Patient & Participant Contact

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:

 

+ AIPAC (Active Immunotherapy PAClitaxel)

Active Immunotherapy PAClitaxel (AIPAC) is a Phase II b clinical trial in metastatic breast cancer (MBC) based on our LAG-3 technology by combining taxane-based chemotherapy called paclitaxel and with eftilagimod alpha (LAG-3Ig or IMP321) as an immunotherapy. This combination is aimed to boost the immune response against tumour cells compared to chemotherapy alone. In AIPAC, 226 hormone receptor positive metastatic breast cancer patients are randomized 1:1 to treatment A (Paclitaxel chemotherapy plus Placebo) or treatment B (Paclitaxel chemotherapy plus eftilagimod alpha i). Thereafter, patients will pass over to the maintenance phase.

This study is ongoing in seven European countries.
Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT02614833

+ TACTI-mel (Two ACTive Immunotherapeutics in melanoma)

Two ACTive Immunotherapeutics in melanoma (TACTI-mel) is a Phase I safety and dose finding combination clinical trial of Eftilagimod alpha together with pembrolizumab (PD-1 blocking antibody also known as Keytruda). The study was based on the combination of two immunotherapy to enhance the immune response by activated T cells. TACTI-mel  enrolled up to 18 patients with locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma with ascending subcutaneous doses of eftilagimod alpha up to 30 mg per injection.

Patients having a suboptimal response or having had disease progression with pembrolizumab monotherapy were eligible for the study and received the combination of pembrolizumab plus eftilagimod alpha.

This study was completed in Australia.
Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT02676869

+ 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

+ INSIGHT-004

Immutep’s INSIGHT-004 trial (also known as INSIGHT Stratum D) is an ongoing Phase I clinical trial which the Company commenced in 2019 and is currently recruiting patients. It is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt.

INSIGHT-004 is being conducted under Immutep’s collaboration with Merck KGaA and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab, a human anti-PD-L1 antibody, in 12 patients with solid cancers. Avelumab is co-developed and co-commercialised by Merck KGaA, Darmstadt, Germany and Pfizer Inc.

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