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

Phase 2RecruitingNCT04126876

A.J.M. van den Eertwegh214 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

214

Conditions

Malignant Melanoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The rate of tumor positive sentinal lymph node (SLN)

Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)

Secondary Outcomes

Immune response in the SLN and peripheral blood

Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood.

Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)

Recurrence free survival (RFS)

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.

Time frame: At 5 years and 10 years after sentinel node biopsy (SNB)

Overall survival

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.