Study of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Adults Aged 18 to 75 With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating the combination of two antibodies, iparomlimab and tuvonralimab, with or without chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who have already received at least one systemic therapy. This phase II, open-label study aims to assess the treatments effectiveness and safety, including objective response rate and other measures like disease control and survival rates. The study also explores how tumor biomarkers relate to treatment response. The study starts with a safety run-in phase with about three patients to check for dose-limiting toxicities. After this, patients receive either antibody monotherapy or the antibody combination plus chemotherapy based on factors such as PD-L1 score, symptoms, disease features, and patient choice. Monotherapy involves the antibodies given intravenously every three weeks. Combination therapy adds up to six cycles of platinum chemotherapy carboplatin or cisplatin with either docetaxel or paclitaxel, followed by maintenance antibody treatment. Participants will be monitored regularly for tumor response, survival rates, and side effects throughout the study, which lasts about six months on average. Assessments include imaging to measure tumor changes according to RECIST 1.1 criteria and laboratory tests to monitor safety. Researchers track adverse events and progression-free and overall survival at six months to understand treatment impact and safety.

A Study Investigating the Efficacy and Safety of the Combination of Iparomlimab and Tuvonralimab With or Without Chemotherapy in Second-line and Subsequent Treatments for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma