Melanoma (Skin Cancer)Phase 2NeoSentiNCT07448831
A Phase II Clinical Trial on Neo-adjuvant Pembrolizumab in Patients With pT3b-T4a/b cN0M0 Melanoma.
A Phase 2 study testing Pembrolizumab in people with Melanoma (Skin Cancer), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin Cancer)
- What is being tested?
- Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Apr 2025to Dec 2029
- Phase
- Phase 2
- 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
Who may be able to join
- ≥ 18 years of age on the day of signing the informed consent.
- Histologically confirmed high risk primary cutaneous pT1b-4b melanoma High risk primary melanoma is defined in this study as the following AJCC8 T-stages:
- pT1b-3a, with a poor prognostic score on the Merlin™ test ("Merlin™ high risk");
- pT3b-4b, irrespective of their Merlin™ test result
- Amendable to sentinel lymph node biopsy.
- No evidence of metastatic dissemination as demonstrated by PET/CT, ultrasound of the draining lymph node basin, and clinical examination.
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- No prior exposure to systemic treatment for melanoma (adjuvant or curative).
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1 or 2 assessed within 7 days prior to the first dose of study treatment.
- Adequate baseline organ function as defined by local institutional standards.
- Women:
- Female patients must be surgically sterile or be postmenopausal (A postmenopausal state is defined as no menses for 12 months without an alternative medical cause).
- If a female patient is a woman of childbearing potential (WOCBP) they must agree to use highly effective contraception measures during the period of therapy, which should be continued for at least 4 months following the last dose of pembrolizumab as indicated in the SmPC. A list of highly effective contraceptive measures is included in appendix 1 All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to enrollment and pregnancy testing should be conducted within 24h prior to the first dose of immune checkpoint inhibitors and thereafter monthly until 4 months following the last dose study treatment.
- Should not be breastfeeding at screening or during study treatment.
- Men with a female partner of childbearing potential must agree to use highly effective contraception from 14 days prior to administration of the first dose of study treatment or have either had a prior vasectomy, throughout the treatment period, and for 16 weeks after the last dose of study treatment.
- Capable of providing documented informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Patients with uveal melanoma, mucosal melanoma and melanoma of unknown primary origin.
- Active autoimmune disease requiring systemic treatment.
- Patients with a history of previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 3 years prior to screening and no additional therapy is required or anticipated to be required during the study period.
- Known Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: subjects with laboratory evidence of cleared HBV and HCV infection will be permitted.
- Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
- Active infection at the time of screening (e.g. wound infection).
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- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatment, or excipients.
- History of organ allograft.
- Patients who have previously been exposed to checkpoint inhibitors.
- Prior transplantation of human cells, tissues and organs (e.g. liver transplant) or candidates for any type of transplantation.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Any contra-indication for evaluation by whole body 18F-FDG-PET/CT or MRI.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Jette, Brussels Capital, 1090
Prof. Dr. Bart Neyns, +32 2 477 60 40, bart.neyns@uzbrussel.be
About this study
Official title: A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination.
This study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans. Participants receive a single infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy. The goal is to see if this early treatment can reduce or eliminate tiny cancer cells that might already be in the lymph nodes but are too small to detect.
After surgery, patients whose melanoma stage normally requires further treatment will continue with standard immunotherapy for one year. Others will move directly into follow-up care. All participants are monitored closely for five years with regular scans, blood tests, and check-ups to watch for any signs of recurrence and to ensure their safety.
Read the detailed description
The NeoSenti study is a clinical trial exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help improve outcomes for people with high-risk melanoma. Pembrolizumab is a treatment that strengthens the immune system so it can better recognize and attack cancer cells. It is already used after surgery for certain melanoma stages, but this study aims to find out whether giving it earlier-before the sentinel lymph node biopsy-can reduce the chance that melanoma has already spread microscopically.
Adults with high-risk primary melanoma who do not show any signs of cancer spread on physical examination or scans may be eligible to participate. Before joining, patients undergo blood tests, a PET/CT scan, an ultrasound of the lymph node area, and a review of their melanoma features. Some patients will also have a Merlin™ genetic test to determine whether their tumor carries a high risk of spreading.
Participants who qualify receive a single infusion of pembrolizumab six weeks before their planned surgery. This "pre-surgery" (neoadjuvant) treatment is intended to give the immune system time to attack melanoma cells that may be in the lymph nodes but are too small to detect. About six weeks later, patients undergo surgery, including a sentinel lymph node biopsy-used to check whether melanoma has started to spread-and, if needed, a wide local excision to remove additional tissue around the original melanoma.
