NCT07529873

Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma

A Phase II Study of Ficerafusp Alfa (BCA 101) in Combination With Nivolumab in Platinum Refractory Head and Neck Squamous Cell Carcinoma Patients Who Progressed Within 6 Months After Multimodal Treatment for Locally Advanced Disease ( BICARA)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (estimated)
• Sponsor: Groupe Oncologie Radiotherapie Tete et Cou · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter study comprising two phases: a run-in phase, including only patients receiving ficerafusp alfa and nivolumab, and a randomized phase, which corresponds to a randomized, open-label, phase II comparative study. The primary objective is to compare the objective response rate (ORR) of patients with platinum refractory HNSCC with progressive disease within the 6 months after multimodal curative treatment treated with ficerafusp alfa (BCA 101) and nivolumab versus nivolumab alone. There is a strong medical justification for combining ficerafusp alfa with nivolumab (anti-PD-1) to provide additional clinical benefit to patients with platinum-refractory HNSCC who are progressing within 6 months of multimodal treatment for locally advanced disease. In the Run-in phase, patients will receive the following treatment regimens according to the study intervention plan: Combination of Ficerafusp alfa + Nivolumab * Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks In the randomized trial: * ARM A Combination of Ficerafusp alfa + Nivolumab Ficerafusp alfa 1500 mg every week Nivolumab 240 mg every 2 weeks * ARM B Nivolumab monotherapy Nivolumab 240 mg every 2 weeks

Conditions

• Squamous Cell Carcinoma of Head and Neck (SCCHN)

Interventions

Type	Name	Description
DRUG	Ficerafusp alfa	Ficerafusp alfais a bifunctional recombinant fusion protein consisting of a chimeric anti-EGFR mAb and human TGFβRII-ECD
DRUG	Nivolumab	Nivolumab is a monoclonal antibody that binds to and blocks the programmed cell death 1 receptor. It is used to treat certain cancers.

Timeline

• Start date: 2026-05-01
• Primary completion: 2030-04-01
• Completion: 2030-12-01
• First posted: 2026-04-14
• Last updated: 2026-04-14