A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib

NCT02873962 | Active Not Recruiting Phase 2 Results DMC

• 1 other identifier: 16-263
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

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.

Conditions

Peritoneal Cancer; Ovarian Cancer; Fallopian Tube Cancer

Keywords

Relapsed Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  18 months

• 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.

  2 years

• 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.

  100 days

Secondary Outcomes (4)

• Progression Free Survival

  6 months

• Best Overall Response Rate

  2 years

• Duration Of Response

  2 years

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

  2 years

Study Arms (3)

Cohort 1: Nivolumab with Bevacizumab

EXPERIMENTAL

Patients will receive treatment every 14 days with Nivolumab and Bevacizumab administered on day 1 of each cycle.

Drug: Bevacizumab; Drug: Nivolumab

Cohort 2: Nivolumab with Bevacizumab and Rucaparib

EXPERIMENTAL

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 .

Drug: Bevacizumab; Drug: Nivolumab; Drug: Rucaparib

Cohort 3: Nivolumab with Bevacizumab and Rucaparib

EXPERIMENTAL

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 .

Drug: Bevacizumab; Drug: Nivolumab; Drug: Rucaparib

Interventions

Bevacizumab DRUG

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

Also known as: Avastin

Cohort 1: Nivolumab with Bevacizumab; Cohort 2: Nivolumab with Bevacizumab and Rucaparib; Cohort 3: Nivolumab with Bevacizumab and Rucaparib

Nivolumab DRUG

* 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

Also known as: Opdivo

Cohort 1: Nivolumab with Bevacizumab; Cohort 2: Nivolumab with Bevacizumab and Rucaparib; Cohort 3: Nivolumab with Bevacizumab and Rucaparib

Rucaparib DRUG

* 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).

Also known as: Rubraca

Cohort 2: Nivolumab with Bevacizumab and Rucaparib; Cohort 3: Nivolumab with Bevacizumab and Rucaparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Bristol-Myers Squibb: collaborator
• Clovis Oncology, Inc.: collaborator

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Bevacizumab; Nivolumab; rucaparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Joyce Liu, MD MPH
• Organization: Dana-Farber Cancer Institute

joyce_liu@dfci.harvard.edu

617-632-5269

Study Officials

• Joyce Liu, MD MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Joyce Liu, MD, MPH

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: November 10, 2016
• Primary Completion: February 1, 2025
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026
• Results First Posted: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)