Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639074
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Folate Receptor Alpha Dendritic Cells FRαDCs or Placebo for the Treatment of Patients With Stage III or IV Ovarian Fallopian Tube or Primary Peritoneal Cancer FAROUT Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Folate Receptor Alpha Dendritic Cells FRαDCs or Placebo for Patients With Advanced Stage Ovarian Cancer A Phase II Double-Blind Randomized Clinical Trial FAROUT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
This phase II trial compares the effect of folate receptor alpha dendritic cells FRαDCs to placebo in treating patients with stage III or IV ovarian fallopian tube or primary peritoneal cancer FRαDCs a dendritic cell vaccine is made from a persons white blood cells The white blood cells are treated in the laboratory to make dendritic cells a type of immune cell mixed with folate receptor alpha FRalpha a protein found in high levels on ovarian tumor cells FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell Placebo is an inactive substance that looks the same as and is given the same way as the active drug or treatment being tested The effects of the active drug are compared to the effects of the placebo Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian fallopian tube or primary peritoneal cancer
Detailed Description:
PRIMARY OBJECTIVE
I Compare recurrence-free survival RFS in advanced ovarian carcinoma OC patients vaccinated with multi-epitope folate receptor alpha-loaded dendritic cell vaccine FRαDCs active vaccine versus placebo
SECONDARY OBJECTIVES
I Compare overall survival OS in advanced OC patients vaccinated with FRαDCs versus placebo
II Compare the adverse event AE profile of FRαDCs with that of placebo
CORRELATIVE RESEARCH OBJECTIVES
I Assess association of pre-existing immune microenvironment with RFS II Characterize the T cell and antibody responses to FRα and assess the association between the emergence of immunity and RFS
III Assess for epitope spreading and evaluate the association between epitope spreading and RFS
IV Compare archival tissue from surgery with post-recurrence biopsy tissue in those patients who develop recurrence to assess for common immune evasion mechanisms
V Evaluate differences in ribonucleic acid RNA expression of FRαDCs and its association with RFS
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients may receive tetanus and diphtheria vaccine Td or tetanus-diphtheria-accellular pertussis vaccine Tdap intramuscularly IM prior to undergoing leukapheresis Patients receive FRalphaDCs intradermally ID on day 1 of each cycle Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity Additionally patients undergo biopsy prior to apheresis and optionally at end of treatment and blood sample collection computed tomography CT andor magnetic resonance imaging MRI throughout the study
ARM II Patients may receive Td or Tdap IM prior to undergoing leukapheresis Patients receive placebo ID on day 1 of each cycle Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity Additionally patients undergo biopsy prior to apheresis and optionally at end of treatment and blood sample collection CT andor MRI throughout the study
After completion of study treatment patients are followed up every 3 months for up to month 36 then every 3 months until progression followed by every 6 months for up to year 8
I Compare recurrence-free survival RFS in advanced ovarian carcinoma OC patients vaccinated with multi-epitope folate receptor alpha-loaded dendritic cell vaccine FRαDCs active vaccine versus placebo
SECONDARY OBJECTIVES
I Compare overall survival OS in advanced OC patients vaccinated with FRαDCs versus placebo
II Compare the adverse event AE profile of FRαDCs with that of placebo
CORRELATIVE RESEARCH OBJECTIVES
I Assess association of pre-existing immune microenvironment with RFS II Characterize the T cell and antibody responses to FRα and assess the association between the emergence of immunity and RFS
III Assess for epitope spreading and evaluate the association between epitope spreading and RFS
IV Compare archival tissue from surgery with post-recurrence biopsy tissue in those patients who develop recurrence to assess for common immune evasion mechanisms
V Evaluate differences in ribonucleic acid RNA expression of FRαDCs and its association with RFS
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients may receive tetanus and diphtheria vaccine Td or tetanus-diphtheria-accellular pertussis vaccine Tdap intramuscularly IM prior to undergoing leukapheresis Patients receive FRalphaDCs intradermally ID on day 1 of each cycle Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity Additionally patients undergo biopsy prior to apheresis and optionally at end of treatment and blood sample collection computed tomography CT andor magnetic resonance imaging MRI throughout the study
ARM II Patients may receive Td or Tdap IM prior to undergoing leukapheresis Patients receive placebo ID on day 1 of each cycle Cycles repeat every 21 days for cycles 1-5 and then repeat every 91 days for cycles 6-12 in the absence of disease progression or unacceptable toxicity Additionally patients undergo biopsy prior to apheresis and optionally at end of treatment and blood sample collection CT andor MRI throughout the study
After completion of study treatment patients are followed up every 3 months for up to month 36 then every 3 months until progression followed by every 6 months for up to year 8
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None