Health Trials

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

ConditionsOvarian Clear Cell AdenocarcinomaPlatinum-Sensitive Ovarian CarcinomaRecurrent Endometrial Serous AdenocarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Fallopian Tube Endometrioid AdenocarcinomaRecurrent Fallopian Tube Serous AdenocarcinomaRecurrent Ovarian CarcinomaRecurrent Ovarian Clear Cell AdenocarcinomaRecurrent Ovarian Endometrioid AdenocarcinomaRecurrent Ovarian Serous AdenocarcinomaRecurrent Platinum-Resistant Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaRecurrent Primary Peritoneal Clear Cell AdenocarcinomaRecurrent Primary Peritoneal Endometrioid AdenocarcinomaRecurrent Primary Peritoneal Serous Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRoswell Park Cancer Institute

About this trial

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

Qualifiers

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.

Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance.

Disqualifiers

Primary platinum-refractory patients are excluded

Has a nonepithelial cancer (germ cell tumors, sex cord-stromal tumors), borderline tumors, mucinous or seromucinous that is predominately mucinous, malignant Brenner's tumor, carcinosarcoma or undifferentiated carcinoma.

Receipt of any antibody targeting T cell checkpoint or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.

Has received prior systemic anticancer therapy (including investigational agents or maintenance therapy) within 28 days prior to the planned start of study treatment.

Trial design

Treatments tested in this trial

  • Anti-CD40 Agonist Monoclonal Antibody CDX-1140
  • Bevacizumab
  • Pembrolizumab
  • Quality-of-Life Assessment
  • Questionnaire Administration

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Roswell Park Cancer Institute

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Celldex Therapeutics

Collaborator

United States Department of Defense

Collaborator

Source ClinicalTrials.gov