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

Sponsor:

Bicara Therapeutics

Sponsor Study ID:

BCA101X301

CTO #:

103951

NCT Number:

NCT06788990

Phase:

II

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Larynx; Lip, Oral Cavity and Pharynx

Study Objectives:

To identify optimal biological dose by assessing safety and tolerability of ficerafusp alfa in subjects randomized to ficerafusap alpha 1500 mg once weekly with pembrolizumab (treatment arm A) and ficerafusp alfa 750 mg QW pembrolizumab. Assessing antitumor activity of ficerafusp alfa in subjects randomized to ficerafusp alfa 1500 mg QW with pembrolizumab (treatment Arm A) and ficerafusp alfa 750 mg QW and pembrolizumab (treatment Arm B).

eConsent:

Not available

Study Documents:

Open Study Documents
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