Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
IMPALA
Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment
1 other identifier
interventional
540
7 countries
105
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2014
Longer than P75 for phase_3
105 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2014
CompletedFirst Posted
Study publicly available on registry
March 4, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedSeptember 10, 2019
September 1, 2019
4.4 years
February 28, 2014
September 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
Overall survival after randomization
36 months
Secondary Outcomes (4)
Progression Free Survival (PFS)
36 months
Safety
36 months
Overall Response rate
36 months
Quality of life (QoL)
36 months
Study Arms (2)
Control Arm A
OTHERPatients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
Treatment Arm B
EXPERIMENTALMGN1703 treatment as maintenance therapy
Interventions
Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other
MGN1703 will be used as single agent maintenance treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mologen AGlead
Study Sites (125)
Landesklinikum Krems
Krems, Austria
Kaiser-Franz-Josef-Spital
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
Padua, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Cunningham, MD
Royal Marsden Hospital London
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2014
First Posted
March 4, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2019
Study Completion
May 1, 2020
Last Updated
September 10, 2019
Record last verified: 2019-09