Phase 2 Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or With Anti-PD-1 Pucotenlimab Followed by Chemoradiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating treatments for patients with locally advanced squamous cell carcinoma of the head and neck LA-HNSCC who require chemoradiotherapy. This Phase 2 trial compares the effects of an induction treatment using EGFR-ADC MRG003 alone versus a combination of EGFR-ADC MRG003 with the anti-PD-1 drug Pucotenlimab before chemoradiotherapy. The study aims to assess the objective response rate of these treatments to better understand their impact on this condition. Participants are assigned to one of two groups. One group receives three cycles of EGFR-ADC MRG003 alone as induction treatment over 9 weeks, followed by chemoradiotherapy lasting 7 weeks. The other group receives three cycles of both Pucotenlimab and MRG003 combined during the induction period, then chemoradiotherapy, followed by adjuvant Pucotenlimab treatment for 24 weeks starting about one month after chemoradiotherapy ends. Chemoradiotherapy begins within 28 days after completing the induction cycles. During the study, participants undergo imaging assessments to evaluate their tumor response. Researchers will measure the primary outcome, which is the objective response rate approximately 20 months after the first patient is included. Secondary outcomes include progression-free survival, failure-free survival, and overall survival, all assessed one year after the last patient is included. The total participation duration includes induction, chemoradiotherapy, and follow-up for outcome measurement, with safety and response closely monitored throughout.

Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck