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Immunotherapy Clinical Trials.


Immutep is passionate about researching and developing new opportunities to increase wellbeing for those patient’s experiencing the detrimental effects of cancer and other autoimmune diseases. Our lead product, eftilagimod alpha (efti or IMP321) is currently under clinical development in four separate clinical studies to determine the safety, tolerability and efficacy of the product.

Participation in Immutep clinical trials is always based on the patient’s own decision. For further information on these immunotherapy clinical trials, please contact your treating physician.

Current Immutep Immunotherapy Clinical Trials:

+ TACTI-002 (Two ACTive Immunotherapies)

TACTI-002 (Two ACTive Immunotherapies, also designated KEYNOTE-798) is a Phase II clinical trial which commenced in 2018 and is currently recruiting patients. This ongoing trial is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada).

The study is evaluating the combination of efti with MSD’s KEYTRUDA® (pembrolizumab) in up to 183 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT03625323

+ TACTI-003

TACTI-003 is a Phase IIb Clinical Trial in 1st line Head and Neck Cancer. Subject to ethical and regulatory approval, it will evaluate efti in combination with MSD’s KEYTRUDA® (pembrolizumab) as a first line therapy in unresectable recurrent or metastatic HNSCC patients with PD-L1 negative and PD-L1 positive (CPS ≥1) tumours.

The study will evaluate the safety and efficacy of efti in combination with pembrolizumab, compared to pembrolizumab alone in 1st line metastatic or recurrent HNSCC patients with PD-L1 positive (CPS ≥1) tumours (cohort A), and determine the efficacy and safety of efti plus pembrolizumab in patients with PD-L1 negative tumours (CPS <1) (cohort B).

The primary endpoint of the study is the Overall Response Rate (ORR) according to RECIST 1.1. iRECIST will be used for treatment decisions

Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT03625323

+ INSIGHT-003

INSIGHT-003 is an investigator-initiated trial conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt.

The trial is an expansion into triple combination therapy consisting of efti in conjunction with an existing approved standard of care combination of chemotherapy and anti-PD-1therapy. The first interim results are expected in 2022.

Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT03252938

+ INSIGHT-005

INSIGHT -005 is a Phase I/IIa clinical trial in patients with solid tumours.

The trial evaluates the feasibility, safety and efficacy of eftilagimod alpha, when given in combination with bintrafusp alfa (M7824), an investigational bifunctional fusion protein immunotherapy being jointly developed by Merck, Darmstadt, Germany and GlaxoSmithKline.

Bintrafusp alfa aims to block two immunosuppressive pathways, TGF-β and PD-L1, while efti activates antigen presenting cells, via the LAG-3 – MHC II pathway. The first data is expected to be delivered in 2022.