NCT02077868

Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment

Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Mologen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this this trial is to prove the efficacy and safety of MGN1703 as a maintenance therapy after first-line chemotherapeutic treatment of metastatic colorectal cancer.

Detailed description

Due to the toxicity of chemotherapeutic medications treatment breaks are common practice in the treatment of metastatic colorectal cancer. During these treatment breaks a variety of maintenance treatments are available. MGN1703 is developed not only to help the Patient to recover from chemotherapy but also to boost the patient's immune System and thus help him to effectively fight the Tumor himself. After the concept has already been proved in a previous study this Trial is conducted to further evaluate the safety and efficacy of MGN1703 Treatment.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Usual Maintenance	Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other
DRUG	MGN1703 treatment	MGN1703 will be used as single agent maintenance treatment

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-02-01
• Completion: 2020-05-01
• First posted: 2014-03-04
• Last updated: 2019-09-10

Locations

125 sites across 8 countries: Austria, Belgium, Estonia, France, Germany, Italy, Spain, United Kingdom