Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05920798
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Fallopian Tube Carcinosarcoma
  • Primary Peritoneal Carcinosarcoma
  • Recurrent Fallopian Tube Carcinoma
  • Recurrent Fallopian Tube Clear Cell Adenocarcinoma
  • Recurrent Fallopian Tube Endometrioid Adenocarcinoma
  • Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
  • Recurrent Ovarian Carcinoma
  • Recurrent Ovarian Carcinosarcoma
  • Recurrent Ovarian Clear Cell Adenocarcinoma
  • Recurrent Ovarian Endometrioid Adenocarcinoma
  • Recurrent Ovarian High Grade Serous Adenocarcinoma
  • Recurrent Primary Peritoneal Carcinoma
  • Recurrent Primary Peritoneal Carcinosarcoma
  • Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
  • Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
  • Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Biopsy — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine — BIOLOGICAL
    Given ID
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Pheresis — PROCEDURE
    Undergo apheresis

Study Details

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. While the majority of patients achieve a remission from ovarian cancer with the combination of aggressive cytoreductive surgery and cytotoxic chemotherapy, over 80% of patients develop recurrence within 3 years of completion of treatment. Additional treatments are needed for recurrence, but the standard treatment modalities are non-curative in nature due to the development of drug resistance. As such, there is a great unmet need for treatment strategies that utilize new mechanisms to which drug resistance does not develop. FRalphaDC is a dendritic cell vaccine that is made from the white blood cells collected from a procedure call apheresis. The white blood cells are treated to make dendritic cells, which will then be incubated with peptides, which are pieces of a protein known as "folate receptor alpha" (FRalpha), a protein that is found in high levels on ovarian cancer cells. Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the tumor cells by targeting the FRalpha protein. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving FRalphaDC vaccine with pembrolizumab may be a safe and effective treatment for recurrent ovarian cancer.

Key Dates

Start date
Sep 28, 2023
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (apheresis, FRalphaDC, pembrolizumab)
    Patients undergo apheresis for multi-epitope folate receptor alpha-loaded dendritic cell vaccine manufacturing on study. Patients then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID on day 1 of cycles 1-5 and pembrolizumab IV over 30 minutes on day 1 of cycles 1-8. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Patient then receive multi-epitope folate receptor alpha-loaded dendritic cell vaccine ID on day 1 of odd cycles and pembrolizumab IV over 30 minutes on day 1 of remaining cycles. Cycles repeat every 42 days for up to cycle 22 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI as well as blood sample collection throughout the trial. Patients undergo biopsy on study.

Primary Outcome Measure

Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile. [ Time Frame: Up to 21 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trials Referral Office
[email protected]
855-776-0015
Brenda J. Ernst, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Gerardo Colon-Otero, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Matthew S. Block, MD, PhD (PRINCIPAL_INVESTIGATOR)

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