A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Recruiting
Phase 2
Interventional Study
Malignant Melanoma
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 214 (estimated)
- Sponsor
- A.J.M. van den Eertwegh · Other
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About This Trial
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 t…
Trial Locations
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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 c…
Contacts