Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer
Roswell Park Cancer Institute
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.
Description
PRIMARY OBJECTIVES: I. Determine the safety of anti-CD40 agonist monoclonal antibody CDX-1140 (CDX-1140) combined with pembrolizumab and bevacizumab in patients with recurrent ovarian cancer (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0). II. Determine the objective response rate (ORR) per immune related response criteria (immune-modified Response Evaluation Criteria in Solid Tumors \[iRECIST\]). SECONDARY OBJECTIVES: I. Determine progression free survival (PFS), disease control rate (DCR) and overall survival (OS). II. Changes in quality of life measures during th…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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 bevacizum…
Interventions
- BiologicalAnti-CD40 Agonist Monoclonal Antibody CDX-1140
Given IV
- BiologicalBevacizumab
Given IV
- BiologicalPembrolizumab
Given IV
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Locations (2)
- Roswell Park Cancer InstituteBuffalo, New York
- M D Anderson Cancer CenterHouston, Texas