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Peritoneal CancerPhase 2NCT02873962

A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib

A Phase 2 study testing Bevacizumab, Nivolumab and Rucaparib in people with Peritoneal Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bevacizumab, Nivolumab and Rucaparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
3 sitesUnited States
Study dates
10 Nov 2016to Jan 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Participants must have received a first-line platinum-based chemotherapy regimen
  • Participants must have relapsed disease despite standard therapy.
  • For Cohorts 1 and 2: Participants with platinum-resistant or platinum-sensitive disease (within 12 months) are eligible. Platinum-resistant disease is defined as relapse within 6 months after the last dose of platinum-based chemotherapy. Platinum-sensitive disease is defined as relapse greater than 6 months after the last dose of platinum-based chemotherapy. Participants with platinum-sensitive disease who have experienced relapse within 6 to 12 months after the last dose of platinum-based chemotherapy are eligible.Participants with primary platinum-refractory disease (defined as progression during or relapsed within 2 months of their initial platinum-based chemotherapy) are not eligible.
  • 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.
  • Participants must have received no more than 3 prior chemotherapy regimens. There is no limit to the number of prior hormonal therapies.
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  • Participants must have measurable disease by RECIST 1.1 criteria.
  • Participants who have received prior bevacizumab are eligible unless there is evidence of unacceptable toxicity due to prior bevacizumab exposure.
  • Participants may not have received any prior treatment with an anti-PD-1, anti PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
  • Participants must have stopped any hormonal therapy at least 1 week prior to treatment with nivolumab and bevacizumab.Participants may continue on hormone replacement therapy administered for post-menopausal symptoms.
  • Age ≥ 18 years
  • Estimated life expectancy of greater than 6 months.
  • ECOG performance status of 0 or 1
  • Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration:
  • WBC ≥ 2,000/µL
  • Neutrophils ≥ 1,500/µL
  • Platelets ≥ 100,000/mcL
  • Hemoglobin > 9.0 g/dL
  • Serum creatinine within the institutional ULN or creatinine clearance (CrCl) ≥ 60 mL/min (calculated using the Cockgroft-Gault formula) for participants with serum creatinine levels above institutional ULN
  • AST (SGOT) / ALT (SGPT) ≤ 3 × institutional ULN
  • Total bilirubin ≤ 1.5 × institutional ULN (except participants with Gilbert Syndrome, who can have total bilirubin ≤ 3.0 × institutional ULN with direct bilirubin that is within institutional ULN)
  • Coagulation parameters (INR, aPTT) ≤ 1.25 × institutional ULN
  • Patients with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible. Patients with stage IA endometrial cancer are eligible if the following conditions are met: without vascular or lymphatic invasion AND no serous, clear cell or grade 3 histology. Patients with early stage I or II cancers treated with curative intent who have no evidence of recurrent cancer 3 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible.
  • Participants must have biopsiable disease and be willing to undergo pre-treatment biopsy, or have an archival tumor sample obtained < 20 months prior to study entry.
  • Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. Additionally, women under the age of 62 who are not surgically sterile must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL to document postmenopausal status.
  • Nivolumab, bevacizumab, and rucaparib may each cause fetal harm or risk to human pregnancy. For this reason, WOCBP must agree to use appropriate method(s) of contraception for 6 months after the last dose of study treatment, per FDA recommendations on use of contraception following bevacizumab. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Patients receiving rucaparib should immediately discontinue rucaparib if they should become pregnant or suspect they are pregnant.
  • WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatments.
  • Women must not be breastfeeding
  • Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if > 10 mg/day prednisone equivalents, in the absence of active autoimmune disease. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • Ability to understand and the willingness to sign a written informed consent document.
  • 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.

