Combination Therapy for Ovarian Cancer

(OPAL Trial)

Recruiting at 31 trial locations

Overseen By US GSK Clinical Trials Call Center

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Tesaro, Inc.

Must not be taking: Steroids, Immunosuppressants, Live vaccines

Disqualifiers: Immunodeficiency, Uncontrolled brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 15 months

77 Participants Needed

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

My white blood cell count is healthy without needing medication.

Participant is not pregnant or breastfeeding and meets the specified conditions

Additional requirements for pregnancy testing during and after study treatment as per protocol

Exclusion Criteria

Participants specific to Cohort C must meet additional exclusion criteria as specified

I had cancer treatment within the last 3 weeks.

I have uncontrolled cancer spread to my brain or its coverings causing symptoms.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Screening

Participants receive a run-in cycle of carboplatin-paclitaxel to confirm HRd status

Up to 5 weeks

Treatment

Participants receive treatment with TSR-042, Bevacizumab, and Niraparib or platinum-taxane doublet chemotherapy

Up to 15 months

Maintenance

Participants receive maintenance treatment with Niraparib and optional Bevacizumab

Until progression or toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 4 years

Treatment Details

Interventions

• Bevacizumab
• Carboplatin
• Niraparib
• Paclitaxel
• TSR-042

Trial Overview The study tests the effectiveness and safety of niraparib alone or combined with other treatments like TSR-042, Bevacizumab, Paclitaxel, Carboplatin in treating ovarian cancer. Cohort A focuses on those with recurrent cancer; Cohort C includes newly diagnosed patients.

Participant Groups

Group I: Cohort C: Arm 2: Participants receiving neoadjuvant Niraparib Experimental Treatment 2 Interventions

Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is HRd, participants will be randomized to three 21-day cycles of neoadjuvant niraparib therapy. After IDS, all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.

Group II: Cohort A: 1-2 prior lines of therapy (TSR-042, Bevacizumab, and Niraparib) Experimental Treatment 3 Interventions

PARP Inhibitor-Naive Platinum-Resistant Ovarian Cancer Treatment Cohort with TSR-042, Bevacizumab, and Niraparib. TSR-042 administered 500 milligrams (mg) on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning on Cycle 5 Day 1 until progressive disease (PD) or toxicity. Bevacizumab administered 15 milligram per kilogram (mg/kg) every 3 weeks for up to 15 months. Niraparib 200 or 300 mg per day until PD or toxicity.

Group III: Cohort C: Arm 1: Participants receiving platinum plus taxane Active Control 4 Interventions

Participants are expected to receive 1 run-in cycle (up to 5 weeks) of carboplatin-paclitaxel during pre-screening. After confirmation that the tumor is homologous recombination-deficient (HRd). Participants will then be randomized to three 21-day cycles of platinum-taxane doublet chemotherapy (carboplatin plus paclitaxane). After interval debulking surgery (IDS), all participants will receive up to three 21-day cycles of adjuvant platinum-taxane doublet chemotherapy (and optional bevacizumab for participants deemed high-risk; third cycle is optional) followed by niraparib (and optional bevacizumab or bevacizumab biosimilar for participants deemed high- risk) maintenance treatment.

Carboplatin is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Paraplatin for:

• Ovarian cancer
• Testicular cancer
• Lung cancer
• Head and neck cancer
• Brain cancer

Approved in European Union as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer

Approved in Canada as Carboplatin for:

• Ovarian cancer
• Small cell lung cancer
• Testicular cancer

Who Is Running the Clinical Trial?

Tesaro, Inc.

Lead Sponsor

Trials

57

Recruited

10,600+