Malignant Melanoma Clinical Trial
Official title:
Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage III and IV Melanoma Patients: a Phase II Randomized Trial (ACDC Adjuvant Trial)
This phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.
This study will be a randomized phase II trial (1:1 allocation ratio) in resected stage
III/IV melanoma patients. The randomization list will be stratified by stage (III and IV
M1a-b and IVM1c), and time from primitive tumor to first metastasis (≤ 2 years versus > 2
years). Five randomization lists will be defined, one for each stratum.
On the basis of literature, the investigators assume a median relapse-free survival of 7.0
months for the standard group. With a two-sided tailed alpha of 0.10 and power of 80%,
assuming a median relapse-free survival of 11.7 months in the experimental arm (hazard ratio
0.60), it will be necessary to recruit 60 patients per arm over a period of 24 months and to
have a subsequent 12 months of follow-up. In the context of data monitoring board activities,
an interim analysis for futility, according to the Bayesian approach, will be performed at 18
months in order to control the safety.
Primary endpoints will be relapse free survival. Secondary end points will be OS, In vivo and
in vitro immunomonitoring. Immunologic efficacy will be measured by best Delayed Type
Hypersensitivity score (reactivity to lysate or KLH) obtained after at least 4 vaccine doses,
alone or combined with Interferon-g ELISPOT analysis of tumor antigen-specific circulating
effectors obtained after a minimum of 4 vaccine doses, both compared with prevaccine samples.
In vivo monitoring will focus on functional phenotyping of circulating immune
effectors/regulators, functional characterization of circulating tumor antigen-specific
immune effectors and regulators, and identification of serum markers that are predictive of
response.
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