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

PHASE2CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

November 15, 2018

Primary Completion Date

June 28, 2024

Study Completion Date

March 31, 2025

Conditions
Ovarian Neoplasms
Interventions
DRUG

Niraparib

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.

BIOLOGICAL

TSR-042

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).

BIOLOGICAL

Bevacizumab

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.

DRUG

Carboplatin

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

DRUG

Paclitaxel

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

Trial Locations (28)

10029

GSK Investigational Site, New York

14642

GSK Investigational Site, Rochester

15006

GSK Investigational Site, A Coruña

27710

GSK Investigational Site, Baltimore

28027

GSK Investigational Site, Madrid

28033

GSK Investigational Site, Madrid

28050

GSK Investigational Site, Madrid

29011

GSK Investigational Site, Málaga

31008

GSK Investigational Site, Pamplona

33606

GSK Investigational Site, Tampa

35249

GSK Investigational Site, Birmingham

55905

GSK Investigational Site, Rochester

57105

GSK Investigational Site, Sioux Falls

60637

GSK Investigational Site, Chicago

63141

GSK Investigational Site, St Louis

73104

GSK Investigational Site, Oklahoma City

77030

GSK Investigational Site, Houston

90095

GSK Investigational Site, Los Angeles

93003

GSK Investigational Site, Ventura

94109

GSK Investigational Site, San Francisco

94304

GSK Investigational Site, Stanford

98104

GSK Investigational Site, Seattle

04074

GSK Investigational Site, Scarborough

02114

GSK Investigational Site, Boston

02215

GSK Investigational Site, Boston

K1H 8L6

GSK Investigational Site, Ottawa

H2X 3E4

GSK Investigational Site, Montreal

H4A 3J1

GSK Investigational Site, Montreal

All Listed Sponsors
lead

Tesaro, Inc.

INDUSTRY

NCT03574779 - A Study to Evaluate the Efficacy and Safety of Novel Treatment Combinations in Participants With Ovarian Cancer | Biotech Hunter | Biotech Hunter