Predictive Factors of Complete Response to Immunotherapy in Metastatic Melanoma: a Single-center Retrospective Study Between 2013 and 2021
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 221
- Locations
- 1
- Primary Endpoint
- Response Evaluation Criteria in Solid Tumors
Study Overview
Brief 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. In this study, the investigators aim to identify other response factors not yet evaluated in the literature.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported