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Retifanlimab Combinations in First-Line PD-L1-Positive Recurrent/Metastatic SCCHN
NCT05287113Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2022
- Primary completion
- Mar 2025
- Countries
- 14
- Sponsor
- Incyte
- Modality
- Monoclonal Antibodies
- Conditions
- squamous cell carcinoma of the head and neck (HNSCC)
01
Overview
Phase 2, randomised, double-blind trial of tuparstobart and verzistobart in squamous cell carcinoma of the head and neck (HNSCC) (3 arms), sponsored by Incyte. Primary endpoint: Progression-free Survival up to 738 days. Started Nov 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Retifanlimab Monotherapy
Retifanlimab IV q4w + Placebos IV q2w
Retifanlimab + INCAGN02385
Retifanlimab IV q4w + INCAGN02385 IV q2w + Placebo IV q2w
Retifanlimab + INCAGN02385 + INCAGN02390
Retifanlimab IV q4w + INCAGN02385 IV q2w + INCAGN02390 IV q2w
03
Who it enrols
Patients with systemic therapy-naive, PD-L1-positive (CPS >= 1) recurrent/metastatic squamous cell carcinoma of the head and neck (oropharynx, oral cavity, hypopharynx, larynx) with ECOG 0-1 and no prior checkpoint inhibitor therapy.
04
Endpoints
Primary
Progression-free Survival
Secondary
Objective Response
Duration of Response
Disease Control
Overall Survival
Number of Participants With Treatment-emergent Adverse Events
Number of Participants With TEAEs Leading to Treatment Interruption, Dose Delay, and Withdrawal of Study Treatment
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