Malignant Melanoma
Conditions
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
Interventions
DRUGTilsotolimod
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).
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).
Sponsors
Idera Pharmaceuticals, Inc.
A.J.M. van den Eertwegh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
A Randomized Controlled Phase II Multicenter Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Netherlands
Contacts
Primary ContactJessica CL Notohardjo, MD
Outcome results
None listed