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

NCT04739527 | Completed Phase 1 DMC

• 1 other identifier: ALISON-UMCG-01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (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)

  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.

  A PBMC collection is planned at baseline, before start treatment. Further PBMC collections are scheduled during (4 times) and after the vaccinations.

Secondary Outcomes (3)

• Safety and tolerability of the repetitive doses of the DCP-001 vaccine

  Up to 28 days after last vaccination

• Recurrence free survival (RFS)

  Up to 2 years from disease diagnosis

• Overall survival (OS)

  Up to 2 years from disease diagnosis

Study Arms (1)

Treatment arm

EXPERIMENTAL

Patients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination

Biological: DCP-001

Interventions

DCP-001 BIOLOGICAL

allogeneic dendritic cell vaccine

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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 ≥ 18 years
• Signed informed consent form (ICF) in accordance with institutional and regulatory guidelines

You may not qualify if:

• 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 with gamma globulin and without chronic or recurrent infection) is allowed.
• Patients with known HIV who have controlled infection (undetectable viral load and CD4 count above 350 either spontaneously or on a stable antiviral regimen) are permitted. For patients with controlled HIV infection, monitoring will be performed per local standards.
• Patients with known hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving antiviral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA per local standards. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of trial treatment.
• Patients who are known hepatitis C virus antibody positive (HCV Ab+) who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) are permitted.
• Liver or renal function abnormalities that are considered to be clinically relevant by the investigator.
• Abnormal blood levels (neutropenia among other things) due to chemotherapy that are considered to be clinically relevant by the investigator.
• If so, blood levels will be repeated in 1-2 weeks, in case blood levels are normalized the patient is allowed to be included in the study. In case of persistent abnormal blood levels the patient will be excluded.
• Use of systemic continuous corticosteroid therapy (e.g. prednisone i.v. or p.o. \>7.5 mg / day).
• Participation in a trial with another investigational drug within 30 days prior to the enrolment in this trial
• Any condition that in the opinion of the investigator could interfere with the conduct of the trial.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Mendus: collaborator

Study Sites (1)

UMCG

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Hans W Nijman, MD/PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label phase I study

Study Record Dates

• First Submitted: January 8, 2021
• First Posted: February 4, 2021
• Study Start: June 10, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)