A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma - Intrim 1 study

Vrije Universiteit Medisch Centrum0 个研究点目标入组 214 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•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.

•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.
•7. Women who are pregnant or breast-feeding.

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