Overview

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

Status:
Recruiting
Trial end date:
2031-11-01
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
A.J.M. van den Eertwegh
Collaborator:
Idera Pharmaceuticals, Inc.
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