A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination With INCAGN02385 (Anti–LAG-3) and INCAGN02390 (Anti–TIM-3) as First-Line Treatment in Participants With PD-L1–Positive (CPS = 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

UVA Tracking #
HSR220252
Principal Investigator
Varinder Kaur
Contact
Contact Phone
Official Trial Title
A Randomized, Double-Blind, Multicenter, Phase 2 Study of Retifanlimab in Combination with INCAGN02385 (Anti-LAG-3) and INCAGN02390 (Anti-TIM-3) as First-Line Treatment in Participants with PD-LI-Positive (CPS = 1) Recurrent/ Metastatic Squamous Cell Carc
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The purpose of the study is to evaluate the efficacy and safety of the combination of retifanlimab and INCAGN02385 (treatment group 2), and retifanlimab and INCAGN02385 and INCAGN02390 (treatment group 3), compared to retifanlimab alone (treatment group 1) as first-line treatment for patients with SCCHN. This study is double-blind, which means that during the study you and your study doctor will not know which drugs you are receiving. Your study doctor can find out in case of emergency. This study is also randomized, which means you will be randomly assigned (like drawing straws) to 1 of 3 treatment groups (described above).

You may receive treatment with the study drugs for up to 2 years as long as your cancer is not getting worse or you do not have serious side effects. Your total participation in the study may last up to about 4 years including long term follow-up. You will receive the study drugs via IV.

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/NCT05287113

uvacancertrials@hscmail.mcc.virginia.edu

Compensation

You will be paid $65 per visit. Additionally, the study team may arrange for your hotel or you may reimbursed by check up to $175 per night for a hotel.