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Recruiting Phase 2 NCT05231122

Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer

Trial Parameters

Condition Ovarian Clear Cell Adenocarcinoma
Sponsor Roswell Park Cancer Institute
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 80
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-03-12
Completion 2026-12-30
Interventions
Anti-CD40 Agonist Monoclonal Antibody CDX-1140BevacizumabPembrolizumab

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Age \>= 18 years of age. * Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. * Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of treatment, and BRCA status must be known. Neoadjuvant + adjuvant is considered one line. * Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance. * Participants may have received a prior anti-PD1/anti-PDL1 therapy or bevacizumab, these will not be considered a separate line of therapy. * Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy. * Hormonal therapy for OC (e.g. Tamoxifen, aromatase inhibitors etc.) will not count as a separate line of prior therapy. * Anticipated lifespan greater than 6 months. * Have an Eastern Cooperative Onc

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