5 recruiting, 1 not yet recruiting. 5 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Recruiting 4, Not yet recruiting 1 |
| Phase 1 | 2 | Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) Hypofractionated Stereotactic Body Radiotherapy (SBRT), Pembrolizumab, Ficerafusp alfa - Head and Neck Squamous Cell Carcinoma, HPV-Negative Squamous Cell Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | Washington University School of Medicine | 45 | 2026-09-30 | 2026-08-13 |
| A Study Evaluating Ficerafusp Alfa (BCA101) QW in Combination With Pembrolizumab vs Alternative Ficerafusp Alfa Dosing in 1L R or M HNSCC Ficerafusp alfa, Pembrolizumab (KEYTRUDA®) - Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 2 | Recruiting | Bicara Therapeutics | 160 | 2026-09-01 | 2026-10-13 |
| Neoadjuvant Ficerafusp Alfa With Pembrolizumab in Resectable SCC Ficerafusp alfa, Pembrolizumab - Head and Neck Squamous Cell Carcinoma (HNSCC), Squamous Cell Carcinoma of the Head and Neck | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 32 | 2026-03-26 | 2026-03-27 |
| Phase II Study of Ficerafusp Alfa in Combination With Nivolumab in Patients With Platinum-refractory Head and Neck Squamous Cell Carcinoma Ficerafusp alfa, Nivolumab - Squamous Cell Carcinoma of Head and Neck (SCCHN) | Phase 2 | Recruiting | Groupe Oncologie Radiotherapie Tete et Cou | 131 | 2026-03-03 | 2026-10-05 |
| FORTIFI-HN01: A Study of Ficerafusp Alfa (BCA101) or Placebo in Combination With Pembrolizumab in First-Line PD-L1-pos, R or M HNSCC Ficerafusp alfa, Pembrolizumab (KEYTRUDA®), Placebo - Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 2 / Phase 3 | Recruiting | Bicara Therapeutics | 650 | 2025-01-28 | 2026-10-02 |
| Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors BCA101, Pembrolizumab - Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal | Phase 1 | Recruiting | Bicara Therapeutics | 473 | 2020-06-01 | 2026-10-06 |
Squamous Cell Carcinoma of Head and Neck (6) · Head and Neck Neoplasms (4) · Camurati-Engelmann Syndrome (2) · Carcinoma, Squamous Cell (2) · Laryngeal Diseases (2) · Carcinoma, Ovarian Epithelial (1) · Colorectal Neoplasms (1) · Hypopharyngeal Neoplasms (1) · Jaw Neoplasms (1) · Laryngeal Neoplasms (1) · Lip Neoplasms (1) · Mouth Neoplasms (1) · Oropharyngeal Neoplasms (1) · Pancreatic Neoplasms (1) · Tongue Neoplasms (1)
pembrolizumab (5) · Nivolumab (1)
United States (5) · Australia (2) · Canada (2) · France (2) · Argentina (1) · Austria (1) · Belgium (1) · Brazil (1) · Czechia (1) · Germany (1) · Greece (1) · India (1) · Ireland (1) · Israel (1) · Italy (1)
Glenn Hanna (1) · Sana Karam, MD, PhD (1) · Sidharth Puram, MD, PhD (1)