Olaparib +/- Bevacizumab for Ovarian Cancer

Recruiting at 509 trial locations

Overseen By Ying Liu, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: NRG Oncology

Must be taking: Platinum-based chemotherapy

Must not be taking: PARP inhibitors

Disqualifiers: Pregnancy, Cardiac disease, Infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 24

Duration: 1-2 years

880 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.

Research Team

Ying Liu

Principal Investigator

NRG Oncology

Eligibility Criteria

This trial is for patients with advanced ovarian cancer (stages III or IV) that's BRCA 1/2 mutated or homologous recombination deficient. Participants must have completed 4-9 cycles of platinum-based chemotherapy and undergone surgery to remove the tumor. They can't join if they've had certain treatments that could interfere with the study.

Inclusion Criteria

My cancer is high grade serous.

My cancer is high grade endometrioid or ovarian with a harmful BRCA mutation.

I have a BRCA1 or BRCA2 gene mutation linked to cancer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive olaparib for 1 or 2 years, with optional bevacizumab for up to 1 year

1-2 years

Every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Every 3 months for 2 years, then every 6 months for 3 years

Treatment Details

Interventions

• Bevacizumab
• Olaparib

Trial Overview The trial is testing how long to give Olaparib, a drug that blocks enzymes tumors need to grow, either one year or two years, and whether adding Bevacizumab, which stops blood vessel growth in tumors, makes a difference in treatment effectiveness.

Participant Groups

Group I: Arm II (olaparib, bevacizumab) Experimental Treatment 5 Interventions

Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study.

Group II: Arm I (olaparib, bevacizumab) Active Control 5 Interventions

Patients receive olaparib PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients may also receive bevacizumab IV on day 1 of each cycle. Cycles of bevacizumab repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT and/or MRI throughout the study.

Who Is Running the Clinical Trial?

NRG Oncology

Lead Sponsor

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+