The results of the surgery determine the next steps. Patients whose cancer is classified as stage IIB, IIC, or III after surgery will continue with standard immunotherapy every six weeks for one year. Patients with stage IB or IIA melanoma will not need additional treatment and will move directly into follow-up care. Regardless of stage, all participants are monitored very closely for five years. This follow-up includes regular physical examinations, blood tests, full-body imaging every four months (PET/CT or whole-body MRI), and optional questionnaires about quality of life and cognitive function. Some patients may also have blood tests that measure tiny amounts of tumor DNA (ctDNA), which might help predict the risk of recurrence.
- Conditions
- Melanoma (Skin Cancer)
- Being tested
- Pembrolizumab
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
One administration of intravenous pembrolizumab 400 mg.
| Study group | Role | What they receive |
|---|---|---|
| High-risk primary cutaneous melanoma | Experimental | pT1b-3a Merlin high-risk and pT3b-4b Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antitumor activity of pembrolizumab
To estimate the antitumor activity of pembrolizumab in high-risk primary cutaneous melanoma population (pT1b to pT4b) without clinical evidence of metastasis (cN0M0) in the neoadjuvant setting.
Measured: A period of 7 weeks
Secondary outcomes (9)
Relapse-free survival
To estimate relapse-free survival (RFS), defined as the time from study recruitment to the date of first recurrence (or death from any cause), over a period of five years.
Measured: A period of 5 years
Adverse events
To document the incidence and severity of adverse events in study patients as assessed by anamnesis, clinical examination, analysis of blood and any additional medical examination that is indicated.
Measured: For up to 3 years from the date of last dose of study treatment or until the death or lost to follow-up
Health-Related Quality of Life (HRQoL)
Measurement of health-related quality of life (HRQoL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30). The score on the EORTC-QLQ-C30 scale (range: 0-100). Higher scores indicate better health-related quality of life.
Measured: Baseline, 6 months, 16 months.
Presence of cell-free circulating tumor DNA
To measure the presence of cell-free circulating tumor DNA (ctDNA) with digital-droplet PCR to correlate the presence/absence of ctDNA with the risk of relapse or death measured by RFS, DMFS, OS.
Measured: At baseline, each 6 weeks during the adjuvant treatment phase before every treatment cycle, each 4 months during the follow-up phase and/or at relapse.
Distant-metastasis free survival
To estimate distant-metastasis free survival (DMFS), from recruitment to the first diagnosis of a distant metastasis (or death from any cause), over a period of five years.
Measured: A period of 5 years
Overall survival
To estimate overall survival (OS), defined as the time of recruitment until the date of death from any cause, over a period of five years.
Measured: A period of 5 years
Fear of Cancer Recurrence
Measurement of the fear of cancer recurrence through the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF). The score on the FCRI-SF (range: 0-84). Higher scores indicate greater fear of cancer recurrence.
Measured: Baseline, 6 months, 16 months.
Subjective Neurocognitive Functioning
Measurement of subjective neurocognitive functioning through the Cognitive Failures Questionnaire (CFQ). The score on the CFQ (range: 0-100).Higher scores indicate greater subjective cognitive impairment or failure.
Measured: Baseline, 6 months, 16 months.
Objective Neurocognitive Functioning
Measurement of objective neurocognitive functioning through the Amsterdam Cognition Scan (ACS), a computerized neuropsychological test battery. Raw scores or performance measures from the ACS (e.g., reaction time in milliseconds, accuracy percentage, or composite scores). Higher accuracy or quicker response times indicate better neurocognitive functioning.
Measured: Baseline, 6 months, 16 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start17 Apr 2025
- Primary completion30 Jun 2026 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin Cancer)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bart Neyns, Prof, MD, PhD, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07448831
- Sponsor's protocol ID
- NeoSenti
- Other IDs
- 2024-517840-68
- Acronym
- NeoSenti
- Status last verified
- Dec 2025
- First submitted
- 9 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination.
- ClinicalTrials.gov ID
- NCT07448831
- Acronym / sponsor ID
- NeoSenti / NeoSenti
- Conditions
- Melanoma (Skin Cancer)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 4 Mar 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 study, called NeoSenti, is exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help the immune system fight melanoma more effectively. The study includes adults with high-risk melanoma who do not show any signs of the cancer having spread on scans. Participants receive a single infusion of pembrolizumab six weeks before their scheduled sentinel lymph node biopsy. The goal is to see if this early treatment can reduce or eliminate tiny cancer cells that might already be in the lymph nodes but are too small to detect.
After surgery, patients whose melanoma stage normally requires further treatment will continue with standard immunotherapy for one year. Others will move directly into follow-up care. All participants are monitored closely for five years with regular scans, blood tests, and check-ups to watch for any signs of recurrence and to ensure their safety.
