A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib
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ClinicalTrials.gov Identifier: NCT02873962 |
Recruitment Status :
Active, not recruiting
First Posted : August 22, 2016
Last Update Posted : May 7, 2024
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Tracking Information | ||||
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First Submitted Date ICMJE | August 17, 2016 | |||
First Posted Date ICMJE | August 22, 2016 | |||
Last Update Posted Date | May 7, 2024 | |||
Actual Study Start Date ICMJE | November 10, 2016 | |||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Objective Response Rate [ Time Frame: 2 years ] Using RESIST 1.1 criteria or modified GCIG CA-125 criteria
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib | |||
Official Title ICMJE | 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 | |||
Brief 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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Active, not recruiting | |||
Actual Enrollment ICMJE |
73 | |||
Original Estimated Enrollment ICMJE |
38 | |||
Estimated Study Completion Date ICMJE | July 2026 | |||
Estimated Primary Completion Date | July 2024 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
For Cohort 3: Participants must have platinum-sensitive disease and have experienced relapse within 6 to 12 months (i.e., 180 to 365 days) after the last dose of platinum-based chemotherapy.
Specific criteria for Cohort 2 and 3 -Patients must have undergone germline BRCA testing and must not have a deleterious or suspected deleterious BRCA mutation. Where tumor testing has been performed, patients with a deleterious or suspected deleterious somatic BRCA mutation are also not eligible. Exclusion Criteria:
LVEF less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
Specific criteria for Cohort 2 and 3
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02873962 | |||
Other Study ID Numbers ICMJE | 16-263 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | Joyce Liu, MD, Dana-Farber Cancer Institute | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | |||
Verification Date | May 2024 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |