Early anti-PD1 therapy before surgery in high-risk stage II melanoma
Official title: NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
Run by AC Camargo Cancer Center · NCT07680699 · Data updated 2026-11-12
This study looks at real-world patients with high-risk stage II melanoma to see if starting anti-PD1 therapy before surgery changes outcomes compared with the usual timing.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | April 23, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | July 2, 2026 |
| Trial ID | NCT07680699 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with high-risk stage IIB/IIC or stage III (N1c) cutaneous melanoma managed in routine clinical practice.
✕Probably not a fit
Patients without benefit may be those with limited data access, rapid disease progression, or events not influenced by timing of therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an ambispective observational cohort study using data from routine clinical care to compare outcomes between patients who started anti-PD1 therapy before surgery and those who followed the standard timing. No treatments are assigned by the study; all decisions are made by treating physicians. Outcomes of interest include recurrence-free survival, overall survival, and pathological response, analyzed descriptively. The retrospective arm reflects standard practice after surgery, while the prospective arm includes patients who began anti-PD1 therapy prior to surgery. Eligible adults with histologically confirmed cutaneous melanoma at high risk are included, with outcomes tracked in routine follow-up.
Why it matters
Potential benefit: If early anti-PD1 therapy before surgery shows favorable outcomes, patients might experience longer survival or better disease control.
How similar studies have gone: Observational studies in real-world settings have explored timing of immunotherapy with mixed results; this study contributes descriptive comparisons rather than causal conclusions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice. Exclusion Criteria: * Patients without sufficient clinical or follow-up data. * Patients who do not provide informed consent (for prospective cohort).
Where it's running
-
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.