Ficerafusp alfa

DRUG7 trials

Sponsors

Bicara Therapeutics Inc., Groupe Oncologie Radiotherapie Tete Cou, Bicara Therapeutics, Dana-Farber Cancer Institute, Groupe Oncologie Radiotherapie Tete et Cou

Conditions

HPV-Negative Squamous Cell CarcinomaHead and Neck Squamous Cell CarcinomaHead and Neck Squamous Cell Carcinoma (HNSCC)Metastatic Head and Neck Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent or Metastatic Head and Neck Squamous Cell Carcinoma.Squamous Cell Carcinoma of Head and Neck (SCCHN)Squamous Cell Carcinoma of the Head and Neck

Phase 1

Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC)

Not yet recruitingNCT07552558

Washington University School of MedicineHead and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma

Start: 2026-09-30End: 2033-11-30Target: 45Updated: 2026-08-13

Phase 2

FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC

RecruitingNCT06788990

Bicara TherapeuticsMetastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

Start: 2025-01-28End: 2029-07-01Target: 650Updated: 2026-07-17

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

RecruitingCTIS2024-519654-37-00

Bicara Therapeutics Inc.Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma.

Start: 2025-11-07Target: 191Updated: 2025-11-27

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)

Not yet recruitingCTIS2025-521437-88-00

Groupe Oncologie Radiotherapie Tete Couhead and neck squamous cell carcinoma

Target: 121Updated: 2026-03-02

Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC

RecruitingNCT07465276

Dana-Farber Cancer InstituteHead and Neck Squamous Cell Carcinoma (HNSCC), Squamous Cell Carcinoma of the Head and Neck

Start: 2026-03-26End: 2030-04-30Target: 32Updated: 2026-03-27

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

Not yet recruitingNCT07529873

Groupe Oncologie Radiotherapie Tete et CouSquamous Cell Carcinoma of Head and Neck (SCCHN)

Start: 2026-05-01End: 2030-12-01Target: 131Updated: 2026-04-14

A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC

RecruitingNCT07807163

Bicara TherapeuticsMetastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma

Start: 2026-09-01End: 2029-03-01Target: 160Updated: 2026-09-08

Related Papers

A multicenter, randomized, double-blind, phase 2/3 study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab for first-line treatment of HPV-negative, PD-L1–positive, recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): FORTIFI-HN01.

Journal of Clinical Oncology2026-05-28

Depth and durability of response with TGF-β trapping in recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC): Long-term results from two expansion cohorts of a phase 1/1b study of ficerafusp alfa plus pembrolizumab.

Journal of Clinical Oncology2026-05-27

A multicenter, randomized, double-blind, phase 2/3 study of ficerafusp alfa (BCA101) or placebo in combination with pembrolizumab for first-line treatment of PD-L1-positive, recurrent or metastatic head and neck squamous cell carcinoma: The FORTIFI-HN01 study.

Journal of Clinical Oncology2025-05-28