Stage III MelanomaIMMNCT07302607
Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021
An observational study of Stage III Melanoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage III Melanoma
- How many people
- 221 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2024to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subject with unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de dermatologie - Réanimation - CHU de Strasbourg - France
Strasbourg, 67091
Cédric LENORMAND, MD, 33 3 88 11 66 27, cedric.lenormand@chru-strasbourg.fr
Cédric LENORMAND, MD
About this study
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.
- Conditions
- Stage III Melanoma
- Keywords
- Stage III Melanoma, Immunotherapy in Metastatic Melanoma, Metastatic melanoma (unresectable stage III and IV)
- Medical subject headings
- Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Evaluation Criteria in Solid Tumors
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
Measured: 1 hour after consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start11 Dec 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage III MelanomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 221 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302607
- Sponsor's protocol ID
- 9453
- Acronym
- IMM
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021
- ClinicalTrials.gov ID
- NCT07302607
- Acronym / sponsor ID
- IMM / 9453
- Conditions
- Stage III Melanoma
- Keywords
- Stage III Melanoma, Immunotherapy in Metastatic Melanoma, Metastatic melanoma (unresectable stage III and IV)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 221 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Dec 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subject with unresectable stage III or stage IV melanoma according to the AJCC classification - 8th edition;
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage III Melanoma, run by University Hospital, Strasbourg, France at 1 site in France.
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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 24 Dec 2025. 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 France. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cédric LENORMAND, MD (33 3 88 11 66 27, cedric.lenormand@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Evaluation Criteria in Solid Tumors (time frame: 1 hour after consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.