Melanoma Clinical Trial
Official title:
Safety and Efficacy of Intramuscular Electrotransfer of Plasmid AMEP in Patients Suffering From Advanced or Metastatic Melanoma: an Open-label Phase I/II Clinical Trial - The AIMM Study (AMEP In Metastatic Melanoma)
The objective of the present trial is:
- to determine the dose limiting toxicity (DLT), maximal tolerated dose (MTD) and
recommended phase 2 dose (RP2D) of intramuscular electrotransferred Plasmid AMEP in
patients with advanced or metastatic melanoma.
- to determine the local and general safety of intramuscular electrotransferred Plasmid
AMEP
- to evaluate the efficacy of intramuscular electrotransferred Plasmid AMEP
In this open-label, multicentre, dose escalation phase I study, successive cohorts of 3
patients suffering from advanced or metastatic melanoma will be electrotransferred
increasing doses of Plasmid AMEP into muscle. Treatment will be repeated every 28 days until
progression or limiting toxicity.
Consecutive cohorts of 3 to 6 patients will be treated with increasing doses of Plasmid AMEP
at three dose levels: 0.25 mg, 1 mg and 4 mg according to an adapted 3+3 design. There will
be no intra-patient dose escalation.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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