Clinical trial NCT02077868: Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
Official title: Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Metastatic Colorectal Cancer
Keywords: CRC
mCRC
maintenance treatment
immune modulation
colorectal cancer
immunotherapy
metastatic
Lead sponsor: Mologen AG
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Overall survival
timeFrame: 36 months
Secondary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 36 months
measure: Safety
timeFrame: 36 months
measure: Overall Response rate
timeFrame: 36 months
measure: Quality of life (QoL)
timeFrame: 36 months
Other outcomes:
Locations:
city: Krems
country: Austria
facility: Landesklinikum Krems
city: Vienna
country: Austria
facility: Kaiser-Franz-Josef-Spital
city: Vienna
country: Austria
facility: Krankenhaus Hietzing
city: Vienna
country: Austria
facility: Universitätsklinik Wien
city: Aalst
country: Belgium
facility: Onze-Lieve-Vrouwziekenhuis VZW (OLV)
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Leuven
country: Belgium
facility: UZ Leuven
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: University clinic Tartu
city: Besançon
country: France
facility: Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Brest
country: France
facility: CHRU Brest - Hôpital Morvan
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: La Chaussée Saint Victor
country: France
facility: Polyclinique du Bois
city: La Roche sur Yon
country: France
facility: Centre Hospitalier Départemental Vendée
city: Le Mans
country: France
facility: Clinique Victor Hugo
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
city: Marseille
country: France
facility: CHU Hôpital de la Timone
city: Montbeliard
country: France
facility: Centre Hospitalier Belfort-Montbéliard
city: Paris
country: France
facility: Hôpital Antoine-Béclère
city: Paris
country: France
facility: Groupe Hosptalier Paris Saint Joseph
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou (HEGP)
city: Paris
country: France
facility: Hopital Pitie-Salpetriere
city: Paris
country: France
facility: Gustave Roussy Cancer Campus
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes Cedex
country: France
facility: Centre Eugene Marquis
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Saint-Gregoire
country: France
facility: Centre Hospitalier Privé Saint-Grégoire
city: Strasbourg
country: France
facility: Clinique Saint Anne, Strasbourg Oncologie Liberale
city: Toulouse
country: France
facility: Hôpital Rangueil
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Reichenhall
country: Germany
facility: Internistische Schwerpunktpraxis
city: Baden Baden
country: Germany
facility: Klinikum Mittelbaden Baden-Baden Balg
city: Baden-Baden
country: Germany
facility: Klinikum Mittelbaden Medizinische Klinik II
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Medizinisches Versorgungszentrum Ärzteforum Seestrasse
city: Berlin
country: Germany
facility: Ärzteforum Hennigsdorf
city: Bochum
country: Germany
facility: St. Josef-Hospital im Katholischen Klinikum Bochum
city: Bottrop
country: Germany
facility: Onkologie / Hämatologie
city: Bottrop
country: Germany
facility: Überörtliche Gemeinschaftspraxis
city: Bremen
country: Germany
facility: DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
city: Dortmund
country: Germany
facility: Gefos Dortmund MBM
city: Dresden
country: Germany
facility: Onkozentrum Dresden/Freiberg
city: Dresden
country: Germany
facility: Unversitätsklinikum Carl Gustav Carus
city: Essen
country: Germany
facility: Kliniken Essen-Mitte
city: Frankfurt
country: Germany
facility: Frankfurter Diakonie Kliniken
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Klinik für Tumorbiologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Fulda
country: Germany
facility: Medizinisches Versorgungszentrum Osthessen GmbH
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg, Standort Gießen
city: Goslar
country: Germany
facility: MVZ Onkologische Kooperation Harz
city: Gütersloh
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Halle (Saale
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Köln
country: Germany
facility: Universitätsklinikum Köln
city: Leer
country: Germany
facility: Onkologische Schwerpunktpraxis Leer-Emden
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
city: Lörrach
country: Germany
facility: Onkologie Dreiländerdreieck
city: Lörrach
country: Germany
facility: Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach
city: Mainz
country: Germany
facility: Universitaetsmedizin der Johannes-Gutenberg-Universitaet
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH
city: Marburg
country: Germany
facility: University Hospital Marburg
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
city: München
country: Germany
facility: Klinikum Bogenhausen
city: München
country: Germany
facility: Klinikum Neuperlach
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oldenburg
country: Germany
facility: Pius-Hospital Oldenburg
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Oldenburg
country: Germany
facility: Sana Kliniken Ostholstein
city: Ostfildern
country: Germany
facility: Paracelsus-Krankenhaus Ruit
city: Paderborn
country: Germany
facility: St. Vincenz-Krankenhaus
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Riesa
country: Germany
facility: Elblandkliniken
city: Spandau
country: Germany
facility: Vivantes Klinikum
city: Stuttgard
country: Germany
facility: Klinikum Stuttgart - Katharinenhospital
city: Traunstein
country: Germany
facility: Kliniken Südostbayern
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wiesbaden
country: Germany
facility: Horst Schmidt Klinik
city: Witten
country: Germany
facility: Marienhospital
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal Medizinische Klinik I
city: Candiolo
country: Italy
facility: Candiolo Cancer Institute
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Genova
country: Italy
facility: University Hospital San Martino
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Policlinico San Mateo
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini, U.O. Oncologia
city: Sassari
country: Italy
facility: Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica
city: Udine
country: Italy
facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Parc Tauli Sabadell Hospital
city: Cordoba
country: Spain
facility: Hospital Reina Sofía
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: La Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro - Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Santander
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario
city: Valencia
country: Spain
facility: Consorcio Hospital General de Valencia
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: The Christie Clinic
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust - Churchill Hospital
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital
city: York
country: United Kingdom
facility: York Teaching Hospitals NHS Fondation Trust, Research and Development department
Study officials:
affiliation: Royal Marsden Hospital London
name: David Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
References: