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Monoclonal Antibodies
Nivolumab + Bevacizumab + Rucaparib for Ovarian Cancer
Phase 2
Waitlist Available
Led By Joyce Liu, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants must have received a first-line platinum-based chemotherapy regimen
Participants must have histologic or cytologic confirmation of epithelial ovarian cancer, fallopian tube or peritoneal cancer. All histologies (including serous, mucinous, endometrioid, clear cell, MMMTs, and mixed histologies) are eligible. All tumor grades are eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing if Nivolumab, Bevacizumab, and Rucaparib can help treat relapsed ovarian, fallopian tube, or peritoneal cancer.
Who is the study for?
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.Check my eligibility
What is being tested?
The study tests a combination of Nivolumab (an immune system booster), Bevacizumab (a blood vessel growth inhibitor), and Rucaparib (a DNA repair blocker) in patients with specific types of relapsed cancers. It aims to evaluate the safety and effectiveness of this drug trio.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the drugs; bleeding issues; high blood pressure; bowel obstruction risks; wound healing complications; infusion reactions similar to monoclonal antibodies; increased risk of infections due to immunosuppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received first-line platinum-based chemotherapy.
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I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.
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I have taken bevacizumab before without severe side effects.
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I am 18 years old or older.
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I have not had treatments targeting specific immune system pathways.
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I am fully active or can carry out light work.
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My condition worsened despite receiving standard treatment.
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I have had 3 or fewer chemotherapy treatments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cohort 1: Objective Response Rate
Cohort 2: Objective Response Rate
Cohort 3: Safety and Tolerability
Secondary outcome measures
Best Overall Response Rate
Duration Of Response
Progression Free Survival
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Nivolumab with Bevacizumab and RucaparibExperimental Treatment3 Interventions
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 .
Group II: Cohort 2: Nivolumab with Bevacizumab and RucaparibExperimental Treatment3 Interventions
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 .
Group III: Cohort 1: Nivolumab with BevacizumabExperimental Treatment2 Interventions
Patients will receive treatment every 14 days with Nivolumab and Bevacizumab administered on day 1 of each cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rucaparib
2016
Completed Phase 3
~1990
Bevacizumab
2013
Completed Phase 4
~5280
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,598 Total Patients Enrolled
7 Trials studying Ovarian Cancer
1,789 Patients Enrolled for Ovarian Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,799 Total Patients Enrolled
39 Trials studying Ovarian Cancer
4,457 Patients Enrolled for Ovarian Cancer
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,441 Total Patients Enrolled
11 Trials studying Ovarian Cancer
1,144 Patients Enrolled for Ovarian Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery or a serious injury in the last 28 days.I have never taken PARP inhibitors before.My cancer returned more than 6 months after platinum chemotherapy, or within 6-12 months but not within 2 months.I rely on IV fluids or tube feeding for nutrition.I do not have a duodenal stent or any GI disorder that affects medication absorption.My cancer returned more than 12 months after my last platinum-based treatment.I haven't had chemotherapy or radiotherapy in the last 3 weeks and have recovered from any side effects.I am using certain approved corticosteroids.I have been tested for BRCA mutations and do not have harmful changes.I have received first-line platinum-based chemotherapy.My cancer did not worsen within 2 months after my last platinum-based treatment.My cancer returned 6-12 months after my last platinum-based treatment.I do not have any cardiovascular diseases.I have been diagnosed with ovarian, fallopian tube, or peritoneal cancer.I have taken bevacizumab before without severe side effects.I stopped my hormonal therapy at least a week ago but may continue hormone replacement for post-menopausal symptoms.I do not have any ongoing illnesses that would stop me from following the study's requirements.I haven't taken steroids or immunosuppressants in the last 14 days.I do not have HIV or AIDS.I have a history of bleeding disorders.I am 18 years old or older.I had early-stage skin, breast, or cervical cancer and received treatment.I can and agree to have a biopsy, or I have a recent tumor sample.I agree to use birth control for 6 months after my last treatment dose.I do not have active cancer spread to my brain or its coverings.I agree not to use herbal products or folk remedies during the study.I do not have an active autoimmune disease, except for allowed conditions.You must have a measurable disease based on specific medical guidelines.I do not have hepatitis B or C.I have not had treatments targeting specific immune system pathways.You have had serious allergic reactions to monoclonal antibody treatment in the past.Your doctor thinks you will live for at least 6 more months.My blood pressure is normal and controlled, checked by a doctor within the last 2 weeks.I have no allergies to bevacizumab or similar medications.I haven't had a bowel blockage, abdominal connection, or abscess in the last 6 months.I have a wound, ulcer, or bone fracture that hasn't healed.I do not have a serious infection requiring IV antibiotics or hospitalization.I am fully active or can carry out light work.My condition worsened despite receiving standard treatment.I have had 3 or fewer chemotherapy treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3: Nivolumab with Bevacizumab and Rucaparib
- Group 2: Cohort 1: Nivolumab with Bevacizumab
- Group 3: Cohort 2: Nivolumab with Bevacizumab and Rucaparib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Bevacizumab safe for human use?
"There is some data supporting Bevacizumab's safety, but none yet for efficacy. Our team scores it a 2."
Answered by AI
For what medical reasons is Bevacizumab typically prescribed?
"Bevacizumab is a medication used to treat melanoma, squamous cell carcinoma, and nonsquamous non-small cell lung cancer. It can also be given to patients with a high risk of recurrence."
Answered by AI
Could you please give a brief overview of the research Bevacizumab has undergone?
"At this moment in time, there are 1131 ongoing clinical trials evaluating the efficacy of Bevacizumab. 183 of these investigations are classified as Phase 3 trials. Most of the research is being conducted in Taibei, Taiwan; however, clinical trials for Bevacizumab can be found at 60430 locations worldwide."
Answered by AI
Are people still able to sign up for this experiment?
"From what is indicated on clinicaltrials.gov, it seems as though this trial is still recruiting patients. The first posting was on November 10th, 2016 with the most recent edit being on May 17th, 2022."
Answered by AI
How many people are enrolled in this clinical research project?
"That is correct, the online information hosted on clinicaltrials.gov affirms that this experiment is still recruiting patients. The trial was initially posted on November 10th, 2016 but has since been updated on May 17th, 2022. In total, the study needs 76 individuals at 3 separate locations."
Answered by AI
What are researchers hoping to study with this clinical trial?
"The aim of this trial, which will be assessed over the course of 2 years, is to evaluate Cohort 3 for safety and tolerability. Secondary outcomes include assessing the association of baseline PD-L1 expression with anti-tumor activity (using a Wilcoxon rank sum test), determining the best overall response rate (using RESIST 1.1 criteria or modified GCIG CA-125 criteria), and measuring progression free survival (defined as the percentage of patients who are progression-free at 6 months)."
Answered by AI
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