Actively Recruiting
Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
Led by Roswell Park Cancer Institute · Updated on 2026-03-16
80
Participants Needed
2
Research Sites
146 weeks
Total Duration
On this page
Sponsors
R
Roswell Park Cancer Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolong survival, and improve quality of life in patients with ovarian cancer.
CONDITIONS
Official Title
Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Recurrent serous (low or high grade), endometrioid, or clear cell epithelial ovarian, fallopian tube, or primary peritoneal cancer
- Platinum-sensitive or platinum-resistant disease with no more than 4 prior treatment lines
- Known BRCA status
- Prior PARP inhibitor use allowed if given as maintenance
- Prior anti-PD1/PDL1 or bevacizumab therapy allowed
- Anticipated lifespan greater than 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Measurable disease per RECIST 1.1 criteria
- Resolved prior treatment toxicities to grade 1 or less, with some exceptions
- Adequate blood counts and organ function
- Willingness to undergo tumor biopsy before and during treatment
- Negative pregnancy test for women of childbearing potential
- Willingness to use two methods of birth control or be surgically sterile or abstain from heterosexual activity during study and for 6 months after last dose
- Ability to understand and sign informed consent
You will not qualify if you...
- Primary platinum-refractory disease
- Nonepithelial cancer types or certain rare ovarian tumors
- Recent use of other immunotherapies or monoclonal antibodies within defined periods
- Progression on prior immune checkpoint blockade therapy
- Recent radiation or major surgery within specified timeframes
- Immunodeficiency or current immunosuppressive treatments above specified doses
- Active untreated brain metastases or history of pneumonitis
- Severe allergic reactions to monoclonal antibodies
- Prior anti-CD40 antibody therapy
- Allergies to study drugs or their components
- Active autoimmune disease requiring recent systemic treatment
- Active or recent viral hepatitis or HIV infection
- Active infections requiring systemic therapy
- Use of investigational vaccines not licensed for emergency use
- Mental impairment affecting consent or compliance
- Serious non-healing wounds or fractures
- Significant cardiovascular disease or recent thromboembolic events
- Organ transplant recipients
- Gastrointestinal obstruction requiring nutrition support
- Pregnant or nursing females
- Active substance abuse
- Unwilling or unable to follow study requirements
- Any condition making the participant unsuitable for study treatment
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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