Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Drug: MGN1703 treatmentOther: Usual Maintenance
- Registration Number
- NCT02077868
- Lead Sponsor
- Mologen AG
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 540
- Signed written informed consent
- Male or female patient 18 years or older
- Histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
- Complete or partial response, as assessed by local investigators according to RECIST 1.1, within 12-30 weeks from start of induction treatment with standard first-line chemotherapy with or without biological agents
- ECOG PS 0-1
- Haematology and biochemistry laboratory results within the limits normally expected for the patient population recovering after receiving induction treatment
- Male and female patients of childbearing potential (i.e. did not undergo surgical sterilization - hysterectomy, bilateral tubal ligation, or bilateral oophorectomy - and are not post-menopausal for at least 24 consecutive months) must use an effective method of contraception. Females of child bearing potential must have a negative serum pregnancy test
- History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
- Known brain metastases (present or treated)
- Contraindication to receiving MGN1703 as per current investigator brochure
- Known hypersensitivity to any component of the study product
- Prior allogeneic stem cell transplantation or organ transplantation
- Active or uncontrolled infections or undiagnosed febrile condition
- Severe anemia requiring repeated blood cell transfusion
- Pre-existing autoimmune or antibody-mediated diseases or immune deficiency
- Chronic systemic immune therapy or immunosuppressant medication other than steroids within the last 6 weeks; continuous systemic steroid treatment within the last 2 weeks prior to start of study treatment
- Use of systemic antibiotic therapy within the last 2 weeks prior to start of study treatment
- Inadequate pulmonary function according to the Investigator's judgment, history of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan
- HIV seropositivity or active HBV/HCV infection
- Serious concomitant disease or medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications
- Female patient who is pregnant or breast feeding
- Contraindication to receive the planned standard maintenance treatment according to applicable SmPC
- Treatment with any anti-cancer investigational drug within 12 months prior to study treatment or participation in another clinical study with other investigational drugs within 28 days prior to study treatment
- Vaccination within 1 months prior to start of study treatment
- Any medical, mental, psychological or psychiatric condition that in the opinion of the investigator would not permit the patient to complete the study or understand the patient information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Arm B MGN1703 treatment MGN1703 treatment as maintenance therapy Control Arm A Usual Maintenance Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
- Primary Outcome Measures
Name Time Method Overall survival 36 months Overall survival after randomization
- Secondary Outcome Measures
Name Time Method Progression Free Survival (PFS) 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 36 months AEs, vital signs, ECGs, safety labs as required
Overall Response rate 36 months Complete and partial responses according RECIST 1.1 after randomization
Quality of life (QoL) 36 months QoL according EORTC questionnaires
Trial Locations
- Locations (121)
Krankenhaus Hietzing
🇦🇹Vienna, Austria
Universitätsklinik Wien
🇦🇹Vienna, Austria
UZ Leuven
🇧🇪Leuven, Belgium
Kaiser-Franz-Josef-Spital
🇦🇹Vienna, Austria
Onze-Lieve-Vrouwziekenhuis VZW (OLV)
🇧🇪Aalst, Belgium
Hôpital Jean Minjoz
🇫🇷Besançon, France
North Estonia Medical Centre
🇪🇪Tallinn, Estonia
Hôpital Henri Mondor
🇫🇷Créteil, France
Centre Hospitalier Privé Saint-Grégoire
🇫🇷Saint-Gregoire, France
Centre Eugene Marquis
🇫🇷Rennes, France
Medizinisches Versorgungszentrum Ärzteforum Seestrasse
🇩🇪Berlin, Germany
Gefos Dortmund MBM
🇩🇪Dortmund, Germany
Unversitätsklinikum Carl Gustav Carus
🇩🇪Dresden, Germany
Medizinisches Versorgungszentrum Osthessen GmbH
🇩🇪Fulda, Germany
Frankfurter Diakonie Kliniken
🇩🇪Frankfurt, Germany
Universitätsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Klinik für Tumorbiologie
🇩🇪Freiburg, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Kliniken Maria Hilf GmbH
🇩🇪Mönchengladbach, Germany
Sana Kliniken Ostholstein
🇩🇪Oldenburg, Germany
St. Vincenz-Krankenhaus
🇩🇪Paderborn, Germany
Horst Schmidt Klinik
🇩🇪Wiesbaden, Germany
Marienhospital
🇩🇪Witten, Germany
Universitätsklinikum Halle (Saale)
🇩🇪Halle, Germany
Facharztzentrum Eppendorf
