A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma (Intrim 1 study)
Key facts
- Where
- Alkmaar, Amsterdam, Hoofddorp és Utrecht, HollandiaSee the 5 sites
- Phase
- 2. fázis
Where in Hollandia
- Noordwest Ziekenhuisgroep StichtingAlkmaar, HollandiaNo longer taking part
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis StichtingAmsterdam, HollandiaNo longer taking part
- Spaarne Gasthuis StichtingHoofddorp, HollandiaNo longer taking part
- Diakonessenhuis StichtingUtrecht, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC
- Trial code
- EU 2023-509461-20-00
- Record updated
- 2024. december 6.
- Original description
To investigate if local administration of IMO-2125 results in lower rates of tumor positive SLN in patients with pT3-4 cN0M0 melanoma.Read full original descriptionShow less
A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in clinical cT3-4N0M0 Melanoma (Intrim 1 study)
To investigate if local administration of IMO-2125 results in lower rates of tumor positive SLN in patients with pT3-4 cN0M0 melanoma.
Inclusion: Patients must be willing and able to sign the informed consent and comply with the study protocol; Must be ≥18 years of age; WHO Performance Status ≤1; Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm; Women of childbearing potential (WOCBP) and fertile men must agree to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration.
Exclusion: Known hypersensitivity to any oligodeoxynucleotide; Active autoimmune disease requiring disease-modifying therapy at the time of screening; Patients with another primary malignancy that has not been in remission for at least 3 years with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic); Active systemic infections requiring antibiotics; Pathologically confirmed loco-regional or distant metastasis; Non-skin melanoma; Women who are pregnant or breast-feeding.