Nivolumab + Bevacizumab + Rucaparib for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests three drugs for patients with relapsed ovarian, fallopian tube, or peritoneal cancer. Nivolumab helps the immune system fight cancer, Bevacizumab stops blood vessel growth, and Rucaparib blocks DNA repair in cancer cells. The goal is to find new treatment options for these patients. Bevacizumab has been approved for the treatment of advanced ovarian cancer and has shown effectiveness in prolonging survival in various studies.
Will I have to stop taking my current medications?
The trial requires participants to stop any hormonal therapy at least 1 week before starting treatment with nivolumab and bevacizumab, but hormone replacement therapy for post-menopausal symptoms can continue. Participants must also avoid natural herbal products or 'folk remedies' during the study.
Is the combination of Nivolumab, Bevacizumab, and Rucaparib generally safe for humans?
Bevacizumab, one of the drugs in the combination, has been approved for use in ovarian cancer and has been studied in several clinical trials, showing expected types and frequencies of side effects. Rucaparib is also approved for ovarian cancer, but specific safety data for the combination with Nivolumab is not detailed in the available research.12345
How does the drug combination of Nivolumab, Bevacizumab, and Rucaparib for ovarian cancer differ from other treatments?
This drug combination is unique because it combines Nivolumab, an immune checkpoint inhibitor that helps the immune system attack cancer cells, with Bevacizumab, which inhibits blood vessel growth in tumors, and Rucaparib, a PARP inhibitor that targets cancer cell DNA repair mechanisms. This multi-faceted approach is different from standard treatments that typically focus on chemotherapy or single-agent therapies.678910
What data supports the effectiveness of the drug combination Nivolumab, Bevacizumab, and Rucaparib for ovarian cancer?
Research shows that Bevacizumab, when combined with standard chemotherapy, improves progression-free survival in ovarian cancer patients, especially those at high risk of disease progression. Additionally, combining immunotherapy with anti-angiogenesis agents like Bevacizumab has shown improved outcomes in various cancers, suggesting potential benefits for ovarian cancer.910111213
Who Is on the Research Team?
Joyce Liu, MD
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
This trial is for adults over 18 with relapsed ovarian, fallopian tube, or peritoneal cancer who've had standard therapy and up to 3 chemo regimens. They must not be pregnant, breastfeeding, have certain allergies or infections, uncontrolled illnesses, recent surgeries or severe psychiatric conditions. Participants need measurable disease by RECIST criteria and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Nivolumab, Bevacizumab, and Rucaparib every 14 days, with Rucaparib taken orally twice daily on days 1-14
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Nivolumab
- Rucaparib
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Clovis Oncology, Inc.
Industry Sponsor
Patrick J. Mahaffy
Clovis Oncology, Inc.
Chief Executive Officer since 2009
BA from Haverford College, MBA from Columbia University
Lindsey Rolfe
Clovis Oncology, Inc.
Chief Medical Officer since 2015
Specialist accreditation in pharmaceutical medicine
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania