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

A.J.M. van den Eertwegh

Status and phase: Enrolling; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: Tilsotolimod; Drug: Saline (0.9% sodium chloride)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04126876

2018/418

Details and patient eligibility

About

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

Enrollment: 214 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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214 participants in 2 patient groups, including a placebo group

Tilsotolimod (IMO-2125)

Experimental group

Description:

Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).

Treatment:

Drug: Tilsotolimod

Placebo

Placebo Comparator group

Description:

Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).

Treatment:

Drug: Saline (0.9% sodium chloride)