NCT04126876 A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
| NCT ID | NCT04126876 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | A.J.M. van den Eertwegh |
| Condition | Malignant Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 214 participants |
| Start Date | 2020-01-22 |
| Primary Completion | 2021-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 214 participants in total. It began in 2020-01-22 with a primary completion date of 2021-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is
Eligibility 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
Contact & Investigator
Tanja de Gruijl
PRINCIPAL INVESTIGATOR
Amsterdam UMC, location VUmc
Frequently Asked Questions
Who can join the NCT04126876 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04126876 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04126876 currently recruiting?
Yes, NCT04126876 is actively recruiting participants. Contact the research team at intrim@vumc.nl for enrollment information.
Where is the NCT04126876 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04126876 clinical trial?
NCT04126876 is sponsored by A.J.M. van den Eertwegh. The principal investigator is Tanja de Gruijl at Amsterdam UMC, location VUmc. The trial plans to enroll 214 participants.
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