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NCT07448831: NeoSenti
A Phase 2 Clinical Trial on Neoadjuvant Pembrolizumab in Patients Diagnosed With High-risk Melanoma Without Clinical Evidence of Metastatic Dissemination.
Phase 2 trial testing Pembrolizumab in Melanoma (Skin Cancer) in 49 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Universitair Ziekenhuis Brussel |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 49 |
| Start date | 17 April 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 1 December 2029 |
| Sites | 1 location across Belgium |
Drugs / interventions tested
- Pembrolizumab (pembrolizumab) — full drug profile →
Conditions studied
- Melanoma (Skin Cancer) — all drugs for Melanoma (Skin Cancer) →
Sponsor
Universitair Ziekenhuis Brussel — full company profile →
Who can join
18 and older, any sex, with Melanoma (Skin Cancer). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07448831
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Melanoma (Skin Cancer)
Currently open trials in the same condition.
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- NCT07287917 — Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07349303 — Neoadjuvant Pembrolizumab in Patients With Stage IIb/c Melanoma · Phase 2 · recruiting
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Other Universitair Ziekenhuis Brussel trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07448831 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitair Ziekenhuis Brussel
- Last refreshed: 5 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07448831.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing