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

Conditions

• Metastatic Head and Neck Squamous Cell Carcinoma
• Recurrent Head and Neck Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ficerafusp alfa — DRUG
  Investigational
• Pembrolizumab (KEYTRUDA®) — DRUG
  Immunotherapy agent used in combination with investigational agent
• Placebo — DRUG
  Placebo Control

Study Details

Ficerafusp alfa is directed against two targets, Epidermal Growth Factor Receptor (EGFR) and Transforming Growth Factor beta (TGF-β). This study intends to evaluate the safety and efficacy of ficerafusp alfa in combination with pembrolizumab versus placebo with pembrolizumab in 1L PD-L1-positive, recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC).

Key Dates

Start date

Jan 28, 2025

Status verified

May 2026

Primary completion

Apr 30, 2028

Completion

Jul 31, 2029

Study Design

Enrollment

650 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Phase 2 Arm A
  ficerafusp alfa 1500 mg QW + pembrolizumab 200 mg every 3 weeks (Q3W)
• Experimental: Phase 2 Arm B
  ficerafusp alfa 750 mg QW + pembrolizumab 200 mg Q3W
• Placebo Comparator: Phase 2 Arm C
  placebo QW + pembrolizumab 200 mg Q3W
• Experimental: Phase 3 OBD Arm
  ficerafusp alfa OBD + pembrolizumab 200 mg Q3W
• Placebo Comparator: Phase 3 Arm C
  placebo QW + pembrolizumab 200 mg Q3W

Primary Outcome Measure

Phase 2 - Incidence and severity of TEAEs, treatment-treatment emergent SAEs TEAEs leading to dose interruption, dose reduction, or permanent discontinuation. [ Time Frame: Up to 30 days post end of treatment for TEAEs (90 days for SAEs). ]

Central Contacts

• Medical Affairs
  1-617-468-4219
  [email protected]

Locations (53)

Find similar trials in Birmingham, AL

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