880 Participants Needed

Olaparib +/- Bevacizumab for Ovarian Cancer

Recruiting at 509 trial locations
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Overseen ByYing Liu, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: NRG Oncology
Must be taking: Platinum-based chemotherapy
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

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Ying Liu

Principal Investigator

NRG Oncology

Are You a Good Fit for This Trial?

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.
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Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (olaparib, bevacizumab)Experimental Treatment5 Interventions
Group II: Arm I (olaparib, bevacizumab)Active Control5 Interventions

Find a Clinic Near You

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+
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