Actively Recruiting
Randomized Phase 2 Trial of APL-2 with Pembrolizumab versus APL-2 with Pembrolizumab and Bevacizumab versus Bevacizumab Alone for Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer with Malignant Effusion
Led by Roswell Park Cancer Institute · Updated on 2026-03-23
60
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the effects of APL-2 combined with pembrolizumab, or with pembrolizumab and bevacizumab, compared to bevacizumab alone in patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer who have malignant effusion. This phase II trial aims to assess whether APL-2 can help limit tumor progression, reduce malignant fluid buildup, and enhance the immune response against cancer cells. Immunotherapy drugs like pembrolizumab and bevacizumab are being studied for their potential to help the immune system attack cancer and interfere with tumor growth and spread. Participants are randomly assigned to different treatment groups receiving combinations of pegcetacoplan (APL-2), pembrolizumab, and bevacizumab. Pegcetacoplan is given intravenously on the first day of the first cycle and then subcutaneously twice weekly during each cycle. Pembrolizumab and bevacizumab are administered intravenously on the first day of each cycle. Treatment cycles repeat every three weeks for up to seven cycles unless disease progression or unacceptable side effects occur. Pembrolizumab may be continued for up to 35 cycles. Tumor biopsies and blood samples are collected throughout the study to monitor immune and biological changes. Participants undergo regular assessments including the volume of malignant effusion drained every three weeks, quality of life questionnaires, and monitoring for adverse events. After completing treatment, follow-up visits occur at 30 days and then every 12 weeks to evaluate outcomes such as progression-free survival, overall survival, response rates, and quality of life. The study also includes exploratory analyses of immune system changes, tumor environment, and microbiome from collected samples. The total participation duration may extend up to three years for some outcome measurements.
CONDITIONS
Brief 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 informed consent
- Recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with specified histologies, regardless of platinum sensitivity, prior stage, or number of prior treatments
- Symptomatic ascites or pleural effusion requiring at least one drainage within 4 weeks or having a drainage catheter in place
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No pembrolizumab or immune checkpoint inhibitor treatment within 9 weeks prior to enrollment
- Life expectancy of at least 3 months
- Adequate blood counts: absolute neutrophil count ≥ 1,500/µL, platelets ≥ 75,000/µL, hemoglobin ≥ 9 g/dL
- Kidney function: creatinine ≤ 1.5 times upper limit normal or creatinine clearance ≥ 60 mL/min
- Liver function within specified limits
- Albumin > 2.5 gm/dL
- INR/PT ≤ 1.5 unless on anticoagulants with therapeutic levels
- Negative pregnancy test for women of childbearing potential
- Willingness to use effective birth control or abstain during study and 120 days after last dose
- Able to self-administer APL-2 or have caregiver assist
- No known contraindications to bevacizumab or pembrolizumab
- Willing to receive vaccines against specific bacteria if in APL-2 groups
- Signed informed consent
You will not qualify if you...
- Receiving other cancer therapies or investigational drugs/devices within 3 weeks before treatment
- Immunodeficiency or recent immunosuppressive therapy within 7 days before treatment
- Active autoimmune disease requiring recent systemic treatment
- Active infection requiring systemic therapy
- Conditions or lab abnormalities that could interfere with participation or study results
- Significant cardiovascular disease including uncontrolled hypertension, recent heart attack or unstable angina, heart failure NYHA Grade II or higher, significant peripheral vascular disease
- Pregnancy or breastfeeding
- Unwilling or unable to follow study protocol
- History of pneumonitis or interstitial lung disease requiring steroids or current lung disease
- Known HIV infection
- Active hepatitis B or C infection
- Use of investigational vaccines not approved for emergency use
- Other progressing malignancies requiring treatment within past 2 years, except certain skin cancers or carcinoma in situ treated with curative intent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years (up to 35 cycles of 21 days each)
Participants receive assigned study treatments including pegcetacoplan, pembrolizumab, and/or bevacizumab depending on their cohort. Treatment cycles repeat every 3 weeks for up to 7 cycles. Pembrolizumab may continue for up to 35 cycles in some cohorts. Participants undergo tumor biopsies and blood sample collections throughout treatment.
Treatment visits every 3 weeks; subcutaneous injections twice weekly during each cycle; tumor biopsies and blood collections throughout treatment
Duration - Up to 3 years after treatment
After completing study treatment, participants are followed for safety and disease status with visits at 30 days post-treatment and then every 12 weeks thereafter.
1 visit at 30 days post-treatment and then visits every 12 weeks
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
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