AzTrials
AzTrials

Ovarian CancerPhase 1ALISONNCT04739527

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

A Phase 1 study testing DCP-001 in people with Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
DCP-001
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteNetherlands
Study dates
10 Jun 2021to 30 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • UMCG

    Groningen, Provincie Groningen, 9713GZ

Other trials in Netherlands

About this study

Official title: 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

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.

Read the 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.

Conditions
Ovarian Cancer
Being tested
DCP-001
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DCP-001Biological

    allogeneic dendritic cell vaccine

Study groups in NCT04739527
Study groupRoleWhat they receive
Treatment armExperimentalPatients receiving 4 bi-weekly vaccinations with 25E6 cells/vaccination of DCP-001, and 2 booster vaccinations with 10E6 cells/vaccination
Receives: Biological: DCP-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Safety and tolerability of the repetitive doses of the DCP-001 vaccine

    Number of patients with AEs, and SAEs

    Measured: Up to 28 days after last vaccination

  2. Recurrence free survival (RFS)

    RFS defined as the number of patients alive without any progress or recurrence (local or regional, or distant) and death due to any cause

    Measured: Up to 2 years from disease diagnosis

  3. Overall survival (OS)

    OS defined as the number of patients alive, measured in months, up to 2 years from disease diagnosis.

    Measured: Up to 2 years from disease diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start10 Jun 2021
  3. Primary completion30 Dec 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label phase I study
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739527
Sponsor's protocol ID
ALISON-UMCG-01
Acronym
ALISON
Status last verified
Apr 2026
First submitted
8 Jan 2021
Last updated
1 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DCP-001 in people with Ovarian Cancer, run by University Medical Center Groningen at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739527.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in