What side effects are associated with this type of intervention?

Nivolumab, a PD-1 inhibitor, commonly causes skin reactions, endocrine events, and immune-related adverse effects such as pneumonitis and colitis. Bevacizumab, a VEGF inhibitor, is associated with hypertension, bleeding, and gastrointestinal perforations. Rucaparib, a PARP inhibitor, often leads to nausea, fatigue, anemia, and elevated liver enzymes. These side effects are important considerations when evaluating treatment options for ovarian cancer.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of ovarian cancer that are similar to those being studied in the trial. Bevacizumab, a VEGF inhibitor, has been approved for use in combination with chemotherapy for advanced ovarian cancer, showing improvements in progression-free survival (PFS). Rucaparib, a PARP inhibitor, has been approved for the treatment of recurrent, platinum-sensitive ovarian cancer, both as maintenance therapy and monotherapy. While Nivolumab, a PD-1 inhibitor, is being studied in various cancers, its use in ovarian cancer is still under investigation. These approvals highlight the evolving landscape of targeted therapies in ovarian cancer treatment.

What other types of research exist?

Promising novel alternatives for ovarian cancer treatment in 2024 include: 1) Pembrolizumab (PD-1 inhibitor) combined with Lenvatinib (VEGF inhibitor), which has shown efficacy in other cancers and may be applicable to ovarian cancer. 2) Olaparib (PARP inhibitor) combined with immunotherapy agents like Nivolumab, which has shown potential in other BRCA-mutated cancers. 3) Combination of Durvalumab (PD-L1 inhibitor) with chemotherapy, which has shown promise in other solid tumors and may be explored for ovarian cancer.

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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.

Must not have

Current dependency on IV hydration or TPN.

Patients with platinum-refractory disease are ineligible. Platinum-refractory disease is defined as relapse less than 2 months after the last dose of platinum-based chemotherapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on IV fluids or tube feeding for nutrition.

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My cancer did not worsen within 2 months after my last platinum-based treatment.

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I do not have any cardiovascular diseases.

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I do not have any ongoing illnesses that would stop me from following the study's requirements.

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I haven't taken steroids or immunosuppressants in the last 14 days.

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I do not have HIV or AIDS.

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I have a history of bleeding disorders.

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I have never taken PARP inhibitors before.

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I do not have active cancer spread to my brain or its coverings.

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I agree not to use herbal products or folk remedies during the study.

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I do not have an active autoimmune disease, except for allowed conditions.

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I do not have hepatitis B or C.

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I have no allergies to bevacizumab or similar medications.

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I have a wound, ulcer, or bone fracture that hasn't healed.

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I do not have a serious infection requiring IV antibiotics or hospitalization.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cohort 1: Objective Response Rate

Cohort 2: Objective Response Rate

Cohort 3: Safety and Tolerability

Secondary study objectives

Best Overall Response Rate

Duration Of Response

Progression Free Survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~2020

Bevacizumab

2013

Completed Phase 4

~5540

Nivolumab

2015

Completed Phase 3

~4010

0 / 23Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Nivolumab, Bevacizumab, and Rucaparib are common treatments for ovarian cancer, each with a unique mechanism of action. Nivolumab, a PD-1 inhibitor, enhances the immune system's ability to detect and destroy cancer cells. Bevacizumab, a VEGF inhibitor, blocks the formation of new blood vessels that tumors need to grow. Rucaparib, a PARP inhibitor, targets cancer cells with defective DNA repair mechanisms, leading to their death. These targeted therapies are significant for ovarian cancer patients as they offer more effective and personalized treatment options, potentially improving survival rates and quality of life.

Aflibercept in epithelial ovarian carcinoma.