Phase 2
N=40
Pembrolizumab, Bevacizumab, and Cyclophosphamide in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Fallopian Tube Clear Cell Adenocarcinoma · Fallopian Tube Endometrioid Adenocarcinoma · Fallopian Tube Mucinous Adenocarcinoma · Fallopian Tube Serous Adenocarcinoma · Ovarian Clear Cell Adenocarcinoma
Bottom Line
View on ClinicalTrials.gov: NCT02853318 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events — 1; 9; 20; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bevacizumab (Biological); Cyclophosphamide (Drug); Laboratory Biomarker Analysis (Other); Pembrolizumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Roswell Park Cancer Institute
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events |
1; 9; 20; 9; 1; 0 | — |
| PRIMARY Progression-free Survival (PFS) |
10.0 | — |
| SECONDARY Duration of Overall Survival |
16.0 | — |
| SECONDARY An Anti-tumor Immune Response in Circulation and Tumor Tissue |
— | — |
| SECONDARY Objective Tumor Response Assessed by Modified RECIST Version 1.1 Criteria |
0.475 | — |
Summary
This phase II trial studies the combination of pembrolizumab, bevacizumab, and low dose oral cyclophosphamide in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Monoclonal antibodies, such as pembrolizumab and bevacizumab, may block tumor growth in different ways such as boosting your own immune system to find, recognize and kill tumor cells as well as by blocking the growth of new blood vessels necessary for tumor growth and nutrition. Drugs used in chemotherapy, such as low dose oral cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells, as well as by further enhancing your own body's immune response against cancer cells. As these three drugs have all been shown to improve the immune response against cancer cells giving pembrolizumab, bevacizumab, and cyclophosphamide together may work better in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer.
Eligibility Criteria
Inclusion Criteria
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have measurable disease per RECIST 1.1 criteria present
- Participant may have serous, endometrioid, clear cell, mucinous or undifferentiated type of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Histologic confirmation of the original primary tumor is required via the pathology report
- Participant can be either platinum-sensitive (platinum free interval [PFI] >= 6 months prior to recent recurrence) or platinum-resistant (PFI = 1,500 /mcL
- Platelets: >= 100,000 / mcL
- Hemoglobin: >= 9 g/dL or 5.6 mmol/L without transfusion or erythropoietin (EPO) dependency (within 7 days of assessment)
- Serum creatinine: = = 60 mL/min for participant with creatinine levels > 1.5 X institutional ULN; glomerular filtration rate (GFR) can also be used in place of creatinine or creatinine clearance (CrCl)
- Urine protein creatine ratio (UPCR) 1.5 ULN
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase[SGOT]) and alanine transaminase (ALT) (serum glutamic pyruvic transaminase [SGPT]): = 2.5 mg/dL
- International normalized ratio (INR) or prothrombin time (PT): = 1 year); should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately
- Participant has recovered from toxicities of prior chemotherapy or other therapy (to grade 2 or less)
- Participant may have received prior investigational therapy (including immune therapy)
- Participant may have received prior hormonal therapy
- Participant may have received bevacizumab (or other antiangiogenic agent) and/or cyclophosphamide in the past
- Participant has had at least 4 weeks of postoperative recovery from surgery prior to enrollment to ensure complete wound healing; participants with bowel resections at surgery should begin protocol at least 42 days after surgery
- Ability to swallow and retain oral medication
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or, is taking any other medication that might affect immune function
- Has a known history of active bacillus tuberculosis (TB)
- Hypersensitivity to bevacizumab, cyclophosphamide, pembrolizumab or any of its excipients
- Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or who has not recovered (i.e., = 150 mmHg or diastolic > 90 mmHg
- Myocardial infarction or unstable angina within 6 months prior to enrollment
- New York Heart Association (NYHA) grade II or greater congestive heart failure
- Participant has a grade II or greater peripheral vascular disease
- Participant has a clinically significant peripheral artery disease (e.g. those with claudication, within 6 months)
- Participant has organ allografts
- Participant is receiving medication(s) that might affect immune function
- Unwilling or unable to follow protocol requirements
Data sourced from ClinicalTrials.gov (NCT02853318). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.