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| Name | Class |
|---|---|
| Idera Pharmaceuticals, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response in the SLN and peripheral blood | 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. | Seven days after the intradermal injection of Tilsotolimod (IMO-2125) |
| Recurrence free survival (RFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica CL Notohardjo, MD | Contact | +3120 4444881 | intrim@vumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Tanja de Gruijl | Amsterdam UMC, location VUmc | Principal Investigator |
| Alfons JM van den Eertwegh | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VU Medical Centere | Recruiting | Amsterdam | 1081 HV | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28972083 | Background | 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. |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000723013 | tilsotolimod |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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A Randomized Controlled Phase II Multicenter Clinical Trial
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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.
|
| 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). |
|
|
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence. |
| At 5 years and 10 years after sentinel node biopsy (SNB) |
| Overall survival | The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause. | At 5 years and 10 years after sentinel node biopsy (SNB) |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017670 |
| Sodium Compounds |