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

Summary

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.

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 Clear Cell Adenocarcinoma
• Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
• Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
• Recurrent Primary Peritoneal Carcinosarcoma

Interventions

PROCEDURE

Biopsy

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Given ID

BIOLOGICAL

Pembrolizumab

Given IV

PROCEDURE

Pheresis

Undergo apheresis

Sponsors & Collaborators

• NanoPass Technologies Ltd

  collaborator INDUSTRY

• National Cancer Institute (NCI)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Matthew S. Block, MD, PhD · Mayo Clinic in Rochester

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-28

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations