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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm A | Other | Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision |
|
| Treatment Arm B | Experimental | MGN1703 treatment as maintenance therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Maintenance | Other | Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival after randomization | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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 | 36 months |
| Safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Cunningham, MD | Royal Marsden Hospital London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Landesklinikum Krems | Krems | Austria | ||||
| Kaiser-Franz-Josef-Spital |
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| MGN1703 treatment | Drug | MGN1703 will be used as single agent maintenance treatment |
|
|
AEs, vital signs, ECGs, safety labs as required
| 36 months |
| Overall Response rate | Complete and partial responses according RECIST 1.1 after randomization | 36 months |
| Quality of life (QoL) | QoL according EORTC questionnaires | 36 months |
| Vienna |
| Austria |
| Krankenhaus Hietzing | Vienna | Austria |
| Universitätsklinik Wien | Vienna | Austria |
| Onze-Lieve-Vrouwziekenhuis VZW (OLV) | Aalst | 9300 | Belgium |
| Antwerp University Hospital | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | Belgium |
| East-Tallinn Central Hospital | Tallinn | Estonia |
| North Estonia Medical Centre | Tallinn | Estonia |
| University clinic Tartu | Tartu | Estonia |
| Hôpital Jean Minjoz | Besançon | France |
| Institut Bergonié | Bordeaux | 33076 | France |
| CHRU Brest - Hôpital Morvan | Brest | 29609 | France |
| Hôpital Henri Mondor | Créteil | 94010 | France |
| Polyclinique du Bois | La Chaussée-Saint-Victor | 41260 | France |
| Centre Hospitalier Départemental Vendée | La Roche-sur-Yon | 85925 | France |
| Clinique Victor Hugo | Le Mans | 72000 | France |
| Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | 59037 | France |
| CHU Hôpital de la Timone | Marseille | 13385 | France |
| Centre Hospitalier Belfort-Montbéliard | Montbéliard | France |
| Hôpital Antoine-Béclère | Paris | 72012 | France |
| Groupe Hosptalier Paris Saint Joseph | Paris | 75014 | France |
| Institut Mutualiste Montsouris | Paris | 75014 | France |
| Hôpital Européen Georges Pompidou (HEGP) | Paris | 75015 | France |
| Hopital Pitie-Salpetriere | Paris | 75651 | France |
| Gustave Roussy Cancer Campus | Paris | France |
| CHU de Poitiers | Poitiers | 86021 | France |
| Centre Eugene Marquis | Rennes | 35042 | France |
| Centre Hospitalier Privé Saint-Grégoire | Saint-Grégoire | France |
| Clinique Saint Anne, Strasbourg Oncologie Liberale | Strasbourg | 67000 | France |
| Hôpital Rangueil | Toulouse | 31059 | France |
| Klinikum Augsburg | Augsburg | 86156 | Germany |
| Zentralklinik Bad Berka GmbH | Bad Berka | Germany |
| Internistische Schwerpunktpraxis | Bad Reichenhall | Germany |
| Klinikum Mittelbaden Baden-Baden Balg | Baden-Baden | 76532 | Germany |
| Klinikum Mittelbaden Medizinische Klinik II | Baden-Baden | 76532 | Germany |
| Klinikum Bayreuth GmbH | Bayreuth | 95445 | Germany |
| Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin | Berlin | 12203 | Germany |
| Medizinisches Versorgungszentrum Ärzteforum Seestrasse | Berlin | Germany |
| Ärzteforum Hennigsdorf | Berlin | Germany |
| St. Josef-Hospital im Katholischen Klinikum Bochum | Bochum | 44791 | Germany |
| Onkologie / Hämatologie | Bottrop | 46236 | Germany |
| Überörtliche Gemeinschaftspraxis | Bottrop | 46236 | Germany |
| DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH | Bremen | Germany |
| Universitätsklinikum Köln | Cologne | Germany |
| Gefos Dortmund MBM | Dortmund | Germany |
| Onkozentrum Dresden/Freiberg | Dresden | Germany |
| Unversitätsklinikum Carl Gustav Carus | Dresden | Germany |
| Kliniken Essen-Mitte | Essen | 45136 | Germany |
| Frankfurter Diakonie Kliniken | Frankfurt | Germany |
