drugset / Trial / NCT02318901

Pembrolizumab and Monoclonal Antibody Therapy in Advanced Cancer

NCT02318901

Phase 1/2 Terminated 16 enrolled Western Regional Medical Center
Non-randomizedParallel-groupOpen-labelTreatment

Summary

There will be two phase II cohorts for pembro plus trastuzumab: one cohort will be for patients with unresectable HER2 overexpressing gastric or GEJ cancers, the other cohort will be for patients with HER2 overexpressing metastatic breast cancer (MBC). The pembro plus ado-trastuzumab emtansine phase II arm will be for patients with HER2 overexpressing MBC. There will be two phase II cohorts for pembro plus cetuximab: one cohort will be for patients with HNSCC, the other cohort will be for patients with K-ras, B-raf, N-ras wildtype metastatic CRC.

Timeline

Start
2014-10
Primary completion
2018-08
Completion
2018-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cetuximab Monoclonal antibody 250 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 2 mg/kg Intravenous
Subject Trastuzumab Monoclonal antibody 6 mg/kg Intravenous
Subject Trastuzumab emtansine Other / unclassified 3.6 mg/kg Intravenous