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Recruiting NCT04126876

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

Phase II Interventional Malignant Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tilsotolimod, Saline (0.9% sodium chloride).
Who it may be relevant to
Registry conditions: Malignant Melanoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

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

Interventions

  • Drug 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).
  • Drug 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).

Primary outcome measures

  • The rate of tumor positive sentinal lymph node (SLN) [Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)]
Secondary outcome measures (3)
  • Immune response in the SLN and peripheral blood [Time frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)]
  • Recurrence free survival (RFS) [Time frame: At 5 years and 10 years after sentinel node biopsy (SNB)]
  • Overall survival [Time frame: At 5 years and 10 years after sentinel node biopsy (SNB)]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • VU Medical Centere — Amsterdam

Publications

  • Koster BD, van den Hout MFCM, Sluijter BJR, Molenkamp BG, Vuylsteke RJCLM, Baars A, van Leeuwen PAM, Scheper RJ, Petrousjka van den Tol M, van den Eertwegh AJM, de Gruijl TD. Local Adjuvant Treatment with Low-Dose CpG-B Offers Durable Protection against Disease Recurrence in Clinical Stage I-II Melanoma: Data from Two Randomized Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5679-5686. doi: 1 PMID 28972083

Identifiers

NCT: NCT04126876 · 2018/418

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