Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer

Conditions

• FIGO Stage III Ovarian Cancer 2014
• FIGO Stage IV Ovarian Cancer 2014
• Fallopian Tube Endometrioid Adenocarcinoma
• Fallopian Tube High Grade Serous Adenocarcinoma
• Ovarian Carcinoma
• Ovarian High Grade Endometrioid Adenocarcinoma
• Ovarian High Grade Serous Adenocarcinoma
• Primary Peritoneal Endometrioid Adenocarcinoma
• Primary Peritoneal High Grade Serous Adenocarcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Computed Tomography — PROCEDURE
  Undergo CT
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Olaparib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Mar 12, 2025

Status verified

Mar 2026

Primary completion

Dec 31, 2034

Completion

Dec 31, 2034

Study Design

Enrollment

880 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm I (olaparib, bevacizumab)
  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.
• Experimental: Arm II (olaparib, bevacizumab)
  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.

Primary Outcome Measure

Progression free survival (PFS) at least 360 days after randomization (PFS360) [ Time Frame: From completing 360 days of maintenance therapy to disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] version [v]1.1) or death, whichever occurs first, assessed up to 5 years ]

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