Condition: Breast Carcinoma · Sponsor: Immutep S.A.S.
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer. The main questions it aims to answer are: * What is the optimal biological dose (OBD) of efti in combination with weekly paclitaxel chemotherapy? * Can efti combined with weekly paclitaxel chemotherapy prolong overall survival in participants with metastatic breast cancer if compared to weekly paclitaxel chemotherapy alone? In the first component of the trial (phase 2, lead-in) researchers will compare two groups (different dose levels of efti in combination with standard chemotherapy) to see if the treatment is safe and well tolerated and evaluate which is the optimal biological dose. In the second component of the trial (phase 3) researchers will assess if the treatment of metastatic breast cancer with the optimal biological dose of efti in combination with paclitaxel is superior compared to chemotherapy alone (placebo-controlled). The treatment concept of each trial component consists of a chemo-immunotherapy phase followed by an immunotherapy phase. In the first phase participants will be treated with efti plus paclitaxel chemotherapy or placebo plus paclitaxel chemotherapy. After completion of the chemotherapy per standard of care, participants will be treated with the study agent alone.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
| The Oncology Institute | Whittier, California, United States | — |
| The George Washington University Cancer Center | Washington D.C., District of Columbia, United States | — |
| Carolina Blood and Cancer Care Associates | Rock Hill, South Carolina, United States | — |
| Oncology Consultants | Houston, Texas, United States | — |
| The University of Texas MD Anderson Cancer Center | Houston, Texas, United States | — |
| AZ Sint-Jan Brugge Oostende av | Bruges, Belgium | — |
| Cliniques Universitaires Saint-Luc | Brussels, Belgium | — |
| Grand Hopital de Charleroi - Hopital Notre Dame | Charleroi, Belgium | — |
| Universitair Ziekenhuizen Antwerpen | Edegem, Belgium | — |
| Centre Hospitalier de l'Ardenne | Libramont, Belgium | — |
| Clinique Saint-Pierre- Ottignies | Ottignies-Louvain-la-Neuve, Belgium | — |
| ARENSIA Exploratory Medicine LLC | Tbilisi, Georgia | — |
+ 10 more locations — full list on the registry record.
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