This Phase II trial is evaluating how safe and effective a targeted therapy (eftilagimod alpha) is when combined with immunotherapy (pembrolizumab) compared to pembrolizumab alone in people with metastatic or recurrent squamous cell carcinoma of the head and neck.
This trial is treating patients with squamous cell carcinoma of the head and neck.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have had treatment, but your cancer has come back.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Trial Identifiers
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Scientific Title
TACTI-003 (Two ACTive Immunotherapeutics): A Multicenter, Open Label, Randomized, Phase II Trial to Investigate a Soluble LAG-3 Fusion Protein, Eftilagimod Alpha (Efti; IMP321) in Combination With Pembrolizumab (PD-1 Antagonist) for First Line Treatment of Subjects With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (HNSCC)
Commercial Sponsor
Immutep S.A.S.
Summary
This trial has two cohorts. Participants in Cohort A (those with PD-L1 positive (CPS ≥1) tumours) will be randomised 1:1 to receive either eftilagimod alpha in combination with pembrolizumab (P+E) or pembrolizumab alone (P only). Participants in Cohort B (those with PD-L1 negative (CPS <1) tumours)="" will="" receive="" p="" +="" e.="" eftilagimod="" alpha="" will="" be="" administered="" 30mg="" every="" 2="" weeks="" for="" the="" first="" 4="" cycles;="" thereafter="" every="" 3="" weeks="" for="" up="" to="" 18="" cycles="" (1="" cycle="6" weeks).="" pembrolizumab="" will="" be="" administered="" 400mg="" every="" 6="" weeks="" for="" up="" to="" 18="" cycles.="" participants="" in="" cohort="" b="" (those="" with="" pd-l1="" negative="" (cps="">1)><1) tumours)="" will="" receive="" p="" +="">1)>
Recruiting Hospitals Read More