At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 122 enrolled
Drug / intervention
niraparib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating niraparib and pembrolizumab for Neoplasms and 8 related conditions. Completed, enrolled 122 participants across 30 sites.
Detailed Summary
This Phase 1/2 study will evaluate the safety and efficacy of combination treatment with niraparib and pembrolizumab (MK-3475) in patients with advanced or metastatic triple-negative breast cancer or recurrent ovarian cancer. (KEYNOTE-162)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms, Triple Negative Breast Cancer, Ovarian Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Stage IV Breast Cancer, Fallopian Tube Cancer, Peritoneal Cancer
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartApr 2016
Primary CompletionMay 2018
Study CompletionSep 2021
TodayJul 2026
First PostedJan 18, 2016
Enrollment StartApr 15, 2016
Primary CompletionMay 14, 2018
Study CompletionSep 17, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 10.5 years ago
Interventions
niraparibdrug
pembrolizumabbiological