Clinical trial · Observational
NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma
NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD1 Therapy Timing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Early Anti-PD1 Therapy Before Surgery
- description
- 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.
- interventionNames
- Other: Anti-PD1 Therapy Timing
- label
- Standard Timing Group
- description
- 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.
- interventionNames
- Other: Anti-PD1 Therapy Timing
Primary outcomes (1)
- measure
- Time to initiation of systemic therapy
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available