Clinical trial NCT04126876: A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Official title: A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Malignant Melanoma
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Idera Pharmaceuticals, Inc.
First posted: 2019-10-15
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Phase II Multicenter Clinical Trial
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: The rate of tumor positive sentinal lymph node (SLN)
timeFrame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Secondary outcomes:
measure: Immune response in the SLN and peripheral blood
timeFrame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
measure: Recurrence free survival (RFS)
timeFrame: At 5 years and 10 years after sentinel node biopsy (SNB)
measure: Overall survival
timeFrame: At 5 years and 10 years after sentinel node biopsy (SNB)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Centere
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Tanja de Gruijl
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC, location VUmc
name: Alfons JM van den Eertwegh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.