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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT05231122
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ovarian Clear Cell Adenocarcinoma
  • Platinum-Sensitive Ovarian Carcinoma
  • Recurrent Endometrial Serous Adenocarcinoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Fallopian Tube Serous Adenocarcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Ovarian Clear Cell Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian Serous Adenocarcinoma
  • Recurrent Platinum-Resistant Ovarian Carcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
  • Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
  • Recurrent Primary Peritoneal Serous Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-CD40 Agonist Monoclonal Antibody CDX-1140 — BIOLOGICAL
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Quality-of-Life Assessment — OTHER
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Mar 12, 2024
Status verified
May 2026
Primary completion
Mar 15, 2027
Completion
Mar 15, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (pembrolizumab, bevacizumab)
    Patients receive pembrolizumab IV over 30 minutes and bevacizumab IV over 30-90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity.
  • Experimental: Arm II (pembrolizumab, bevacizumab, CDX-1140)
    Patients receive pembrolizumab IV over 30 minutes, bevacizumab IV over 30-90 minutes, and CDX-1140 IV over 90 minutes on day 1. Cycles repeat every 3 weeks until disease progression or development of unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 2 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Emese Zsiros
[email protected]
716-845-8337
Emese Zsiros (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Amir A. Jazaeri
[email protected]
877-632-6789
Amir A. Jazaeri (PRINCIPAL_INVESTIGATOR)

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Roswell Park Cancer Institute· Buffalo, NYM D Anderson Cancer Center· Houston, TX

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