Phase 1-2 Study Investigating Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of Anti-TIM-3 Monoclonal Antibody BGB-A425 in Combination with Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients with Advanced Solid Tumors
Trial ID = IRB Number
Trial Title –Automatically pulled from IRB Online – no need to complete this section
PI Name: Automatically pulled from IRB Online – no need to complete this section
The University of Virginia Cancer Center is conducting a clinical research study for adults ages 18 and over who have advanced head and neck squamous cell carcinoma (HNSCC) and Non-small cell lung cancer (NSCLC). If you join this study, you will receive a combination of two investigational anti-cancer drugs, referred to as tislelizumab (also known as BGB-A317) and BGB-A425. The purpose of this study is to see if the investigational drugs taken together will help in the treatment of HNSCC or NSCLC, and to learn about the safety of the two drugs when taken together. Each treatment cycle is 21 days, and you will receive the study drugs on the first day of each cycle.
The total treatment duration is unknown as you will receive the study drugs as long as your disease status does not worsen or no other reasons for stopping occur.
Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.
Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT03744468
Reimbursement: You will not be paid for being in this study. You will be reimbursed up to 58.5 cents per mile driven or $134 roundtrip by train, for your travel expenses. You will receive a stipend for meals, up to $25 for breakfast and lunch, and up to $50 for dinner. Hotels, up to $250 per night, and Airfare may be reimbursed if pre-approved by the sponsor.