Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

TACTI-003 : 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)

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Head and Neck<br/>CancersCancer LocationHead and Neck
Cancers

Systemic therapy | Head and neckHead and neck

Trial Overview Read MoreRead more

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 MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

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) tumours)="" will="" receive="" p="" +="">

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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