2023-509461-20-00Active, not recruitingPhase 2
A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma (Intrim 1 study)
A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in clinical cT3-4N0M0 Melanoma (Intrim 1 study)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 6 Dec 2024
Brief summary (registry, in English)
To investigate if local administration of IMO-2125 results in lower rates of tumor positive SLN in patients with pT3-4 cN0M0 melanoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 22 Jan 2020
- Lead sponsor
- Amsterdam UMC
- Diseases
- Melanoma
- EU CT number
- 2023-509461-20-00
- EudraCT number
- 2018-001992-19
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 214
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pathologically confirmed loco-regional or distant metastasis.
- Non-skin melanoma
- Women who are pregnant or breast-feeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Noordwest Ziekenhuisgroep Stichting | Alkmaar | Netherlands | Active, not recruiting |
| Amsterdam UMC Stichting | Amsterdam | Netherlands | Active, not recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting | Amsterdam | Netherlands | Active, not recruiting |
| Spaarne Gasthuis Stichting | Hoofddorp | Netherlands | Active, not recruiting |
| Diakonessenhuis Stichting | Utrecht | Netherlands | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.