| Universitätsklinikum Frankfurt | Frankfurt | Germany |
| Klinik für Tumorbiologie | Freiburg im Breisgau | Germany |
| Universitätsklinikum Freiburg | Freiburg im Breisgau | Germany |
| Medizinisches Versorgungszentrum Osthessen GmbH | Fulda | Germany |
| Universitätsklinikum Gießen und Marburg, Standort Gießen | Giessen | 35385 | Germany |
| MVZ Onkologische Kooperation Harz | Goslar | Germany |
| Onkologische Schwerpunktpraxis | Gütersloh | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06120 | Germany |
| Facharztzentrum Eppendorf | Hamburg | Germany |
| Medizinische Hochschule Hannover | Hanover | Germany |
| Onkologische Schwerpunktpraxis Leer-Emden | Leer | Germany |
| Klinikum Leverkusen | Leverkusen | 51375 | Germany |
| Onkologie Dreiländerdreieck | Loerrach | 79539 | Germany |
| Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach | Loerrach | 79541 | Germany |
| Klinikum Ludwigsburg | Ludwigsburg | Germany |
| Universitaetsmedizin der Johannes-Gutenberg-Universitaet | Mainz | Germany |
| Klinikum Mannheim GmbH | Mannheim | Germany |
| University Hospital Marburg | Marburg | Germany |
| Kliniken Maria Hilf GmbH | Mönchengladbach | Germany |
| Klinikum Bogenhausen | München | Germany |
| Klinikum Neuperlach | München | Germany |
| Klinikum rechts der Isar | München | Germany |
| Klinikum Nürnberg | Nuremberg | Germany |
| Pius-Hospital Oldenburg | Oldenburg | 26121 | Germany |
| Klinikum Oldenburg | Oldenburg | Germany |
| Sana Kliniken Ostholstein | Oldenburg | Germany |
| Paracelsus-Krankenhaus Ruit | Ostfildern | Germany |
| St. Vincenz-Krankenhaus | Paderborn | Germany |
| Oncologianova GmbH | Recklinghausen | Germany |
| Elblandkliniken | Riesa | Germany |
| Vivantes Klinikum | Spandau | Germany |
| Klinikum Stuttgart - Katharinenhospital | Stuttgard | 70174 | Germany |
| Kliniken Südostbayern | Traunstein | Germany |
| Universitätsklinikum Tübingen | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Universitätsklinikum Ulm | Ulm | Germany |
| Horst Schmidt Klinik | Wiesbaden | Germany |
| Marienhospital | Witten | Germany |
| HELIOS Klinikum Wuppertal Medizinische Klinik I | Wuppertal | 42283 | Germany |
| Candiolo Cancer Institute | Candiolo | Italy |
| Azienda Ospedaliero-Universitaria Careggi | Florence | Italy |
| University Hospital San Martino | Genova | Italy |
| Ospedale San Raffaele | Milan | Italy |
| Istituto Oncologico Veneto | Padova | Italy |
| Policlinico San Mateo | Pavia | Italy |
| Ospedale Infermi di Rimini, U.O. Oncologia | Rimini | 47923 | Italy |
| Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica | Sassari | 7100 | Italy |
| Azienda Ospedaliero-Universitaria Santa Maria della Misericordia | Udine | Italy |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Spain |
| Hospital Clinic | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Universitari Germans Trias i Pujol | Barcelona | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | Spain |
| Parc Tauli Sabadell Hospital | Barcelona | Spain |
| Hospital Reina Sofía | Córdoba | Spain |
| Hospital de la Santa Creu i Sant Pau | L'Hospitalet de Llobregat | Spain |
| Hospital Universitario Arnau de Vilanova | Lleida | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Spain |
| Hospital Universitario 12 de Octubre | Santander | Spain |
| Complejo Hospitalario Universitario | Santiago de Compostela | Spain |
| Consorcio Hospital General de Valencia | Valencia | Spain |
| Aberdeen Royal Infirmary | Aberdeen | United Kingdom |
| The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital | Bournemouth | BH7 7DW | United Kingdom |
| Royal Marsden Hospital | London | United Kingdom |
| The Christie Clinic | Manchester | United Kingdom |
| Oxford University Hospitals NHS Trust - Churchill Hospital | Oxford | OX3 7LE | United Kingdom |
| Royal Marsden Hospital | Sutton | United Kingdom |
| York Teaching Hospitals NHS Fondation Trust, Research and Development department | York | YO31 8HE | United Kingdom |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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