NCT04126876RecruitingPhase 2
A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma
Source: ClinicalTrials.gov · Last updated 15 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 10 Oct 2019
- Start date
- 22 Jan 2020
- Primary completion date
- 1 Nov 2021
- Lead sponsor
- A.J.M. van den Eertwegh
- Diseases
- Melanoma
- NCT number
- NCT04126876
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 214
- From 22 Jan 2020 to the primary completion date, 1 Nov 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Known hypersensitivity to any oligodeoxynucleotide
- Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
- Patients with another primary malignancy (some exceptions)
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VU Medical Centere Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.