Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refract… (NCT07529873) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma
131 participantsStarted 2026-05
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient or legally authorized representative, if applicable, has signed and dated informed consent form (ICF) indicating that the patient (or legally authorized representative, if applicable) has been informed of all the pertinent aspects of the study prior to enrollment and the patient must be willing to comply with all study procedures for the duration of the study.
* Patient is \>18 years, ≤75 years of age on the day the ICF is signed.
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 (see Appendix 1).
* Histologically or cytologically confirmed squamous cell carcinoma of head and neck (HNSCC). Eligible primary tumor locations are oral cavity, larynx hypopharynx, or oropharynx (OPSCC).
* Local, regional or metastatic progression within 6 months after the last dose of platinum in a multimodal strategy for locally advanced stage, not amenable to salvage surgery in case of local or regional progression.
Specification regarding inclusion criterion no. 05 : Progression is not assessed as per RECIST. Any of the following will be considered as progression:
* A positive biopsy 3 months after the end of radiotherapy given with curative intent
* Appearance of any new lesion (e.g.: metastases or lymph nodes)
* Any increase in tumor size
* Any persisting tumor (confirmed with a biopsy) not amenable to salvage surgery
* For OPSCC patients, a pathological report determination of human papillomavirus (HPV) status by p16 expr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: Through study completion, an average of 4 years