Melanoma skin cancer
Conditions
Interventions
Seven days before SNB, patients will receive an intradermal injection, directly
adjacent to the excision site of the primary tumor, of 8mg IMO-2125 dissolved
in 1 mL saline (0.9% sodium chloride) (n
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion 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
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to any oligodeoxynucleotide. 2. Active autoimmune disease requiring disease-modifying therapy at the time of screening. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLN tumor status 7 days after injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Loco-regional and systemic immune profile with emphasis on recruitment and/or activation in the SLN of dendritic cell (DC), effector-T cell and Treg subsets, and melanoma antigen-specific T cell responses in peripheral blood. RFS and OS at 18 months, 24 months and 36 months after treatment. | — |
Countries
Netherlands
Outcome results
None listed