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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 7, 2026
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Phase 1/2 Trial.
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Registry record from ClinicalTrials.gov (NCT03616886). This is a study registration, not published results. Lead sponsor: Jules Bordet Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 129 participants (ACTUAL). Conditions: Triple Negative Breast Cancer. Interventions: DRUG: Paclitaxel; DRUG: Carboplatin; DRUG: MEDI4736; DRUG: MEDI9447. Primary outcome measures: Phase I:The adverse events (AEs) , Through the Phase I, approximately 7 months; Phase II: Clinical Benefit of oleclumab in combination with chemotherapy and durvalumab by the comparing the CB rate at 24 weeks from the 1st dose of study drug administration between patients treated with or without the anti-CD73 antibody oleclumab , At 24 weeks from the 1st study drug administration. 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