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NCT Number: NCT04126876

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

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

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Key information

Conditions

Malignant Melanoma Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

VU Medical Centere

Amsterdam, 1081 HV, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tilsotolimod

Drug

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).

Other names: IMO-2125

Saline (0.9% sodium chloride)

Drug

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).

Other names: Placebo

Primary outcomes

  1. The rate of tumor positive sentinal lymph node (SLN)

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

    The rate of tumor positive sentinal lymph node (SLN)

Secondary outcomes

  1. Immune response in the SLN and peripheral blood

    Time frame: 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.

  2. Recurrence free survival (RFS)

    Time frame: 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.

  3. Overall survival

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica CL Notohardjo, MD

CONTACT

[email protected]

+3120 4444881

Sponsors and collaborators

Lead sponsor

A.J.M. van den Eertwegh

Other

Collaborators

  • Idera Pharmaceuticals, Inc.

Registry information

Official study title

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

Acronym: INTRIM

Important dates

Study start
2020
Primary completion
2021
Study completion
2031
First posted
Oct 15, 2019
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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