A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02873962|
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Cancer Ovarian Cancer Fallopian Tube Cancer||Drug: Bevacizumab Drug: Nivolumab Drug: Rucaparib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||November 10, 2016|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||February 2024|
Experimental: Nivolumab with Bevacizumab
Patients will receive treatment every 14 days with Nivolumab and Bevacizumab administered on day 1 of each cycle.
Other Name: Avastin
Other Name: Opdivo
Experimental: Nivolumab with Bevacizumab and Rucaparib
Patients will receive treatment every 14 days with Nivolumab, Bevacizumab administered on day 1 of each cycle and Rucaparib will be taken orally twice daily on days 1-14 .
Other Name: Avastin
Other Name: Opdivo
Other Name: Rubraca
- Cohort 1: Objective Response Rate [ Time Frame: 2 years ]Using RESIST 1.1 criteria or modified GCIG CA-125 criteria
- Cohort 2: Objective Response Rate [ Time Frame: 2 years ]Using RESIST 1.1 criteria or modified GCIG CA-125 criteria
- Progression Free Survival [ Time Frame: 6 months ]The percentage of patients progression-free at 6 months
- Best Overall Response Rate [ Time Frame: 2 years ]Using RESIST 1.1 criteria or modified GCIG CA-125 criteria
- Duration Of Response [ Time Frame: 2 years ]It will be described using the method of Kaplan-Meier
- The Association Of Baseline PD-L1 Expression With Anti-Tumor Activity [ Time Frame: 2 years ]It will be evaluated using a Wilcoxon rank sum test of marker levels in responders versus non-responders using a one-sided alpha = 0.05.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02873962
|Contact: Christin Whalen, RNfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Richard Penson, MD 617-742-4800|
|Principal Investigator: Richard Penson, MD|
|Dana Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Joyce Liu, MD MPH 617-632-5269 email@example.com|
|Principal Investigator: Joyce Liu, MD MPH|
|Beth Israel Deaconess Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Meghan Shea, MD 617-667-2100 firstname.lastname@example.org|
|Principal Investigator: Meghan Shea, MD|
|Principal Investigator:||Joyce Liu, MD MPH||Dana-Farber Cancer Institute|