Clinical Trial: NCT03616886
Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 1| Lead Sponsor: | Jules Bordet Institute |
| Information Provided By: | Jules Bordet Institute |
| Last Update Posted: | 2026-10-07 |
Study Overview
Brief Summary
The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach.
CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade.
The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC.
A large translational research program is planned including baseline and dynamic biomarkers
Official Title
Conditions
Intervention / Treatment
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: MEDI4736
- Drug: MEDI9447
Other Study ID Numbers
- IJB-SYNERGY-012017
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Jules Bordet Institute |
| Information Provided By: | Jules Bordet Institute |
| Last Update Posted: | 2026-10-07 |
Study Overview
Brief Summary
The combination of chemotherapy with PD-1 immune checkpoint blockade agents demonstrated promising results especially in the neo-adjuvant and early metastatic setting in TNBC. However, a substantial proportion of patients do not derive benefit from this approach.
CD73 is an adenosine-generating enzyme overexpressed in several cancers and associated with poor prognosis and reduced anti-tumor immunity in TNBC. Monoclonal antibodies directed against CD73 could help to reprogram the tumor microenvironement by decreasing the adenosine mediated immunosuppression, particularly as a synergistic immunotherapeutic combination with immune checkpoint blockade.
The SYNERGY trial investigates the role of an anti-CD73 (MEDI9447) in a randomized phase II trial evaluating the efficacy and safety of the combination of chemotherapy (paclitaxel + carboplatin) with immunotherapy (durvalumab [anti-PD-L1] +/- MEDI9447 [anti-CD73]) in previously untreated locally recurrent inoperable or metastatic TNBC.
A large translational research program is planned including baseline and dynamic biomarkers
Official Title
Conditions
Intervention / Treatment
- Drug: Paclitaxel
- Drug: Carboplatin
- Drug: MEDI4736
- Drug: MEDI9447
Other Study ID Numbers
- IJB-SYNERGY-012017