Trial on NIraparib-TSR-042 (Dostarlimab) vs Physician's Choice CHEmotherapy in Recurrent, Ovarian, Fallopian Tube or Primary Peritoneal Cancer Patients Not Candidate for Platinum Retreatment

NCT04679064 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 427

Last updated 2021-08-27

No results posted yet for this study

Summary

Randomized phase 3 trial evaluating niraparib plus dostarlimab vs chemotherapy at physician's choice in the treatment of recurrent ovarian, fallopian tube or primary peritoneal cancer patients for which platinum is not an option

Conditions

Interventions

DRUG

Niraparib

PARP-inihibitor

DRUG

Dostarlimab

PD-1 inihibitor

DRUG

Pegylated liposomal doxorubicin

Chemotherapy drug

DRUG

Paclitaxel

Chemotherapy drug

DRUG

Gemcitabine

Chemotherapy drug

DRUG

Topotecan

Chemotherapy drug

DRUG

Bevacizumab

Chemotherapy drug

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2025-01-01
Completion
2025-01-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04679064 on ClinicalTrials.gov