Phase 2Recruiting
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma (N'FORCE)
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)
- Sponsor
- Groupe Oncologie Radiotherapie Tete et Cou (Academic or other)
- Enrollment
- 131 planned
- Conditions
- Squamous Cell Carcinoma of Head and Neck (SCCHN)
- Interventions
- Ficerafusp alfa; Nivolumab
- Ages
- adults, older adults
- Registry
- NCT07529873
Full record on ClinicalTrials.gov
From the registry
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…
Primary outcomes
- Objective response rate (ORR)
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started