the date of progression, assessed up to 36 months
Progression free survival
Time from treatment to progression of cancer or death
Time frame: From date of treatment until the date of progression or death, assessed up to 36 months
Overall survival
Time from treatment to death
Time frame: From date of treatment until the date of death, assessed up to 36 months
AFP response
Percentage of AFP decrease from baseline to nadir
Time frame: From treatment start to documentation of AFP progression, assessed up to 36 months.
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
Tabulation of adverse events, CTCAE v4.0
Time frame: From treatment until cessation of study treatment and resolution of adverse events, assessed up to 36 months
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