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

Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Study ID
NCT07529873
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Squamous Cell Carcinoma of Head and Neck (SCCHN)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
131 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ficerafusp + nivolumab
    Combination of Ficerafusp alfa + Nivolumab * Ficerafusp alfa 1500 mg every week * Nivolumab 240 mg every 2 weeks
  • Active Comparator: Nivolumab
    Nivolumab monotherapy • Nivolumab 240 mg every 2 weeks

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Through study completion, an average of 4 years ]

Central Contacts