Phase 1 Study to Evaluate the Safety, Feasibility and Immunogenicity of an Allogeneic, Cell-basedā¦ (NCT04739527) | Clinical Trial Compass
CompletedPhase 1
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
Netherlands17 participantsStarted 2021-06-10
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Primary HGSOC patients (FIGO stage 3B to IV) who completed primary treatment defined as:
* primary debulking surgery (complete / optimal) and 6 cycles of adjuvant chemotherapy (carboplatin/paclitaxel)
* 3 cycles of neo-adjuvant chemotherapy (more NACT cycles to improve surgical outcome are allowed) followed by interval debulking surgery (complete / optimal) and 3 cycles of adjuvant chemotherapy (carboplatin/paclitaxel)
* Serum level CA125 \< 35 U/mL
* Age ā„ 18 years
* Signed informed consent form (ICF) in accordance with institutional and regulatory guidelines
Exclusion Criteria:
* History of a second malignancy except for curatively treated low-stage tumors with a histology that can be differentiated from the epithelial OC type
* Patients must have no ongoing or recent evidence (within the last 5 years) of significant autoimmune disease that required treatment with systemic immunosuppressive treatments which may suggest risk for immune-related adverse events (irAEs).
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.
* Patients must have no uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated withā¦
What they're measuring
1
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)
Timeframe: A PBMC collection is planned at baseline, before start treatment. Further PBMC collections are scheduled during (4 times) and after the vaccinations.