Detailed description
The NeoSenti study is a clinical trial exploring whether giving one dose of the immunotherapy drug pembrolizumab before surgery can help improve outcomes for people with high-risk melanoma. Pembrolizumab is a treatment that strengthens the immune system so it can better recognize and attack cancer cells. It is already used after surgery for certain melanoma stages, but this study aims to find out whether giving it earlier-before the sentinel lymph node biopsy-can reduce the chance that melanoma has already spread microscopically.
Adults with high-risk primary melanoma who do not show any signs of cancer spread on physical examination or scans may be eligible to participate. Before joining, patients undergo blood tests, a PET/CT scan, an ultrasound of the lymph node area, and a review of their melanoma features. Some patients will also have a Merlin™ genetic test to determine whether their tumor carries a high risk of spreading.
Participants who qualify receive a single infusion of pembrolizumab six weeks before their planned surgery. This "pre-surgery" (neoadjuvant) treatment is intended to give the immune system time to attack melanoma cells that may be in the lymph nodes but are too small to detect. About six weeks later, patients undergo surgery, including a sentinel lymph node biopsy-used to check whether melanoma has started to spread-and, if needed, a wide local excision to remove additional tissue around the original melanoma.
The results of the surgery determine the next steps. Patients whose cancer is classified as stage IIB, IIC, or III after surgery will continue with standard immunotherapy every six weeks for one year. Patients with stage IB or IIA melanoma will not need additional treatment and will move directly into follow-up care. Regardless of stage, all participants are monitored very closely for five years. This follow-up includes regular physical examinations, blood tests, full-body imaging every four months (PET/CT or whole-body MRI), and optional questionnaires about quality of life and cognitive function. Some patients may also have blood tests that measure tiny amounts of tumor DNA (ctDNA), which might help predict the risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk primary cutaneous melanoma | Experimental | Drug: PembrolizumabpT1b-3a Merlin high-risk and pT3b-4b |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥ 18 years of age on the day of signing the informed consent.
- Histologically confirmed high risk primary cutaneous pT1b-4b melanoma High risk primary melanoma is defined in this study as the following AJCC8 T-stages:
- pT1b-3a, with a poor prognostic score on the Merlin™ test ("Merlin™ high risk");
- pT3b-4b, irrespective of their Merlin™ test result
- Amendable to sentinel lymph node biopsy.
Key exclusion criteria (13 listed)
- Patients with uveal melanoma, mucosal melanoma and melanoma of unknown primary origin.
- Active autoimmune disease requiring systemic treatment.
- Patients with a history of previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 3 years prior to screening and no additional therapy is required or anticipated to be required during the study period.
- Known Human Immunodeficiency Virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Exception: subjects with laboratory evidence of cleared HBV and HCV infection will be permitted.
- Any serious or unstable pre-existing medical conditions (aside from malignancy exceptions specified above), psychiatric disorders, or other conditions that could interfere with the subject's safety, obtaining informed consent, or compliance with study procedures.
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 |
|---|---|---|
| PembrolizumabOne administration of intravenous pembrolizumab 400 mg. | Drug | High-risk primary cutaneous melanoma |
Primary outcome
Antitumor activity of pembrolizumab
Time frame: A period of 7 weeks
To estimate the antitumor activity of pembrolizumab in high-risk primary cutaneous melanoma population (pT1b to pT4b) without clinical evidence of metastasis (cN0M0) in the neoadjuvant setting.
9 secondary outcomes
Relapse-free survival
Time frame: A period of 5 years
Adverse events
Time frame: For up to 3 years from the date of last dose of study treatment or until the death or lost to follow-up
Health-Related Quality of Life (HRQoL)
Time frame: Baseline, 6 months, 16 months.
Presence of cell-free circulating tumor DNA
Time frame: At baseline, each 6 weeks during the adjuvant treatment phase before every treatment cycle, each 4 months during the follow-up phase and/or at relapse.
Distant-metastasis free survival
Time frame: A period of 5 years
Overall survival
Time frame: A period of 5 years
Fear of Cancer Recurrence
Time frame: Baseline, 6 months, 16 months.
Subjective Neurocognitive Functioning
Time frame: Baseline, 6 months, 16 months.
Objective Neurocognitive Functioning
Time frame: Baseline, 6 months, 16 months.
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 9 Mar 2026.
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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.
Bart Neyns, Prof, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab in people with Melanoma (Skin Cancer), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 15 inclusion and 13 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 9 Mar 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Antitumor activity of pembrolizumab (time frame: A period of 7 weeks). 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 9 Mar 2026.