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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Tesaro, Inc.
Study ID
NCT02657889
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • niraparib — DRUG
  • pembrolizumab — BIOLOGICAL

Study Details

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)

Key Dates

Start date
Apr 15, 2016
Status verified
Nov 2022
Primary completion
May 14, 2018
Completion
Sep 17, 2021

Study Design

Enrollment
122 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: niraparib plus pembrolizumab
    Phase 1: Dose-escalation: ascending doses of niraparib up to 300mg/day orally (PO) on Days 1-21 and pembrolizumab 200mg intravenously (IV) on Day 1 of each 21-day cycle Phase 2: niraparib (recommended Phase 2 dose) in combination with pembrolizumab 200mg IV on Day 1 of each 21-day cycle

Primary Outcome Measure

Phase 1: Number of Participants Reporting Dose-Limiting Toxicities (DLTs) [ Time Frame: During Cycle 1, ie, during the first 21 days of treatment ]

Locations (30)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBirminghamAlabama35249-
GSK Investigational SitePhoenixArizona85054-
GSK Investigational SiteScottsdaleArizona85258-
GSK Investigational SiteLos AngelesCalifornia90048-
GSK Investigational SiteSan FranciscoCalifornia94115-
GSK Investigational SiteStanfordCalifornia94305-
GSK Investigational SiteWashington D.C.District of Columbia20007-
GSK Investigational SiteDeerfield BeachFlorida33442-
GSK Investigational SiteJacksonvilleFlorida32224-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteOrlandoFlorida32804-
GSK Investigational SiteChicagoIllinois60637-
GSK Investigational SiteCovingtonLouisiana70433-
GSK Investigational SiteBostonMassachusetts02111-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteBostonMassachusetts02115-
GSK Investigational SiteBurlingtonMassachusetts01805-
GSK Investigational SiteDetroitMichigan48201-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteMorristownNew Jersey07962-
GSK Investigational SiteNew YorkNew York10065-
GSK Investigational SiteChapel HillNorth Carolina27514-
GSK Investigational SiteCharlotteNorth Carolina28204-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteGermantownTennessee38138-
GSK Investigational SiteNashvilleTennessee37203-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteCharlottesvilleVirginia22903-
GSK Investigational SiteSeattleWashington98109-

Find similar trials in Birmingham, AL

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
GSK Investigational Site· Birmingham, ALGSK Investigational Site· Phoenix, AZGSK Investigational Site· Scottsdale, AZGSK Investigational Site· Los Angeles, CAGSK Investigational Site· San Francisco, CAGSK Investigational Site· Stanford, CA

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