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NCT03602859 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Ovarian Neoplasms and Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma, sponsored by Tesaro.

Active
Registry status
Phase 3
Development phase
1,400
Enrollment target
20
Study locations

NCT03602859 is a Phase 3 study of Ovarian Neoplasms and Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma that is active but no longer recruiting, run by Tesaro. The registered enrollment target is 1,400 participants, above the 331-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (323% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT03602859, a Phase 3 study of Ovarian Neoplasms and Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma, is active but no longer recruiting, sponsored by Tesaro.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,400 participants
Enrollment target
20
Study locations

Study 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 in participants 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.

Conditions Studied

Ovarian Neoplasms Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

Interventions

  • DRUG Niraparib
  • DRUG Standard of care
  • DRUG Dostarlimab (TSR-042)
  • DRUG Dostarlimab-Placebo
  • DRUG Niraparib-Placebo

Study Locations (20)

California

  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Los Angeles
  • GSK Investigational Site - Newport Beach

Illinois

  • GSK Investigational Site - Geneva
  • GSK Investigational Site - Warrenville
  • GSK Investigational Site - Zion

Louisiana

  • GSK Investigational Site - Covington
  • GSK Investigational Site - New Orleans
  • GSK Investigational Site - Shreveport

Arizona

  • GSK Investigational Site - Phoenix
  • GSK Investigational Site - Tucson

Connecticut

  • GSK Investigational Site - Farmington
  • GSK Investigational Site - Hartford

Florida

  • GSK Investigational Site - Gainesville
  • GSK Investigational Site - Jacksonville

Maryland

  • GSK Investigational Site - Baltimore
  • GSK Investigational Site - Silver Spring

Alaska

  • GSK Investigational Site - Anchorage

Trial Details

FieldValue
Enrollment Target 1,400 participants
Start Date 2018-10-11
Est. Completion 2029-04-30
Phase Phase 3

Sponsor

Tesaro

26 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03602859

The ClinicalTrials.gov registry entry for NCT03602859 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 331-participant average among 38 other Ovarian Neoplasms trials with a reported enrollment target (323% higher). The listed sponsor is Tesaro, which has 26 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Ovarian Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Niraparib is the first listed.

NCT03602859 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Louisiana.

Frequently Asked Questions

What is clinical trial NCT03602859 about?

NCT03602859 is a clinical study titled "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". 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 sever...

What is the current status of trial NCT03602859?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2018-10-11. Estimated completion is 2029-04-30.

What conditions does trial NCT03602859 study?

This clinical trial studies the following conditions: Ovarian Neoplasms, Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma.

What interventions are being tested in trial NCT03602859?

The interventions under investigation include: Niraparib (DRUG), Standard of care (DRUG), Dostarlimab (TSR-042) (DRUG), Dostarlimab-Placebo (DRUG), Niraparib-Placebo (DRUG).

Who is sponsoring clinical trial NCT03602859?

This trial is sponsored by Tesaro, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03602859 being conducted?

This trial has 20 study locations across Alaska, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.