NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma

NCT07680699 | Recruiting

• 1 other identifier: NEOSENT-ACC-2025
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cutaneous Melanoma

Outcome Measures

Primary Outcomes (1)

• Time to initiation of systemic therapy

  Time from date of diagnosis to the start of systemic or adjuvant therapy.

  Up to 12 months

Study Arms (2)

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.

Other: Anti-PD1 Therapy Timing

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.

Other: Anti-PD1 Therapy Timing

Interventions

Anti-PD1 Therapy Timing OTHER

This is an observational study variable. The timing of anti-PD1 therapy initiation in relation to surgery is determined by the treating physician as part of routine clinical practice. The study does not assign or modify any treatment.

Early Anti-PD1 Therapy Before Surgery; Standard Timing Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.

You may qualify if:

• \- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.

You may not qualify if:

• Patients without sufficient clinical or follow-up data.
• Patients who do not provide informed consent (for prospective cohort).

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2026
• First Posted: July 2, 2026
• Study Start: April 23, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)