A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Tilsotolimod
- Conditions
- Malignant Melanoma
- Sponsor
- A.J.M. van den Eertwegh
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- The rate of tumor positive sentinal lymph node (SLN)
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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
Investigators
A.J.M. van den Eertwegh
Principal Investigator
Amsterdam UMC, location VUmc
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
Arms & Interventions
Tilsotolimod (IMO-2125)
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).
Intervention: Tilsotolimod
Placebo
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).
Intervention: Saline (0.9% sodium chloride)
Outcomes
Primary Outcomes
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
- 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))