Study of APL-2, Pembrolizumab, and Bevacizumab for Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer
This study is for women aged 18 or older with recurrent ovarian, fallopian tube, or primary peritoneal cancer that has returned and caused a buildup of fluid and cancer cells (malignant effusion). It compares three treatment approaches: APL-2 (pegcetacoplan) with pembrolizumab, APL-2 with pembrolizumab and bevacizumab, or bevacizumab alone. Researchers want to see if APL-2 can help slow tumor growth, reduce fluid buildup, and improve the body's immune response against cancer. Pembrolizumab and bevacizumab are both monoclonal antibodies that may help the immune system fight cancer and stop cancer cells from growing and spreading. The study aims to understand the safety of these treatments and their effect on the accumulation of malignant effusion. This study is currently recruiting 60 participants, but its status is unclear.
- Study design
- This interventional study plans to enroll 60 participants. It is not specified if it is randomized or blinded.
- What's involved
- Participants will receive Bevacizumab, Pegcetacoplan, and/or Pembrolizumab intravenously (IV) or subcutaneously (SC). They will also undergo tumor biopsies and blood sample collection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Adverse events will be measured up to 30 days after the last dose. Accumulation of effusion will be measured for up to 3 years.
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NCT04919629
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentRoswell Park Cancer InstituteInvestigator-initiated
~60 participants
Updated 2026-03-23 on ClinicalTrials.gov
What's tested:BevacizumabBiopsyBiospecimen CollectionPegcetacoplanPembrolizumabQuestionnaire Administration
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (Phase 2a)
Measured over Up to 30 days after last dose
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Emese Zsiros · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Age \>= 18 years of age on day of signing informed consent
Recurrent epithelial ovarian/fallopian tube or primary peritoneal cancer (serous, clear cell, endometrioid, mixed or poorly differentiated or carcinosarcoma) based on imaging or synchronous primary ovarian and uterine cancer patients with any of the histology subtypes mentioned above regardless of platinum sensitivity, prior stage or number of prior treatment lines
Symptomatic ascites or pleural effusion or both requiring \>= 1 drainage within 4-weeks of study entry or has a peritoneal/pleural drainage catheter in place to control symptoms
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment
Life expectancy of \>= 3 months
Absolute neutrophil count (ANC): \>= 1,500/µL
Platelets: \>= 75,000/µL
Hemoglobin: \>= 9 g/dL or 5.6 mmol/L (within 7 days of assessment)
Creatinine: =\< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \>= 60 mL/min (Cockcroft-Gault Equation) for participant with creatinine levels \> 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl)
Total bilirubin: =\< 1.5 X ULN OR direct bilirubin =\< ULN for participants with total bilirubin levels \> 1.5 ULN
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 X ULN OR =\< 5 X ULN for participants with liver metastases
Albumin: \> 2.5 gm/dL
International Normalized Ratio (INR) or Prothrombin Time (PT): =\< 1.5 unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants
Activated Partial Thromboplastin Time (aPTT): =\< 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 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
Willing and able to self-administer APL-2 (administration by caregiver will be allowed)
No known absolute contraindication to bevacizumab and/or pembrolizumab treatment per enrolling provider
Willing to receive vaccination against Neisseria meningitidis, Streptococcus pneumoniae, and Hemophilus influenzae if randomized into an APL-2 receiving arm, if not already vaccinated
Participant 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
Is currently receiving any additional cancer therapy or participating or used an investigational drug or device within 3 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 active autoimmune disease that has required systemic treatment in the past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment
Has an active infection requiring systemic therapy
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator
Participant has clinically significant cardiovascular disease including:
Uncontrolled hypertension, defined as systolic \>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 (NYHA) or greater peripheral vascular disease
Participant has a clinically significant peripheral artery disease (e.g. those with claudication), within 6 months prior to study enrollment
Pregnancy or lactation
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has a known history of human immunodeficiency virus (HIV) infection
Concurrent active hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] positive and/or detectable HBV deoxyribonucleic acid \[DNA\]) and hepatitis C virus (HCV) (defined as anti-HCV Ab positive and detectable HCV ribonucleic acid \[RNA\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection
Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are modified ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for emergency use) are not allowed
Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded
What this trial measures
- Incidence of adverse events (Phase 2a)Up to 30 days after last dose
Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by cohort and grade using frequencies and relative frequencies.
- Accumulation of effusion (Phase 2b)Up to 3 years
Will determine the effect of therapy on accumulation of effusion measured by total volume removed every 3 weeks. The change in accumulation of effusion (relative to pre-treatment) will be modeled as a function of cohort, time-point, their two-way interaction, baseline levels, and a random subject effect using a linear mixed model. The change will be compared: a) over-time within each cohort, and b) between the control cohort (cohort C) and each dosing cohort (cohorts A and B) using two-sided Bonferroni or Dunnet adjusted tests about the appropriate contrasts of model estimates. The model assumptions will be evaluated graphically, and transformations will be applied as appropriate.