NL-OMON52549
Recruiting
Phase 2
A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma - Intrim 1 study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 214
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients must be willing and able to sign the informed consent and comply
- •with the study protocol.
- •2\. Must be \>\=18 years of age.
- •3\. Histologically confirmed primary malignant melanoma cutis with a Breslow
- •tumor depth \>2\.0 mm
- •4\. WHO Performance Status \<\=1\.
- •5\. 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 Criteria
- •1\. Known hypersensitivity to any oligodeoxynucleotide.
- •2\. Active autoimmune disease requiring disease\-modifying therapy at the time of
- •3\. Pathologically confirmed loco\-regional or distant metastasis.
- •4\. Non\-skin melanoma
- •5\. 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).
- •6\. Active systemic infections requiring antibiotics.
Outcomes
Primary Outcomes
Not specified
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