A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer — FIRST

Ovarian Neoplasms Clinical Trial

Official title:
A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

Status Active, not recruiting

Clinical Trial Summary

Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated both in the PD-L1 positive and overall population of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03602859
Study type	Interventional
Source	Tesaro, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 3
Start date	October 11, 2018
Completion date	June 22, 2026

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03371693` - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer	Phase 3
Active, not recruiting	`NCT03648489` - Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)	Phase 2
Active, not recruiting	`NCT02950064` - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations	Phase 1
Completed	`NCT02569983` - The SOCQER-2 Study Surgery in Ovarian Cancer - Quality of Life Evaluation Research
Withdrawn	`NCT02243059` - Magnetic Resonance Imaging for Lymph Node Staging in Ovarian Cancer	Phase 4
Terminated	`NCT02055690` - PAZOFOS: Phase Ib and Phase II Trial of Pazopanib +/- Fosbretabulin in Advanced Recurrent Ovarian Cancer	Phase 1/Phase 2
Completed	`NCT01719926` - Phase I Platinum Based Chemotherapy Plus Indomethacin	Phase 1
Completed	`NCT00415181` - Pharmacogenomics of Paclitaxel in Ovarian Cancer	N/A
Completed	`NCT00243685` - Chemotherapy Drug Sensitivity Microculture (MiCK) Assay for Apoptosis	Phase 2/Phase 3
Recruiting	`NCT01789229` - Establishment of a Tumor Bank for Tissue Samples
Completed	`NCT00069160` - Tariquidar and Docetaxel to Treat Patients With Lung, Ovarian, Renal and Cervical Cancer	Phase 2
Completed	`NCT00772863` - Efficacy and Safety of Subsequent Cisplatin and Docetaxel in Ovarian Cancer	Phase 2
Completed	`NCT00046800` - Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer	Phase 2
Completed	`NCT00035100` - EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer	Phase 2
Terminated	`NCT00034372` - Multicenter Clinical Trial of Intravenous OvaRex MAb-B43.13 as Post-Chemotherapy Consolidation for Ovarian Carcinoma	Phase 2
Completed	`NCT00001272` - A Phase I Study of Taxol, Cisplatin, Cyclophosphamide and Granulocyte Colony-Stimulating Factor (G-CSF) in Previously Nontreated Ovarian Cancer Patients	Phase 1
Recruiting	`NCT05007106` - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)	Phase 2
Recruiting	`NCT05001282` - A Study to Evaluate ELU001 in Patients With Solid Tumors That Overexpress Folate Receptor Alpha (FRα)	Phase 1/Phase 2
Completed	`NCT02227654` - Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors	N/A
Not yet recruiting	`NCT04055038` - Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)	Phase 2/Phase 3