Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek od 18 do 75 lat
- •Potwierdzony rak płaskonabłonkowy głowy i szyi (w jamie ustnej, krtani, gardła lub nosogardła)
- •Choroba powróciła lub się rozwinęła w ciągu 6 miesięcy po ostatniej chemioterapii
- •Guz można zmierzyć za pomocą badań obrazowych (tomografia komputerowa lub rezonans magnetyczny)
- •Pacjent w dobrym ogólnym stanie zdrowia (zdolny do wykonywania zwykłych czynności)
- •Podpisana zgoda na udział w badaniu
✗ Disqualifies
- •Rak nosogardła, zatok przynosowych, jamy nosowej lub gruczołów ślinowych
- •Rak tarczycy lub przytarczyc
- •Rak skóry
- •Dla pacjentów z rakiem gardła - dodatni wynik testu na HPV (białko p16)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- October 5, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Gustave Roussy
Villejuif, France
Trial contact
Marceline EMGOUE
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/6/2026.
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