Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Cutaneous Merkel Cell Carcinoma (VIRASKIN)

November 18, 2025 updated by: Assistance Publique - Hôpitaux de Paris

Validation of in Vitro Method for Anti-MCPyV Immunotherapy on Patients With Merkel Cell Carcinoma of Skin

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The aim of the study is to test and validate in vitro a cell therapy approach for MCPyV+ Merkel Cell Carcinoma patients.

Study Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • Dermato-oncology Department, Ambroise Paré Hospital, APHP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients of Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or with an active follow-up beside dermatologist.

Description

Inclusion Criteria:

  • Patients >= 18 years old;
  • Diagnosed with Merkel cell carcinoma of skin, ongoing for local treatment, systemic treatment, complementary treatment or an active follow-up;
  • Informed for the study and no-opposed for participation;
  • Affiliated with a social security scheme or in an equivalent situation.

Exclusion Criteria:

  • Patients ongoing another interventional clinical trial;
  • Patients under guardianship or trusteeship;
  • Pregnancy or breastfeed;
  • Patients refusal.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-MCPyV functionality
Time Frame: Day 0 and Day 4
Anti-MCPyV functionality, including cytotoxicity, of T cells obtained after in vitro culture.
Day 0 and Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Astrid Blom, MD, Dermato-oncology Department, Ambroise Paré Hospital, APHP
  • Study Director: Yassine Taoufik, MD, PhD, U1186 INSERM, PAUL BROUSSE Hospital, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 13, 2025

First Posted (Actual)

January 17, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP240470
  • 2024-A00643-44 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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