🇩🇪Hamburg, Germany
Onkologie Dreiländerdreieck
🇩🇪Lörrach, Germany
Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach
🇩🇪Lörrach, Germany
Klinikum Nürnberg
🇩🇪Nürnberg, Germany
Pius-Hospital Oldenburg
🇩🇪Oldenburg, Germany
Klinikum rechts der Isar
🇩🇪München, Germany
Klinikum Oldenburg
🇩🇪Oldenburg, Germany
Oncologianova GmbH
🇩🇪Recklinghausen, Germany
Paracelsus-Krankenhaus Ruit
🇩🇪Ostfildern, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
🇮🇹Udine, Italy
Landesklinikum Krems
🇦🇹Krems, Austria
Antwerp University Hospital
🇧🇪Edegem, Belgium
East-Tallinn Central Hospital
🇪🇪Tallinn, Estonia
University clinic Tartu
🇪🇪Tartu, Estonia
CHRU Brest - Hôpital Morvan
🇫🇷Brest, France
Institut Bergonié
🇫🇷Bordeaux, France
Polyclinique du Bois
🇫🇷La Chaussée Saint Victor, France
Centre Hospitalier Belfort-Montbéliard
🇫🇷Montbeliard, France
Centre Hospitalier Départemental Vendée
🇫🇷La Roche sur Yon, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Hôpital Antoine-Béclère
🇫🇷Paris, France
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
🇫🇷Lille, France
CHU Hôpital de la Timone
🇫🇷Marseille, France
Groupe Hosptalier Paris Saint Joseph
🇫🇷Paris, France
Institut Mutualiste Montsouris
🇫🇷Paris, France
Hôpital Européen Georges Pompidou (HEGP)
🇫🇷Paris, France
Hopital Pitie-Salpetriere
🇫🇷Paris, France
CHU de Poitiers
🇫🇷Poitiers, France
Clinique Saint Anne, Strasbourg Oncologie Liberale
🇫🇷Strasbourg, France
Gustave Roussy Cancer Campus
🇫🇷Paris, France
Internistische Schwerpunktpraxis
🇩🇪Bad Reichenhall, Germany
Zentralklinik Bad Berka GmbH
🇩🇪Bad Berka, Germany
Klinikum Augsburg
🇩🇪Augsburg, Germany
Hôpital Rangueil
🇫🇷Toulouse, France
Klinikum Mittelbaden Baden-Baden Balg
🇩🇪Baden Baden, Germany
Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
🇩🇪Berlin, Germany
Klinikum Bayreuth GmbH
🇩🇪Bayreuth, Germany
Klinikum Mittelbaden Medizinische Klinik II
🇩🇪Baden-Baden, Germany
Onkologie / Hämatologie
🇩🇪Bottrop, Germany
Ärzteforum Hennigsdorf
🇩🇪Berlin, Germany
Überörtliche Gemeinschaftspraxis
🇩🇪Bottrop, Germany
St. Josef-Hospital im Katholischen Klinikum Bochum
🇩🇪Bochum, Germany
DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
🇩🇪Bremen, Germany
Onkozentrum Dresden/Freiberg
🇩🇪Dresden, Germany
Kliniken Essen-Mitte
🇩🇪Essen, Germany
Universitätsklinikum Gießen und Marburg, Standort Gießen
🇩🇪Gießen, Germany
Onkologische Schwerpunktpraxis
🇩🇪Gütersloh, Germany
MVZ Onkologische Kooperation Harz
🇩🇪Goslar, Germany
Universitätsklinikum Köln
🇩🇪Köln, Germany
Onkologische Schwerpunktpraxis Leer-Emden
🇩🇪Leer, Germany
Klinikum Leverkusen
🇩🇪Leverkusen, Germany
Klinikum Ludwigsburg
🇩🇪Ludwigsburg, Germany
Universitaetsmedizin der Johannes-Gutenberg-Universitaet
🇩🇪Mainz, Germany
Klinikum Mannheim GmbH
🇩🇪Mannheim, Germany
Klinikum Neuperlach
🇩🇪München, Germany
University Hospital Marburg
🇩🇪Marburg, Germany
Klinikum Bogenhausen
🇩🇪München, Germany
Elblandkliniken
🇩🇪Riesa, Germany
Klinikum Stuttgart - Katharinenhospital
🇩🇪Stuttgard, Germany
Vivantes Klinikum
🇩🇪Spandau, Germany
HELIOS Klinikum Wuppertal Medizinische Klinik I
🇩🇪Wuppertal, Germany
Kliniken Südostbayern
🇩🇪Traunstein, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Candiolo Cancer Institute
🇮🇹Candiolo, Italy
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
University Hospital San Martino
🇮🇹Genova, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Policlinico San Mateo
🇮🇹Pavia, Italy
Istituto Oncologico Veneto
🇮🇹Padova, Italy
Ospedale Infermi di Rimini, U.O. Oncologia
🇮🇹Rimini, Italy
Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica
🇮🇹Sassari, Italy
Hospital Clinic
🇪🇸Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Hospitalet de Llobregat, Spain
Hospital Universitari Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Reina Sofía
🇪🇸Cordoba, Spain
Parc Tauli Sabadell Hospital
🇪🇸Barcelona, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Santander, Spain
Hospital Universitario Ramon y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Madrid, Spain
Hospital Regional Universitario Carlos Haya
🇪🇸Malaga, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Son Llatzer
🇪🇸Palma de Mallorca, Spain
Complejo Hospitalario Universitario
🇪🇸Santiago de Compostela, Spain
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Consorcio Hospital General de Valencia
🇪🇸Valencia, Spain
The Christie Clinic
🇬🇧Manchester, United Kingdom
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Oxford University Hospitals NHS Trust - Churchill Hospital
🇬🇧Oxford, United Kingdom
York Teaching Hospitals NHS Fondation Trust, Research and Development department
🇬🇧York, United Kingdom
Complexo Hospitalario Universitario A Coruña
🇪🇸La Coruna, Spain
Hospital Universitario Arnau de Vilanova
🇪🇸Lleida, Spain