A Study of FRaDCs for Ovarian Cancer

Status Recruiting

Clinical Trial Summary

The purpose of this study is to determine the response rate to the combination of folate receptor alpha dendritic cells (FRaDCs) plus pembrolizumab in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. Vaccines made from a person's peptide treated white blood cells may help the body build an effective immune response to kill tumor cells.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine whether the combination of FRalphaDCs and pembrolizumab has an acceptable toxicity profile in patients with recurrent ovarian cancer (OC). (Phase I) II. To measure the confirmed objective response rate (ORR) to the combination of FRalphaDCs and pembrolizumab in patients with recurrent OC. (Phase II) SECONDARY OBJECTIVES: I. To estimate the disease control rate (DCR-percentage of patients achieving a complete response, partial response, or stable disease) of the combination of FRalphaDCs and pembrolizumab in patients with recurrent OC. II. To estimate the duration of response (DoR) in patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. III. To estimate the progression-free survival (PFS) of patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. IV. To estimate the overall survival (OS) of patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. 2.25 To characterize the adverse event (AE) profile in patients with recurrent OC treated with the combination of FRalphaDCs and pembrolizumab. CORRELATIVE OBJECTIVES: I. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IL-17-secreting T cells (Th17s) in patients with recurrent OC. II. Characterize the T cell and antibody responses to FRalpha and assess the association between the emergence of immunity and recurrence-free (RFS). III. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IFNgamma-secreting T cells (Th1s) in patients with recurrent OC. IV. To determine whether the combination of FRalphaDCs and pembrolizumab induces an increase in the frequency of FRalpha-specific IgG antibodies in patients with recurrent OC. V. To determine whether the combination of FRalphaDCs and pembrolizumab induces changes in the immune microenvironment of ovarian tumors. OUTLINE: 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 intradermally (ID) and pembrolizumab intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) as well as blood sample collection throughout the trial. Patients undergo biopsy on study. Patients are followed up at 90 days after last dose, every 3 months until 24 months after registration or until progression of disease, and then every 6 months up to 5 years after registration. ;

Study Design

Related Conditions & MeSH terms

Adenocarcinoma
Carcinoma
Carcinoma, Endometrioid
Carcinosarcoma
Fallopian Tube Carcinosarcoma
Mixed Tumor, Mullerian
Primary Peritoneal Carcinosarcoma
Recurrence
Recurrent Fallopian Tube Carcinoma
Recurrent Fallopian Tube Clear Cell Adenocarcinoma
Recurrent Fallopian Tube Endometrioid Adenocarcinoma
Recurrent Ovarian Carcinoma
Recurrent Ovarian Carcinosarcoma
Recurrent Ovarian Clear Cell Adenocarcinoma
Recurrent Ovarian Endometrioid Adenocarcinoma
Recurrent Primary Peritoneal Carcinoma
Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma

Clinical Trial Details

NCT number	NCT05920798
Study type	Interventional
Source	Mayo Clinic
Contact	Clinical Trials Referral Office
Phone	855-776-0015
Email	mayocliniccancerstudies@mayo.edu
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	September 28, 2023
Completion date	July 15, 2027

View Details

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