Finding studies
Finding studies
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Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Mayo Clinic
With
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) on day 1 of cycles 1-5 and pembrolizumab intravenously (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 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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
