drugset / Trial / NCT02203864

Dose Escalation Study to Evaluate Safety and Tolerability of an Allogeneic Tumor Vaccine BIWB 2 in Patients With Advanced Malignant Melanoma

NCT02203864 ↗

Phase 1 Completed 49 enrolled Boehringer Ingelheim
Parallel-groupOpen-labelTreatment

Summary

Evaluation of safety and tolerability of four intradermal injections given at two week intervals. In addition the efficacy of transferrinfection was determined by quantifying Interleukin 2 (IL-2), which was locally produced by the implanted, transfected allogenic melanoma cells at the injection sites. Further determination of tumor specific and clinical host responses induced or augmented by the treatment were determined.

Timeline

Start
1998-08
Primary completion
2001-02
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BIBW2 component A Vaccine 0 ug Other
Subject BIBW2 component B Vaccine 0.12 ug Other
Subject BIBW2 component B Vaccine 1.2 ug Other
Subject BIBW2 component B Vaccine 12 ug Other

Indications