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

Phase 2

Recruiting

• Conditions: Malignant Melanoma
• Interventions: Drug: Saline (0.9% sodium chloride); Drug: Tilsotolimod

• Registration Number: NCT04126876
• Lead Sponsor: A.J.M. van den Eertwegh

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, 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Study Start: 2020-01-22
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-14
• Last Update Posted: 2021-04-15
• Primary Completion: 2021-11-01
• Study Completion: 2031-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 214

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Saline (0.9% sodium chloride)	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).
Tilsotolimod (IMO-2125)	Tilsotolimod	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).

Primary Outcome Measures

Name	Time	Method
The rate of tumor positive sentinal lymph node (SLN)	Seven days after the intradermal injection of Tilsotolimod (IMO-2125)	The rate of tumor positive sentinal lymph node (SLN)

Secondary Outcome Measures

Name	Time	Method
Overall survival	At 5 years and 10 years after sentinel node biopsy (SNB)	The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.
Immune response in the SLN and peripheral blood	Seven days after the intradermal injection of Tilsotolimod (IMO-2125)	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.
Recurrence free survival (RFS)	At 5 years and 10 years after sentinel node biopsy (SNB)	The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.

Trial Locations

Locations (1)

VU Medical Centere; 🇳🇱 Amsterdam, Netherlands