Combination Therapy for Ovarian Cancer
(OPAL Trial)
Trial Summary
What is the purpose of this trial?
This trial tests niraparib alone and with other treatments in patients with ovarian, fallopian tube, or primary peritoneal cancer. It aims to see if stopping cancer cells from repairing their DNA can help treat these cancers. Niraparib is a medication taken by mouth and is approved for use in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who have responded to previous treatments.
Research Team
GSK Clinical Trials
Principal Investigator
GlaxoSmithKline
Eligibility Criteria
This trial is for women aged 18 or older with high-grade recurrent ovarian, fallopian tube, or primary peritoneal cancer. They must have measurable disease and be in good enough health to participate (ECOG status of 0-2). Pregnant or breastfeeding women can't join, and participants need adequate organ function and not be on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-Screening
Participants receive a run-in cycle of carboplatin-paclitaxel to confirm HRd status
Treatment
Participants receive treatment with TSR-042, Bevacizumab, and Niraparib or platinum-taxane doublet chemotherapy
Maintenance
Participants receive maintenance treatment with Niraparib and optional Bevacizumab
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bevacizumab
- Carboplatin
- Niraparib
- Paclitaxel
- TSR-042
Carboplatin is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Testicular cancer
- Lung cancer
- Head and neck cancer
- Brain cancer
- Ovarian cancer
- Small cell lung cancer
- Ovarian cancer
- Small cell lung cancer
- Testicular cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tesaro, Inc.
Lead Sponsor