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:
+ 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 completed enrollment in 2021. This 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 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 evaluating 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 completed enrollment in 2023 and is evaluating 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 also determining 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.
Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT03252938
+ INSIGHT-005
INSIGHT-005 is a Phase I clinical trial in patients with solid tumours evaluating the safety and efficacy of eftilagimod alpha (“efti”) in combination with BAVENCIO® (avelumab) in up to 30 patients with metastatic urothelial carcinoma.
INSIGHT-005 will be conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt.
Contact details can be found here: https://clinicaltrials.gov/ct2/show/NCT03252938
+ EFTISARC-NEO
EFTISARC-NEO is an investigator-initiated, open-label Phase II trial evaluating eftilagimod alpha (efti) in combination with pembrolizumab and radiotherapy in up to 40 soft tissue sarcoma (STS) patients in the neoadjuvant (prior to surgery) setting.
The trial is led by Co-Principal Investigators, Katarzyna Kozak, M.D., Ph.D., and Paweł Sobczuk, M.D., Ph.D., medical oncologists at the Department of Soft Tissue/Bone Sarcoma and Melanoma at the Maria Skłodowska-Curie National Research Institute of Oncology, in Warsaw, Poland.
Contact details can be found here: https://clinicaltrials.gov/study/NCT06128863
+ AIPAC-003
AIPAC-003 (Active Immunotherapy and PAClitaxel) is an integrated Phase II/III trial to evaluate eftilagimod alpha (“efti”) in combination with paclitaxel for the treatment of metastatic HER2-neg/low breast cancer (MBC). Patient enrolment has been completed in the randomised Phase II portion of the clinical trial.
Contact details can be found here: https://clinicaltrials.gov/study/NCT05747794