Melanoma Melanoom Early-stage melanoma Vroeg stadium melanoom
Conditions
Interventions
In the treatment arm, patients will be intradermally injected with 8 mg IMO-2125, in 1 mL saline (0.9% sodium chloride) one week prior to sentinel node biopsy (SNB). In the placebo control arm, patie
Sponsors
VU University medical center
Eligibility
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 ≤1. 5. Women of childbearing potential and fertile men must agree to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration.
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 |
|---|---|
| The rate of tumor positive sentinel lymph nodes (SLN) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood. 2) RFS 3) OS | — |
Contacts
Public ContactBas Koster
Outcome results
None listed