Actively Recruiting
A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Led by A.J.M. van den Eertwegh · Updated on 2021-04-15
214
Participants Needed
1
Research Sites
614 weeks
Total Duration
On this page
Sponsors
A
A.J.M. van den Eertwegh
Lead Sponsor
I
Idera Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- Scheduled to undergo a combined 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
You will not qualify if you...
- Known hypersensitivity to any oligodeoxynucleotide
- Active auto-immune disease requiring disease-modifying therapy at the time of screening
- Pathologically confirmed loco-regional or distant metastasis
- Non-skin melanoma
- Patients with another primary malignancy (some exceptions apply)
- Active systemic infections requiring antibiotics
- Women who are pregnant or breast-feeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VU Medical Centere
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
Research Team
J
Jessica CL Notohardjo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here