LICC: L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases - a Randomized, Placebo-controlled, Multicenter, Multinational, Double Blinded Phase II Trial
This trial is designed for patients with metastatic colorectal carcinoma (CRC), who have
undergone a complete resection of their primary tumor and recent resection of their liver
metastases (R0 or R1) with curative intent. No generally accepted standard care is available
following curative-intent resection of hepatic metastases in colorectal cancer patients.
L-BLP25 is a cancer vaccine that targets MUC1, a well known tumor-associated antigen.
Recently, it has been shown that MUC1 is associated with cellular transformation as
demonstrated by tumorigenicity and can confer resistance to genotoxic agents. High levels
of MUC1 cell surface expression, reported immunosuppressive activities of its released
ectodomain, and anti-adhesive properties all contribute to the ability of the MUC1 antigen
to protect and promote tumor cell growth and survival, and make MUC1 an attractive target
for cancer immunotherapy.
Based on these results, L BLP25 may have potential as adjuvant therapy after curative
resection of hepatic metastases in colorectal cancer patients.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Comparative evaluation of recurrence-free survival time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo vaccination and saline infusion)
The primary variable of this trial is recurrence free survival (RFS) time. RFS time will be measured from the date of randomization to the date of recurrence. For subjects not known to have experienced recurrence or death at the time of analysis, the time between the date of randomization and the date of last evaluation for recurrence will be calculated and used as a censored observation in the analysis.
Carl Christoph Schimanski, MD