Cutaneous MelanomaNEOSENTNCT07680699
NEOSENT: Early Anti-PD-1 Therapy In High-Risk Stage II Melanoma
An observational study of Cutaneous Melanoma, run by AC Camargo Cancer Center at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Melanoma
- What is being tested?
- Anti-PD1 Therapy Timing
- How many people
- 250 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Apr 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.
Who may be able to join
- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.
Who cannot join
- Patients without sufficient clinical or follow-up data.
- Patients who do not provide informed consent (for prospective cohort).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
AC Camargo Cancer Center
São Paulo, São Paulo
MILTON SILVA, +55 11 99427-0884, milton.silva@accamargo.org.br
About this study
Official title: NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
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.
Read the detailed description
This study evaluates the association between the timing of anti-PD1 therapy initiation and clinical outcomes in patients with high-risk stage II melanoma (stages IIB and IIC) and/or microsatellitosis.
The study is designed as an ambispective observational cohort, including both retrospective and prospective patients treated in routine clinical practice.
The retrospective cohort includes patients who were managed according to standard clinical practice, typically undergoing surgical treatment followed by systemic/adjuvant anti-PD1 therapy. The prospective cohort includes patients who initiated anti-PD1 therapy prior to surgery, based on the treating physician's clinical judgment.
All treatment decisions, including the timing of systemic therapy initiation, are made independently by the treating physician and are not influenced by the study protocol. No interventions are assigned as part of the study, and no experimental treatment strategies are implemented.
Patients are categorized according to the timing of anti-PD1 therapy initiation (before surgery or according to standard timing), and outcomes are compared descriptively between these groups.
The study aims to explore whether early initiation of systemic therapy in routine clinical practice is associated with differences in time to treatment initiation and key clinical outcomes, including recurrence-free survival, overall survival, and pathological response.
Given its observational design, the study does not aim to establish causality but rather to generate real-world evidence regarding the potential impact of early anti-PD1 therapy in this high-risk population. As a non-randomized observational study, the results may be subject to confounding factors and selection bias inherent to real-world clinical practice.
- Conditions
- Cutaneous Melanoma
- Being tested
- Anti-PD1 Therapy Timing
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-PD1 Therapy TimingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Anti-PD1 Therapy Timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of systemic therapy
Time from date of diagnosis to the start of systemic or adjuvant therapy.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start23 Apr 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AC Camargo Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680699
- Sponsor's protocol ID
- NEOSENT-ACC-2025
- Acronym
- NEOSENT
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NEOSENT - Early Anti-PD-1 Therapy In Patients With High-Risk Stage II Melanoma And/Or Microsatellitosis: An Ambispective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07680699
- Acronym / sponsor ID
- NEOSENT / NEOSENT-ACC-2025
- Conditions
- Cutaneous Melanoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- AC Camargo Cancer CenterUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study evaluates the association between the timing of anti-PD1 therapy initiation and clinical outcomes in patients with high-risk stage II melanoma (stages IIB and IIC) and/or microsatellitosis.
The study is designed as an ambispective observational cohort, including both retrospective and prospective patients treated in routine clinical practice.
The retrospective cohort includes patients who were managed according to standard clinical practice, typically undergoing surgical treatment followed by systemic/adjuvant anti-PD1 therapy. The prospective cohort includes patients who initiated anti-PD1 therapy prior to surgery, based on the treating physician's clinical judgment.
All treatment decisions, including the timing of systemic therapy initiation, are made independently by the treating physician and are not influenced by the study protocol. No interventions are assigned as part of the study, and no experimental treatment strategies are implemented.
Patients are categorized according to the timing of anti-PD1 therapy initiation (before surgery or according to standard timing), and outcomes are compared descriptively between these groups.
The study aims to explore whether early initiation of systemic therapy in routine clinical practice is associated with differences in time to treatment initiation and key clinical outcomes, including recurrence-free survival, overall survival, and pathological response.
Given its observational design, the study does not aim to establish causality but rather to generate real-world evidence regarding the potential impact of early anti-PD1 therapy in this high-risk population. As a non-randomized observational study, the results may be subject to confounding factors and selection bias inherent to real-world clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Anti-PD1 Therapy Before Surgery | – | Other: Anti-PD1 Therapy TimingPatients 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. |
| Standard Timing Group | – | Other: Anti-PD1 Therapy TimingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with high-risk stage II cutaneous melanoma (stages IIB and IIC) and/or microsatellitosis treated in routine clinical practice.
Key inclusion criteria (1 listed)
- Adults (≥18 years) with histologically confirmed cutaneous melanoma stage IIB or IIC or stage III (N1c), managed in routine clinical practice.
Key exclusion criteria (2 listed)
- Patients without sufficient clinical or follow-up data.
- Patients who do not provide informed consent (for prospective cohort).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-PD1 Therapy TimingThis 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. | Other | Early Anti-PD1 Therapy Before Surgery, Standard Timing Group |
Primary outcome
Time to initiation of systemic therapy
Time frame: Up to 12 months
Time from date of diagnosis to the start of systemic or adjuvant therapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanoma, run by AC Camargo Cancer Center at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to initiation of systemic therapy (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.