Status:
RECRUITING
A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Lead Sponsor:
A.J.M. van den Eertwegh
Collaborating Sponsors:
Idera Pharmaceuticals, Inc.
Conditions:
Malignant Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04126876
Start Date
January 22 2020
End Date
November 1 2031
Last Update
April 15 2021
Active Locations (1)
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1
VU Medical Centere
Amsterdam, Netherlands, 1081 HV