Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Cutaneous Melanoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorAC Camargo Cancer Center
Academic / other
Locations1 site (São Paulo, São Paulo)
StatusRecruiting
StartedApril 23, 2025
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedJuly 2, 2026
Trial IDNCT07680699 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.