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Paclitaxel + Carboplatin + Durvalumab With or Without Oleclumab for Previously Untreated Locally Recurrent Inoperable or Metastatic TNBC

Study acronym: SYNERGY
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Mar 2025 to May 21, 2021 Completion pushed from Dec 2025 to Dec 2028 · Eligibility criteria expanded, about 72 words · Secondary endpoints: details revised at 2 of 7 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Dec 2025 to Dec 2028
    • Eligibility criteria expanded, about 72 words
    • Secondary endpoints: details revised at 2 of 7 entries
    • Study description expanded, about 9 words
  2. Primary completion date: Aug 2024 to Mar 2025 Completion date: Apr 2025 to Dec 2025v12 Show 1 more changeShow less
    • Completion date: Apr 2025 to Dec 2025
  3. Re-verified, no change to tracked fieldsv11
  4. Primary completion date: Jul 2023 to Aug 2024 Study sites: 18 to 16 · Completion date: Oct 2023 to Apr 2025v10 Show 2 more changesShow less
    • Study sites: 18 to 16
    • Completion date: Oct 2023 to Apr 2025
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 171 to confirmed 129 · Study sites: 21 to 18v8 Show 2 more changesShow less
    • Enrollment target: estimated 171 to confirmed 129
    • Study sites: 21 to 18
  2. Primary completion date: Feb 2023 to Jul 2023 Completion date: May 2023 to Oct 2023 · Eligibility criteria expanded, about 39 words · Site details revised at 5 of 21 sitesv7 Show 3 more changesShow less
    • Completion date: May 2023 to Oct 2023
    • Eligibility criteria expanded, about 39 words
    • Site details revised at 5 of 21 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Sep 2022 to Feb 2023 Completion date: Dec 2022 to May 2023 · Eligibility criteria expanded, about 53 words · Study sites revised (21)v6 Show 3 more changesShow less
    • Completion date: Dec 2022 to May 2023
    • Eligibility criteria expanded, about 53 words
    • Study sites revised (21)

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 9 to 21v5
  5. Study sites: 2 to 9 Eligibility criteria expanded, about 119 words · Study description expanded, about 6 wordsv4 Show 2 more changesShow less
    • Eligibility criteria expanded, about 119 words
    • Study description expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Dec 2018 to Dec 28, 2018v3 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 2018 to Dec 28, 2018
  7. Start date: Oct 2018 to Dec 2018v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT03616886
Lead Sponsor Jules Bordet Institute
Collaborators: AstraZeneca
Conditions Triple Negative Breast Cancer
Enrollment 129 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov