Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021 (IMM)

December 10, 2025 updated by: University Hospital, Strasbourg, France
Although impressive progress has been made with this new therapeutic strategy, only a proportion of patients achieve a complete and sustained response. Studies have already identified predictive factors of treatment response that are now widely recognized. In this study, the investigators aim to identify other response factors not yet evaluated in the literature.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

221

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 Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service de dermatologie - Réanimation - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Cédric LENORMAND, MD
        • Principal Investigator:
          • Sixtine COLBACH, MD

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 subject with unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;
  • Curative immunotherapy treatment (anti-PD-1 and/or anti-CTLA-4);
  • Treatment and follow-up at the Dermatology Department of the Strasbourg University Hospitals;
  • Immunotherapy initiated between January 1, 2013, and December 31, 2021.

Exclusion Criteria:

  • Primary choroidal melanoma;
  • Adjuvant-intent immunotherapy;
  • Less than 3 months of follow-up after the start of immunotherapy;
  • Change of treatment before the first reassessment;
  • Treatment and follow-up at a department other than the Dermatology Department of the Strasbourg University Hospitals.

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
Response Evaluation Criteria in Solid Tumors
Time Frame: 1 hour after consultation

Response criteria

Based on assessment of target and non-target lesions, the disease can be classified as 8:

complete response (CR):

requires all of:

disappearance of all target and non-target lesions

pathological lymph nodes must have reduced to <10 mm in short axis

no new lesions

partial response (PR):

requires all of:

at least 30% decrease in SOD of target lesions compared to baseline sum diameters (BSD)

non-progressive disease of non-target lesions

no new lesions

progressive disease (PD):

either one of:

any new lesions

at least 20% relative and 5 mm absolute increase of SOD of target lesions compared to smallest SOD ever recorded for the patient

stable disease (SD):

not meeting criteria for PD or PR
1 hour after consultation

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

December 11, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9453

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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