Intradermal treatment for advanced melanoma
A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
PHASE2 · Amsterdam UMC, location VUmc · NCT04126876
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Amsterdam UMC, location VUmc (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT04126876 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with active autoimmune diseases, known hypersensitivity to oligodeoxynucleotides, or those with metastatic melanoma will not benefit from this study.
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 performed: Previous studies have shown promising results with similar immune stimulation approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Amsterdam
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Melanoma