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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Tesaro, Inc.
Study ID
NCT03955471
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib is a potent, orally active poly (adenosine diphosphate-ribose) polymerase (PARP)-1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription factors.
  • Dostarlimab — DRUG
    TSR-042 is a humanized monoclonal antibody that binds with high affinity to programmed cell death-1 (PD-1) resulting in inhibition of binding to programmed cell-death receptor ligands 1 and 2 (PD-L1 and PD-L2).

Study Details

This is an open-label, single-arm Phase 2 study to evaluate the efficacy and safety of combination of niraparib and dostarlimab (TSR-042) in participants with advanced, relapsed, high-grade ovarian, fallopian tube, endometrioid, clear cell ovarian or primary peritoneal cancer without known breast cancer susceptibility gene (BRCA) mutation who have platinum-resistant disease and who have also been previously treated with bevacizumab.

Key Dates

Start date
Oct 3, 2019
Status verified
Aug 2022
Primary completion
Aug 18, 2021
Completion
Jan 12, 2022

Study Design

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

Arms

  • Experimental: Niraparib+Dostarlimab (TSR-042)
    Participants with body weight ≥77 kilogram (kg) and platelet count ≥150,000/microliter (μL) at baseline were administered Niraparib 300 milligram (mg) once daily (QD) and participants with body weight \<77 kg or platelet count \<150,000/μL at baseline were administered Niraparib 200 mg QD. Niraparib was administered continuously until Progressive disease (PD) or toxicity. Dostarlimab (TSR-042) was administered as an intravenous (IV) infusion of 500 mg once every three weeks (Q3W) from Cycle 1 Day 1 through Cycle 4. Beginning at Cycle 5, Dostarlimab (TSR-042) was administered via an IV infusion of 1000 mg on Day 1 of each 6-week cycle until PD or toxicity, up to 27 months.

Primary Outcome Measure

Objective Response Rate (ORR) in Participants With Platinum-resistant Ovarian Cancer (PROC) [ Time Frame: Up to approximately 22 months ]

Locations (27)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteScottsdaleArizona85258-
GSK Investigational SiteDuarteCalifornia91010-
GSK Investigational SiteNewport BeachCalifornia92663-
GSK Investigational SiteOrangeCalifornia92868-
GSK Investigational SiteSolvangCalifornia93463-
GSK Investigational SiteDeerfield BeachFlorida33442-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteOrlandoFlorida32804-
GSK Investigational SiteTampaFlorida33612-
GSK Investigational SiteIowa CityIowa52242-1009-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteBurlingtonMassachusetts01805-
GSK Investigational SiteMinneapolisMinnesota55404-
GSK Investigational SiteJacksonMississippi39216-
GSK Investigational SiteNew YorkNew York10022-
GSK Investigational SiteDurhamNorth Carolina27710-
GSK Investigational SiteClevelandOhio44106-
GSK Investigational SiteClevelandOhio44124-
GSK Investigational SiteEugeneOregon97401-
GSK Investigational SiteProvidenceRhode Island02905-
GSK Investigational SiteChattanoogaTennessee37403-
GSK Investigational SiteGermantownTennessee38138-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteFort WorthTexas76104-
GSK Investigational SiteSan AntonioTexas78229-
GSK Investigational SiteCharlottesvilleVirginia22903-

Find similar trials in Scottsdale, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Scottsdale, AZGSK Investigational Site· Duarte, CAGSK Investigational Site· Newport Beach, CAGSK Investigational Site· Orange, CAGSK Investigational Site· Solvang, CAGSK Investigational Site· Deerfield Beach, FL

Related Studies