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

NCT04126876 | Recruiting Phase 2

• 1 other identifier: 2018/418
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

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

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (1)

• The rate of tumor positive sentinal lymph node (SLN)

  The rate of tumor positive sentinal lymph node (SLN)

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

Secondary Outcomes (3)

• Immune response in the SLN and peripheral blood

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

• Recurrence free survival (RFS)

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

• Overall survival

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

Study Arms (2)

Tilsotolimod (IMO-2125)

EXPERIMENTAL

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: Tilsotolimod

Placebo

PLACEBO COMPARATOR

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).

Drug: Saline (0.9% sodium chloride)

Interventions

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).

Also known as: IMO-2125

Tilsotolimod (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).

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.J.M. van den Eertwegh: lead
• Idera Pharmaceuticals, Inc.: collaborator

Study Sites (1)

VU Medical Centere

Amsterdam, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

• 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: 10.1158/1078-0432.CCR-17-0944.

  PMID: 28972083 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

tilsotolimod; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Tanja de Gruijl

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

• Alfons JM van den Eertwegh

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica CL Notohardjo, MD

CONTACT

+3120 4444881; intrim@vumc.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Persons that are masked/ blinded for which medication the patient receives: participant, treating physician/ team (including the person giving the intradermal injection) and peron who collects the data.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomized Controlled Phase II Multicenter Clinical Trial

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: January 22, 2020
• Primary Completion: November 1, 2021
• Study Completion (Estimated): November 1, 2031
• Last Updated: April 15, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)