Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment (ALISON)
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ClinicalTrials.gov Identifier: NCT04739527 |
Recruitment Status :
Recruiting
First Posted : February 4, 2021
Last Update Posted : November 28, 2022
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 8, 2021 | ||||||||
First Posted Date ICMJE | February 4, 2021 | ||||||||
Last Update Posted Date | November 28, 2022 | ||||||||
Actual Study Start Date ICMJE | June 10, 2021 | ||||||||
Estimated Primary Completion Date | June 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change from baseline DCP_001 vaccine antigen-specific T cells in the peripheral blood (systemic induction / expansion of DCP_001 vaccine antigen-specific T cells) [ Time Frame: A PBMC collection is planned at baseline, before start treatment. Further PBMC collections are scheduled during (4 times) and after the vaccinations. ] Systemic DCP-001 vaccine specific response is measured by the number of patients with de novo or increased immune responses based on IFNƴ ELISpot assay in any or more of the post-vaccination PBMC samples to at least one of the following DCP-001 vaccine antigens compared to baseline: WT-1, Survivin, RHAMM or PRAME, specific cancer testis antigens as NY-ESO1 and MAGE3.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment | ||||||||
Official Title ICMJE | An Open Label, Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-based Vaccine (DCP-001) in High Grade Serous Ovarian Cancer Patients After Primary Treatment | ||||||||
Brief Summary | Phase I study to evaluate safety and systemic immunogenicity of the DCP-001 vaccine in patients with high grade serous ovarian cancer after primary treatment. | ||||||||
Detailed Description | This is a first phase I study in HGSOC patients with primary disease eligible for standard of care treatment with either; complete or optimal primary cytoreductive surgery followed by 6 cycles of adjuvant chemotherapy (carboplatin/paclitaxel); or 3 cycles of neoadjuvant chemotherapy (carboplatin/paclitaxel) followed by complete or optimal cytoreductive interval surgery and 3 additional cycles carboplatin/paclitaxel. In the current study, DCP-001 vaccinations will be scheduled after standard of care treatment, starting 6 weeks after the last cycle of chemotherapy. Patients will receive 4 vaccinations containing 25E6 DCP-001 cells per vaccination followed by 2 additional booster vaccinations of 10E6 cells. Each patient will be followed up for 24 months. Safety will be monitored throughout the study. Systemic immune responses are determined by standard immune assays using peripheral blood mononuclear cells (PBMCs) and serum collected before, during and after vaccinations. Progression of disease will be monitored according to standard-of-care follow-up. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: Open label phase I study Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Ovarian Cancer | ||||||||
Intervention ICMJE | Biological: DCP-001
allogeneic dendritic cell vaccine
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Study Arms ICMJE | Experimental: Treatment arm
Patients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
Intervention: Biological: DCP-001
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
17 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 1, 2026 | ||||||||
Estimated Primary Completion Date | June 1, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: Patients with autoimmune-related hyperthyroidism, autoimmune-related hypothyroidism who are in remission, or on a stable dose of thyroid-replacement hormone, vitiligo, or psoriasis may be included.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Netherlands | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04739527 | ||||||||
Other Study ID Numbers ICMJE | ALISON-UMCG-01 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Hans W. Nijman, MD PHD, University Medical Center Groningen | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | University Medical Center Groningen | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Mendus | ||||||||
Investigators ICMJE |
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PRS Account | University Medical Center Groningen | ||||||||
Verification Date | November 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |