A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Tesaro, Inc.
Study ID
NCT03574779
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Niraparib — DRUG
    Niraparib is a potent, orally active PARP1 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.
  • TSR-042 — BIOLOGICAL
    TSR-042 is a humanized monoclonal antibody that binds with high affinity to Programmed cell death protein 1 (PD-1) resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
  • Bevacizumab — BIOLOGICAL
    Bevacizumab is an Food Drug and Administration (FDA) approved antiangiogenic recombinant humanized monoclonal Immunoglobulin (Ig) G1 antibody against the vascular endothelial growth factor protein, which has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma.
  • Carboplatin — DRUG
    Carboplatin will be infused intravenously over 60 minutes at the prescribed dose of area under the concentration versus time curve of 5 to 6 mg/milliliters (mL) per minute on Day 1 of every 21-day cycle
  • Paclitaxel — DRUG
    Paclitaxel will be administered intravenously over 180 minutes at the prescribed dose of 175 mg/meter square (m\^2) on Day 1 of every 21-day cycle

Study Details

This study will evaluate the efficacy and safety of niraparib and novel treatment combinations of niraparib as described within each cohort-specific supplement in participants with ovarian, fallopian tube, or primary peritoneal cancer. Cohort A (single arm) includes participants with recurrent ovarian cancer. Cohort B will not be initiated. Cohort C (randomized-2 arms) includes participants with newly diagnosed ovarian cancer.

Key Dates

Start date
Nov 15, 2018
Status verified
Jun 2025
Primary completion
Jun 28, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
77 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib)
    PARP Inhibitor-Naive Platinum-Resistant Ovarian Cancer Treatment Cohort with TSR-042, Bevacizumab, and Niraparib. TSR-042 administered 500 milligrams (mg) on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning on Cycle 5 Day 1 until progressive disease (PD) or toxicity. Bevacizumab administered 15 milligram per kilogram (mg/kg) every 3 weeks for up to 15 months. Niraparib 200 or 300 mg per day until PD or toxicity.
  • Active Comparator: Cohort C: Arm 1: Participants receiving platinum plus taxane
    Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is homologous recombination-deficient (HRd). Participants will then be randomized to three 21-day cycles of platinum-taxane doublet chemotherapy (carboplatin plus paclitaxane). After interval debulking surgery (IDS), all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.
  • Experimental: Cohort C: Arm 2: Participants receiving neoadjuvant Niraparib
    Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is HRd, participants will be randomized to three 21-day cycles of neoadjuvant niraparib therapy. After IDS, all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.

Primary Outcome Measure

Number of Participants Enrolled Across Cohorts [ Time Frame: Day 1 ]

Locations (19)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBirminghamAlabama35249-
GSK Investigational SiteLos AngelesCalifornia90095-
GSK Investigational SiteSan FranciscoCalifornia94109-
GSK Investigational SiteStanfordCalifornia94304-
GSK Investigational SiteVenturaCalifornia93003-
GSK Investigational SiteTampaFlorida33606-
GSK Investigational SiteChicagoIllinois60637-
GSK Investigational SiteScarboroughMaine04074-
GSK Investigational SiteBaltimoreMaryland27710-
GSK Investigational SiteBostonMassachusetts02114-
GSK Investigational SiteBostonMassachusetts02215-
GSK Investigational SiteRochesterMinnesota55905-
GSK Investigational SiteSt LouisMissouri63141-
GSK Investigational SiteNew YorkNew York10029-
GSK Investigational SiteRochesterNew York14642-
GSK Investigational SiteOklahoma CityOklahoma73104-
GSK Investigational SiteSioux FallsSouth Dakota57105-
GSK Investigational SiteHoustonTexas77030-
GSK Investigational SiteSeattleWashington98104-

Find similar trials in Birmingham, AL

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
GSK Investigational Site· Birmingham, ALGSK Investigational Site· Los Angeles, CAGSK Investigational Site· San Francisco, CAGSK Investigational Site· Stanford, CAGSK Investigational Site· Ventura, CAGSK Investigational Site· Tampa, FL

Related Studies