Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT02657889

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer (TOPACIO)

Phase 1/2 Clinical Study of Niraparib in Combination With Pembrolizumab (MK-3475) in Patients With Advanced or Metastatic Triple-Negative Breast Cancer and in Patients With Recurrent Ovarian Cancer

Sponsor: Merck Sharp & Dohme LLC

Conditions Advanced Breast Cancer Breast Cancer Fallopian Tube Cancer Metastatic Breast Cancer Neoplasms Ovarian Cancer Peritoneal Cancer Stage IV Breast Cancer Triple Negative Breast Cancer

Interventions niraparib pembrolizumab

Updated 23 times since 2017 Last updated: Nov 7, 2022 Started: Apr 15, 2016 Primary completion: May 14, 2018 Completion: Sep 17, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Advanced Breast Cancer and Breast Cancer and is currently completed. Merck Sharp & Dohme LLC leads this study, which shows 23 recorded versions since 2016 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

Change History

23 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1/PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1/PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1/PHASE2

Phase: PHASE1_PHASE2 → PHASE1/PHASE2
Dec 2022 — Jul 2024 [monthly]

Completed PHASE1_PHASE2
Jun 2022 — Dec 2022 [monthly]

Completed PHASE1_PHASE2

▶ Show 18 earlier versions

Dec 2021 — Jun 2022 [monthly]

Completed PHASE1_PHASE2
Nov 2021 — Dec 2021 [monthly]

Completed PHASE1_PHASE2

Status: Active Not Recruiting → Completed
Oct 2021 — Nov 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2
Sep 2021 — Oct 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2

Phase: PHASE2 → PHASE1_PHASE2
May 2021 — Sep 2021 [monthly]

Active Not Recruiting PHASE2

Phase: PHASE1_PHASE2 → PHASE2
Feb 2021 — May 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2
Jan 2021 — Feb 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2
Mar 2020 — Jan 2021 [monthly]

Active Not Recruiting PHASE1_PHASE2
Oct 2019 — Mar 2020 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Unknown Status → Active Not Recruiting
Sep 2019 — Oct 2019 [monthly]

Unknown Status PHASE1_PHASE2

Status: Active Not Recruiting → Unknown Status
Jun 2018 — Sep 2019 [monthly]

Active Not Recruiting PHASE1_PHASE2
Mar 2018 — Jun 2018 [monthly]

Active Not Recruiting PHASE1_PHASE2

Status: Recruiting → Active Not Recruiting
Sep 2017 — Mar 2018 [monthly]

Recruiting PHASE1_PHASE2
Aug 2017 — Sep 2017 [monthly]

Recruiting PHASE1_PHASE2
May 2017 — Aug 2017 [monthly]

Recruiting PHASE1_PHASE2
Mar 2017 — May 2017 [monthly]

Recruiting PHASE1_PHASE2
Feb 2017 — Mar 2017 [monthly]

Recruiting PHASE1_PHASE2
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1_PHASE2

First recorded

Apr 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Merck Sharp & Dohme LLC
Tesaro, Inc.

Data source: Tesaro, Inc.

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

Study Locations

Birmingham, United States , Boston, United States , Burlington, United States , Chapel Hill, United States , Charlotte, United States , Charlottesville, United States , Chicago, United States , Cleveland, United States , Covington, United States , Deerfield Beach, United States and 18 more locations