deltatrials
Terminated PHASE2 INTERVENTIONAL 1-arm NCT03955471

Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Participants With Platinum Resistant Ovarian Cancer (MOONSTONE)

A Phase 2 Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of the Combination of Niraparib and Dostarlimab (TSR-042) in Patients With Platinum-Resistant Ovarian Cancer (MOONSTONE)

Sponsor: Gynecologic Oncology Group

Conditions Ovarian Neoplasms
Interventions Dostarlimab Niraparib
Updated 16 times since 2019 Last updated: Aug 16, 2022 Started: Oct 3, 2019 Primary completion: Aug 18, 2021 Completion: Jan 12, 2022
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The study will not resume based on the results of a planned interim analysis that showed futility

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A PHASE2 clinical study on Ovarian Neoplasms, this trial is terminated or withdrawn. The trial is conducted by Gynecologic Oncology Group and has accumulated 16 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jun 2019 – ~Dec 2019 · 6 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Jun 2020 · 4 months · monthly snapshot~Jun 2020 – ~Aug 2020 · 2 months · monthly snapshot~Aug 2020 – ~Sep 2020 · 31 days · monthly snapshot~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Jul 2024 · 22 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 24 months · monthly snapshot

Change History

16 versions recorded

  1. Sep 2024 — Present [monthly]

    Terminated PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE2

  3. Sep 2022 — Jul 2024 [monthly]

    Terminated PHASE2

  4. Mar 2022 — Sep 2022 [monthly]

    Terminated PHASE2

    Status: Active Not Recruiting → Terminated

  5. Jan 2022 — Mar 2022 [monthly]

    Active Not Recruiting PHASE2

▶ Show 11 earlier versions

  1. Nov 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE2

  2. Oct 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE2

  3. Sep 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: Suspended → Active Not Recruiting

  4. Jan 2021 — Sep 2021 [monthly]

    Suspended PHASE2

  5. Nov 2020 — Jan 2021 [monthly]

    Suspended PHASE2

    Status: Recruiting → Suspended

  6. Sep 2020 — Nov 2020 [monthly]

    Recruiting PHASE2

  7. Aug 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  8. Jun 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

  9. Feb 2020 — Jun 2020 [monthly]

    Recruiting PHASE2

  10. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  11. Jun 2019 — Dec 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Gynecologic Oncology Group
  • Tesaro, Inc.
Data source: Tesaro, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Austin, United States , Boston, United States , Burlington, United States , Charlottesville, United States , Chattanooga, United States , Cleveland, United States , Deerfield Beach, United States , Duarte, United States , Durham, United States , Eugene, United States and 15 more locations