The gist: The first patient has been enrolled in a new clinical trial—a research study with volunteer patients. The goal of the trial is to test whether a new drug can keep cancer from returning (recurrence) in people who were treated for metastatic colorectal cancer. MGN1703 is an immunotherapy drug, meaning that it boosts a patient’s own immune system to fight cancer.
“MOLOGEN AG has enrolled the first patient in the international IMPALA study. Primary objective of the phase III pivotal trial is to prove that a switch maintenance therapy with the cancer immunotherapy MGN1703 leads to an increased overall survival (OS) in patients with metastatic colorectal carcinoma.
“IMPALA is a randomized, international, multicenter and controlled phase III trial expected to recruit about 540 patients from more than 100 European centers in eight European countries, including the five major pharma markets. The primary endpoint is overall survival. Secondary study endpoints include progression-free survival, Quality of Life (QoL) as well as safety and tolerability.
“ We are pleased that we have already enrolled the first patient in the IMPALA trial. We are excited to learn more about the efficacy of the novel immunotherapy MGN1703,’ said Prof. David Cunningham, MD, Department of Medicine and Director of Clinical Research, Royal Marsden Hospital in London. ‘The trial aims to confirm the trend in overall survival along with very good safety and tolerability of MGN1703 as observed in the IMPACT trial.’ ”