Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920798
Status:
RECRUITING
Last Update Posted:
2023-10-02
First Post:
2023-06-09
Brief Title:
A Study of FRaDCs for Ovarian Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
FRαDCs Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 persons peptide treated white blood cells may help the body build an effective immune response to kill tumor cells
Detailed 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
225 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 andor 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
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
225 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 andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-03999 | REGISTRY | None | None |
| 22-000139 | OTHER | None | None |
| MC220601 | OTHER | Mayo Clinic | None |