NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma
ConditionCutaneous Melanoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAC Camargo Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients without sufficient clinical or follow-up data.
Patients who do not provide informed consent (for prospective cohort).
Trial population
Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Anti-PD1 Therapy Timing
Other interventionThis 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Early Anti-PD1 Therapy Before Surgery1 intervention
Group B: Standard Timing Group1 intervention
Trial outcomes
Primary outcomes
1
Time to initiation of systemic therapy
Time from date of diagnosis to the start of systemic or adjuvant therapy.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov