NCT02873962

A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib

A Phase II Study With a Safety lead-in of Nivolumab in Combination With Bevacizumab or in Combination With Bevacizumab and Rucaparib for the Treatment of Relapsed Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is evaluating three drugs called Nivolumab, Bevacizumab, and Rucaparib as a possible treatment for relapsed Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer.

Detailed description

This research study is a Phase II clinical trial. Cancers are recognized by the immune system, and under some circumstances,the immune system may control or even eliminate tumors. An antibody is a natural protein made by our immune system that binds other proteins and molecules to fight infection and its ill effects. Nivolumab is an experimental antibody drug that may make the immune response more active against Cancer. Bevacizumab is an antibody that works by stopping the formation of blood vessels.Rucaparib is an oral pill that can block the ways cells repair their DNA, which can cause damage to certain cancer cells. The FDA (the U.S. Food and Drug Administration) has not approved Nivolumab for Relapsed Ovarian, Fallopian Tube Or Peritoneal Cancer but it has been approved for other uses. Bevacizumab has been FDA approved when used together with chemotherapy for the treatment of Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer that has returned within 6 months of a chemotherapy that contains a platinum drug. Rucaparib has been FDA approved for the treatment of patients with BRCA-mutated ovarian cancer who have been treated with 2 or more prior chemotherapies or as maintenance therapy following for women with platinum-sensitive recurrent ovarian cancer. The combination of Nivolumab, Bevacizumab, and Rucaparib has not been approved by the FDA in any setting.

Conditions

• Peritoneal Cancer
• Ovarian Cancer
• Fallopian Tube Cancer

Interventions

Type	Name	Description
DRUG	Bevacizumab	* Bevacizumab will be given intravenously at a pre-determined dosage * One dose reduction will be allowed for Bevacizumab
DRUG	Nivolumab	* Nivolumab injection is to be administered as an IV infusion at a pre-determined dosage. * No dose reductions or escalations will be allowed for Nivolumab
DRUG	Rucaparib	* Rucaparib will be taken orally twice daily on days 1-14 at a pre-determined dosage. * Up to three dose reductions will be allowed for Rucaparib (depending on cohort).

Timeline

• Start date: 2016-11-10
• Primary completion: 2025-02-01
• Completion: 2027-01-01
• First posted: 2016-08-22
• Last updated: 2026-04-01
• Results posted: 2026-04-01

Locations

3 sites across 1 country: United States