Who cannot join

  • 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.
  • Patients with platinum-sensitive disease with relapse greater than 12 months after the last dose of platinum-based chemotherapy are ineligible.
  • Participants who have had chemotherapy or radiotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
  • Participants may not be receiving any other investigational agents nor have participated in an investigational trial within the past 4 weeks.
  • Participants must agree not to use natural herbal products or other "folk remedies" while participating in this study.
  • Patients with a history of allergic reactions attributed to bevacizumab or to compounds of similar chemical or biologic composition to nivolumab or bevacizumab are excluded.
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  • Patients are excluded if they have active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if metastases have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 6 months after treatment is complete and within 28 days prior to the first dose of nivolumab and bevacizumab administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
  • Patients with any of the following cardiovascular diseases are excluded:
  • History of myocardial infarction within six months
  • Unstable angina
  • Angina pectoris that requires the use of anti-anginal medication
  • History of documented congestive heart failure (NYHA classification of III or IV) or documented cardiomyopathy
  • Valvular disease with documented compromise in cardiac function
  • If cardiac function assessment is clinically indicated or performed:
  • LVEF less than normal per institutional guidelines, or < 55%, if threshold for normal not otherwise specified by institutional guidelines
  • Any prior history of hypertensive crisis or hypertensive encephalopathy
  • Patients may not have any evidence of pre-existing inadequately controlled hypertension (defined as a systolic BP of >140 mmHg or a diastolic BP of >90 mmHg), and must have a normal blood pressure (≤140/90 mmHg) taken in the clinic setting by a medical professional within 2 weeks prior to starting study.
  • Clinically significant peripheral vascular disease
  • Vascular disease including aortic aneurysm or dissection
  • History of stroke, transient ischemic attack or subarachnoid hemorrhage
  • Ventricular arrhythmias except for benign premature ventricular contractions
  • Cardiac conduction abnormality requiring a pacemaker
  • Known history of QT/QTc prolongation or torsades de pointes
  • QTc prolongation > 470 msec or other significant ECG abnormality noted during screening
  • Grade 2 or higher proteinuria (2+ or higher protein on urinalysis or urine protein:creatinine (UPC) ratio ≥ 1.0; if both tests are performed, UPC should be used to evaluate eligibility) or hematuria.
  • Participants may not have evidence of a bowel obstruction, abdominal fistula, or intra-abdominal abscess within 6 months of study entry. Participants with current signs or symptoms suggestive of bowel obstruction including early or partial obstruction are ineligible. Participants with a history of gastrointestinal perforation at any time point are ineligible.
  • Non-healing wound, ulcer or bone fracture.
  • Serious active infection requiring intravenous antibiotics and/or hospitalization at study entry.
  • Current dependency on IV hydration or TPN.
  • Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment may not participate in this study without discussion with and agreement of the study PI.
  • Uncontrolled current illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients are excluded if they have an active, known or suspected autoimmune disease other than the following: vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Patients are excluded if they have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration, with the exception of a brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen). Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption).
  • Patients are excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Patients are excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Evidence of prior or current coagulopathy or bleeding diathesis.
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to starting nivolumab and bevacizumab
  • History of severe infusion reactions to monoclonal antibody therapy
  • Specific criteria for Cohort 2 and 3
  • Patients who have received a prior PARP inhibitor are not allowed to enroll to Cohort 2 of the trial
  • Patients are excluded from Cohort 2 or Cohort 3 should they have pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Bevacizumab, Nivolumab, Rucaparib
Keywords
Relapsed Ovarian Cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    • Bevacizumab will be given intravenously at a pre-determined dosage
    • One dose reduction will be allowed for Bevacizumab

  • NivolumabDrug

    Also called Opdivo

    • 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

  • RucaparibDrug

    Also called Rubraca

    • 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).
Study groups in NCT02873962
Study groupRoleWhat they receive
Cohort 1: Nivolumab with BevacizumabExperimentalPatients will receive treatment every 14 days with Nivolumab and Bevacizumab administered on day 1 of each cycle.
Receives: Drug: Bevacizumab; Drug: Nivolumab
Cohort 2: Nivolumab with Bevacizumab and RucaparibExperimentalPatients 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 .
Receives: Drug: Bevacizumab; Drug: Nivolumab; Drug: Rucaparib
Cohort 3: Nivolumab with Bevacizumab and RucaparibExperimentalPatients 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 .
Receives: Drug: Bevacizumab; Drug: Nivolumab; Drug: Rucaparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: Objective Response Rate

    The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR. The ORR is therefore reported as the percentage of participants who achieved a CR or PR per RECIST v1.1.

    Measured: 18 months

  2. Cohort 2: Objective Response Rate

    The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR. The ORR is therefore reported as the percentage of participants who achieved a CR or PR per RECIST v1.1.

    Measured: 2 years

  3. Cohort 3: Tolerability

    Tolerability of the combination of nivolumab, bevacizumab, and rucaparib for cohort 3 was determined by the number of patients who maintained dosing without drug modifications (including dose holds and reductions) within the first 100 days of dosing.

    Measured: 100 days

Secondary outcomes (4)

  1. Progression Free Survival

    The percentage of patients progression-free at 6 months

    Measured: 6 months

  2. Best Overall Response Rate

    Using RESIST 1.1 criteria or modified GCIG CA-125 criteria

    Measured: 2 years

  3. Duration Of Response

    It will be described using the method of Kaplan-Meier

    Measured: 2 years

  4. The Association Of Baseline PD-L1 Expression With Anti-Tumor Activity

    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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2016 (estimated)
  2. Study start10 Nov 2016
  3. Primary completionFeb 2025
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02873962
Sponsor's protocol ID
16-263
Status last verified
Mar 2026
First submitted
17 Aug 2016
Last updated
1 Apr 2026
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Nivolumab and Rucaparib in people with Peritoneal Cancer and Ovarian Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Objective Response Rate (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02873962.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.

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