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

NCT07529873 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2026-04-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Bicara Therapeutics

    collaborator INDUSTRY

  • Groupe Oncologie Radiotherapie Tete et Cou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2030-04-30
Completion
2030-12-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07529873 on ClinicalTrials.gov