Intradermal treatment for advanced melanoma
Official title: A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
Run by Amsterdam UMC, location VUmc · NCT04126876 · Data updated 2026-11-12
This study is testing a new immune booster called IMO-2125 to see if it helps people with advanced melanoma feel better after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 214 (estimated) |
| Sponsor | Amsterdam UMC, location VUmc Academic / other |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | January 22, 2020 |
| Main results expected | November 1, 2021 |
| Study ends | November 1, 2031 |
| Registry record updated | April 15, 2021 |
| Trial ID | NCT04126876 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with histologically confirmed primary malignant melanoma and a Breslow tumor depth greater than 2.0 mm.
✕Probably not a fit
Patients with active autoimmune diseases, known hypersensitivity to oligodeoxynucleotides, or those with metastatic melanoma will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II trial investigates the effectiveness of IMO-2125, a next-generation immune stimulant, in patients with pathological tumor stage T3-4 cN0M0 melanoma who are scheduled for re-excision and sentinel lymph node biopsy. The study aims to evaluate the drug's ability to induce immune responses that could improve patient outcomes after surgical excision of the primary melanoma. Participants will receive intradermal injections of IMO-2125 or saline at the tumor site to assess its clinical activity and safety.
Why it matters
Potential benefit: If successful, this treatment could provide a new adjuvant therapy option to improve survival rates in melanoma patients after surgery.
How similar studies have gone: Previous studies have shown promising results with similar immune stimulation approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth \>2.0 mm * Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB) * World Health Organization (WHO) Performance Status ≤1 * Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration * Written informed consent Exclusion Criteria: * Known hypersensitivity to any oligodeoxynucleotide * Active auto-immune disease requiring disease-modifying therapy at the tumr of screening * Pathologically confirmed loco-regional or distant metastasis * Non-skin melanoma * Patients with another primary malignancy (some exceptions) * Active systemic infections requiring antibiotics * Women who are pregnant or breast-feeding
Where it's running
-
VU Medical Centere
Amsterdam, Netherlands Recruiting
Study contacts
- Principal investigator: Tanja de Gruijl — Amsterdam UMC, location VUmc
- Study coordinator: Jessica CL Notohardjo, MD
- Email: intrim@vumc.nl
- Phone: +3120 4444881
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.