Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment (IMPALA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02077868|
Recruitment Status : Unknown
Verified September 2019 by Mologen AG.
Recruitment status was: Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : September 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Other: Usual Maintenance Drug: MGN1703 treatment||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||May 2020|
Control Arm A
Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
Other: Usual Maintenance
Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other
Experimental: Treatment Arm B
MGN1703 treatment as maintenance therapy
Drug: MGN1703 treatment
MGN1703 will be used as single agent maintenance treatment
Other Name: dSLIM
- Overall survival [ Time Frame: 36 months ]Overall survival after randomization
- Progression Free Survival (PFS) [ Time Frame: 36 months ]PFS1: from randomization until first PD PFS2: from start of re-introduction therapy until second PD PFS3: from start of first-line Treatment until second PD
- Safety [ Time Frame: 36 months ]AEs, vital signs, ECGs, safety labs as required
- Overall Response rate [ Time Frame: 36 months ]Complete and partial responses according RECIST 1.1 after randomization
- Quality of life (QoL) [ Time Frame: 36 months ]QoL according EORTC questionnaires
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02077868
|Principal Investigator:||David Cunningham, MD||Royal Marsden Hospital London|