A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma

Phase

Condition

Melanoma

Malignant Melanoma

Treatment

N/A

Clinical Study ID

NCT04126876

2018/418

Ages > 18
All Genders

Study 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

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 daysafter the IMO-2125 administration
Written informed consent

Exclusion

Exclusion Criteria:

Known hypersensitivity to any oligodeoxynucleotide
Active auto-immune disease requiring disease-modifying therapy at the tumr ofscreening
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

Study Design

January 22, 2020

November 01, 2031

Connect with a study center

VU Medical Centere
Amsterdam, 1081 HV
Netherlands
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.