NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
This is an observational cohort study evaluating clinical and pathological outcomes in patients with high-risk stage II melanoma. Patients are included after receiving treatment as part of routine clinical practice. Decisions about treatment, including whether to start anti-PD1 therapy before surgery, are made by the treating physician and are not influenced by the study. The study compares outcomes between patients who started anti-PD1 therapy before surgery and those treated according to the usual timing in clinical practice. No treatments are assigned as part of the study.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• \- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.
Locations
Other Locations
Brazil
AC Camargo Cancer Center
RECRUITING
São Paulo
Time Frame
Start Date: 2025-04-23
Estimated Completion Date: 2027-05
Participants
Target number of participants: 250
Treatments
Early Anti-PD1 Therapy Before Surgery
Patients who initiated anti-PD1 therapy prior to surgery, based on routine clinical decision-making. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Standard Timing Group
Patients who underwent surgery followed by systemic/adjuvant anti-PD1 therapy according to standard clinical practice. Group classification is based on the timing of anti-PD1 therapy initiation in relation to surgical treatment.
Related Therapeutic Areas
Sponsors
Leads: AC Camargo Cancer Center