8 completed, 3 active not recruiting, 3 terminated, 1 not yet recruiting. 9 Phase 1, 8 Phase 2, 2 Phase 3.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer Eftilagimod Alfa (Efti), Docetaxel-cyclophosphamide (TC) intravenous (i.v), Dose dense Adriamycin-cyclophosphamide (AC) i.v - Breast Cancer, HER 2 Negative Breast Cancer | Phase 2 | Not yet recruiting | George Washington University | 50 | 2026-09-01 | 2026-06-11 |
| Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004) eftilagimod alfa, carboplatin plus paclitaxel, cisplatin or carboplatin + pemetrexed - Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) | Phase 3 | Active not recruiting | Immutep S.A.S. | 756 | 2025-03-21 | 2026-03-18 |
| A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers IMP761, Placebo, keyhole limpet haemocyanin (KLH) - Healthy | Phase 1 | Completed | Immutep S.A.S. | 79 | 2024-07-17 | 2026-09-28 |
| Pembrolizumab in Combination With Eftilagimod Alpha and Radiotherapy in Neoadjuvant Treatment of Patients With Soft Tissue Sarcoma - EFTISARC-NEO Trial Pembrolizumab, Eftilagimod alfa - Neoadjuvant, Immunotherapy | Phase 2 | Active not recruiting | Maria Sklodowska-Curie National Research Institute of Oncology | 40 | 2023-07-17 | 2025-12-08 |
| A Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients to Test a New Schedule of Efti (IMP321, Eftilagimod Alpha) as Adjunctive to a Weekly Treatment Regimen of Paclitaxel Eftilagimod Alpha, Paclitaxel - Metastatic Breast Cancer | Phase 1 | Withdrawn | Immutep S.A.S. | 2023-06-01 | 2023-03-22 | |
| Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy eftilagimod alpha, Paclitaxel, placebo - Breast Carcinoma | Phase 2 / Phase 3 | Terminated | Immutep S.A.S. | 72 | 2023-05-22 | 2026-07-30 |
| Combination Study With Eftilagimod Alpha (a Soluble LAG-3 Fusion Protein) and Pembrolizumab in Patients With Recurrent or Metastatic HNSCC eftilagimod alpha, pembrolizumab (KEYTRUDA®) - HNSCC | Phase 2 | Completed | Immutep S.A.S. | 171 | 2021-08-27 | 2025-12-11 |
| Combination Study With Soluble LAG-3 Fusion Protein Eftilagimod Alpha (IMP321) and Pembrolizumab in Patients With Previously Untreated Unresectable or Metastatic NSCLC, or Recurrent PD-X Refractory NSCLC or With Recurrent or Metastatic HNSCC eftilagimod alpha, pembrolizumab (KEYTRUDA®) - NSCLC, HNSCC | Phase 2 | Completed | Immutep S.A.S. | 187 | 2019-02-21 | 2026-04-22 |
| Feasibility and Safety of IMP321 (Eftilagimod Alpha) for Advanced Stage Solid Tumors IMP321, Avelumab - Solid Tumors, Peritoneal Carcinomatosis | Phase 1 | Active not recruiting | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 83 | 2017-08-15 | 2026-02-19 |
| IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma IMP321 (eftilagimod alpha), Placebo, Paclitaxel - Adenocarcinoma Breast Stage IV | Phase 2 | Completed | Immutep S.A.S. | 242 | 2015-12-01 | 2021-10-05 |
| Immunotherapy of HLA-A2 Positive Stage II-IV Melanoma Patients 2 vaccine injections in 1 limb, 2 vaccine injections in distinct limbs, 2 "vaccine injections" in distinct limbs - Melanoma | Phase 1 / Phase 2 | Terminated | Centre Hospitalier Universitaire Vaudois | 16 | 2010-06-01 | 2020-06-11 |
| Immunization of Disease-Free Melanoma Patients With Different HLA-A2 Peptides Immunological peptides and immunological adjuvants, HLA-A2 peptides, Montanide ISA51 - Melanoma | Phase 1 / Phase 2 | Terminated | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | 19 | 2006-08-01 | 2019-03-06 |
| IMP321 Plus First-line Paclitaxel in Metastatic Breast Carcinoma IMP321 - Metastatic Breast Cancer | Phase 1 | Completed | Immutep S.A.S. | 33 | 2006-07-01 | 2010-01-07 |
| IMP321 Phase 1 Trial in Metastatic Renal Cell Carcinoma (MRCC) IMP321 - Stage IV Renal Cell Carcinoma | Phase 1 | Completed | Immutep S.A.S. | 24 | 2005-09-01 | 2010-01-07 |
| A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321 hepatitis B antigen (without alum) plus IMP321, hepatitis B antigen alone (without alum), Engerix B - Healthy | Phase 1 | Completed | Immutep S.A.S. | 48 | 2005-05-01 | 2008-04-25 |
| Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen IMP321, saline - Healthy | Phase 1 | Completed | Immutep S.A.S. | 60 | 2005-04-01 | 2008-04-24 |
Breast Neoplasms (4) · Melanoma (2) · Squamous Cell Carcinoma of Head and Neck (2) · Carcinoma, Non-Small-Cell Lung (1) · Carcinoma, Renal Cell (1) · Carcinoma, Transitional Cell (1) · Neoplasms (1) · Peritoneal Neoplasms (1) · Sarcoma (1)
soluble LAG-3 protein, human (12) · Paclitaxel (4) · pembrolizumab (4) · Adjuvants, Immunologic (1) · CP protocol (1) · Carboplatin (1) · Cisplatin (1) · Engerix-B (1) · Hepatitis B Antigens (1) · Monatide (IMS 3015) (1) · Pemetrexed (1) · Sodium Chloride (1) · avelumab (1) · keyhole-limpet hemocyanin (1) · montanide ISA 51 (1)
Belgium (5) · France (5) · Germany (4) · United States (4) · Poland (3) · Spain (3) · United Kingdom (3) · Australia (2) · Georgia (2) · Hungary (2) · Netherlands (2) · Romania (2) · Argentina (1) · Austria (1) · Brazil (1)
Didier Chassard, M.D. (2) · Bernard Escudier, M.D (1) · Katarzyna Kozak (1) · Maya Gutierrez, M.D (1) · Olivier Michielin, MD PhD (1)
PMID 19755389, PMID 20653948, PMID 26500235, PMID 39403626, PMID 41383151, PMID 41811823
2018 (1)