TACTI-003

• Research type

  Research Study

• Full 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)

• IRAS ID

  300769

• Contact name

  Frederic Triebel

• Contact email

  tacti-003@immutep.com

• Sponsor organisation

  Immutep S.A.S.

• Eudract number

  2021-000055-39

• Clinicaltrials.gov Identifier

  NCT04811027

• Clinicaltrials.gov Identifier

  IND, 139659

• Duration of Study in the UK

  3 years, 0 months, 31 days

• Research summary

  This study is designed to obtain information on the safety and the effectiveness of an experimental product called eftilagimod alpha (short name: efti) when it is given to participants with metastatic or recurrent head and neck squamous cell cancer (HNSCC). Metastatic means that the cancer has spread to the other parts of the body. Recurrent means that the cancer has comeback after a period of time which cancer could not be detected.

  Efti in combination therapy with pembrolizumab (Brand name: Keytruda®) will be compared to pembrolizumab given alone, called monotherapy. Both products (efti and pembrolizumab) are immunotherapies. Immunotherapies are treatments where the body uses its immune system to fight cancer cells. The therapy stimulates the immune system in a targeted way with the intention to fight the cancer. Combining two immunotherapies offers a new approach in which both treatments can work together.

  Efti is an experimental product, meaning that it has not yet been authorized for use in UK.
  Pembrolizumab, which is approved in several countries including the UK, is available by prescription to treat several different cancers, but may not be approved to treat the type of cancer of the participants.

  In this phase 2 study, researchers need to collect information to help them decide whether treatment is safe and effective at treating the cancer being studied. This study will look primarily for the response effect of the tumor when both pembrolizumab and efti are given together and compare the effect when pembrolizumab is given alone. Response means that the cancers stop growing, shrink or disappear.
  

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  21/LO/0759

• Date of REC Opinion

  3 Dec 2021

• REC opinion

  Further Information Favourable Opinion