Actively Recruiting
APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion
Led by Roswell Park Cancer Institute · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.
CONDITIONS
Official Title
APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer of specified histologies
- Symptomatic ascites or pleural effusion requiring at least one drainage within 4 weeks prior to study entry or having a drainage catheter
- ECOG performance status of 0 or 1
- No pembrolizumab or other immune checkpoint inhibitor treatment within 9 weeks prior to enrollment
- Life expectancy of at least 3 months
- Absolute neutrophil count of 1,500/µL or higher
- Platelets of 75,000/µL or higher
- Hemoglobin level of 9 g/dL or higher within 7 days prior to assessment
- Creatinine level up to 1.5 times upper normal limit or creatinine clearance of 60 mL/min or higher
- Total bilirubin up to 1.5 times upper normal limit or direct bilirubin within normal limits
- AST and ALT up to 2.5 times upper normal limit or up to 5 times if liver metastases present
- Albumin level above 2.5 gm/dL
- INR or PT up to 1.5 unless on anticoagulant therapy with therapeutic levels
- aPTT up to 1.5 times upper normal limit unless on anticoagulant therapy with therapeutic levels
- Negative pregnancy test within 72 hours prior to first study medication dose for women of childbearing potential
- Use of two birth control methods, surgical sterilization, or abstinence from heterosexual activity during study and 120 days after last dose for women of childbearing potential
- Willingness and ability to self-administer APL-2 (caregiver administration allowed)
- No known absolute contraindications to bevacizumab or pembrolizumab
- Willingness to receive specific vaccinations if randomized to APL-2 arms
- Ability to understand the investigational nature and provide informed consent
You will not qualify if you...
- Receiving any other cancer therapy or investigational drug/device within 3 weeks prior to first study dose
- Diagnosis of immunodeficiency or receiving systemic steroids or immunosuppressive therapy within 7 days prior to first dose
- Active autoimmune disease requiring systemic treatment in past 3 months (replacement therapies excluded)
- Active infection requiring systemic therapy
- Any condition or lab abnormality that may interfere with study participation or outcomes
- Clinically significant cardiovascular disease including uncontrolled hypertension, recent myocardial infarction or unstable angina, heart failure NYHA grade II or higher, peripheral vascular disease NYHA grade II or higher, or significant peripheral artery disease within 6 months
- Pregnancy or breastfeeding
- Unwillingness or inability to follow protocol requirements
- Any condition deemed unsuitable for study drug by investigator
- History or current pneumonitis/interstitial lung disease requiring steroids
- Known HIV infection
- Active hepatitis B or C infection
- Receipt of investigational vaccines not licensed or approved for emergency use
- Known additional malignancy progressing or requiring treatment within past 2 years except certain skin and in situ carcinomas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here