Melanoma Clinical Trial
This phase I study plan is divided in the following four phases:
- Eligibility Screen Phase (week -4 to -1): Following written informed consent patients
with metastatic melanoma (AJCC stage III/IV with unresectable disease) will undergo an
eligibility screen (incl. blood analysis and PET/CT-scan).
- TriMix-DC Vaccine Manufacturing Phase (week I to IV): eligible patients will undergo a
leucapheresis (15 liter of venous blood) for the preparation of autologous TriMix-DC
vaccine. Vaccine preparations will be manufactured and quality-controlled (during an
interval of 4 weeks following the leucapheresis) and released for patient
administration if the TriMix-DC preparation fulfills the predefined quality
requirements.
- TriMix-DC Vaccine Administration Phase (Week 1 to 24): 4 weeks after the leucapheresis
patients will initiate therapeutic vaccination with the TriMix-DC vaccine by IV and ID
administration. The vaccines will be administered at 4 different visits that will be
separated with an interval of 2 weeks. At each vaccination a total of 12.106 DC per
antigen will be administered.
- Patients will be allocated to three different cohorts:
- The first cohort will receive 10% of TriMix-DC by iv and 90% by id injection.
- The second cohort 25% by iv and 75% by id injection.
- The third cohort 50% by iv and 50% by id injection.
- During the week following the administration of the fourth vaccine (= week 8), a
DTH-test and punch biopsy of the injection site will be performed as well as a second
leucapheresis (for the purpose of immuno-monitoring) and tumor evaluation (by PET-CT).
- A fifth vaccine will be administered and a repeat tumor staging performed in week 16 (=
8w after the fourth vaccine).
- End of study visit: Patients will perform an "end of study visit" 8 weeks after the
fifth vaccine (= week 24) as well as a new tumor evaluation (PET/CT).
- Follow-up Phase: survival data will be obtained until 3 years after the initiation of
vaccine therapy or the time of death.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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