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Studies

Observational Recruiting

NCT07302607 on ClinicalTrials.gov

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

  • Sponsor: Hôpital d'Hautepierre
  • Enrollment: 221 (Estimated)
  • Study start: 2024-12-11 (Actual)
  • Primary completion: 2026-01-01 (Estimated)
  • Study completion: 2026-01-01 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

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.

Conditions

  • Stage III Melanoma

Primary Outcome Measures

  • Response Evaluation Criteria in Solid Tumors (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

Countries

France

Locations and Investigators