Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment (IMPALA)

September 9, 2019 updated by: Mologen AG

Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Krems, Austria
        • Landesklinikum Krems
      • Vienna, Austria
        • Kaiser-Franz-Josef-Spital
      • Vienna, Austria
        • Krankenhaus Hietzing
      • Vienna, Austria
        • Universitätsklinik Wien
  • Belgium
      • Aalst, Belgium, 9300
        • Onze-Lieve-Vrouwziekenhuis VZW (OLV)
      • Edegem, Belgium, 2650
        • Antwerp University Hospital
      • Leuven, Belgium
        • UZ Leuven
  • Estonia
      • Tallinn, Estonia
        • East-Tallinn Central Hospital
      • Tallinn, Estonia
        • North Estonia Medical Centre
      • Tartu, Estonia
        • University clinic Tartu
  • France
      • Besançon, France
        • Hôpital Jean Minjoz
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Brest, France, 29609
        • CHRU Brest - Hôpital Morvan
      • Créteil, France, 94010
        • Hôpital Henri Mondor
      • La Chaussée Saint Victor, France, 41260
        • Polyclinique Du Bois
      • La Roche sur Yon, France, 85925
        • Centre Hospitalier Départemental Vendée
      • Le Mans, France, 72000
        • Clinique Victor Hugo
      • Lille, France, 59037
        • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
      • Marseille, France, 13385
        • Chu Hopital de La Timone
      • Montbeliard, France
        • Centre Hospitalier Belfort-Montbeliard
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Paris, France, 75651
        • Hôpital Pitié-Salpêtrière
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou (HEGP)
      • Paris, France, 72012
        • Hôpital Antoine-Béclère
      • Paris, France, 75014
        • Groupe Hosptalier Paris Saint Joseph
      • Paris, France
        • Gustave Roussy Cancer Campus
      • Poitiers, France, 86021
        • CHU de Poitiers
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rennes Cedex, France, 35042
        • Centre Eugene Marquis
      • Saint-Gregoire, France
        • Centre Hospitalier Prive Saint-Gregoire
      • Strasbourg, France, 67000
        • Clinique Saint Anne, Strasbourg Oncologie Liberale
      • Toulouse, France, 31059
        • Hopital Rangueil
  • Germany
      • Augsburg, Germany, 86156
        • Klinikum Augsburg
      • Bad Berka, Germany
        • Zentralklinik Bad Berka GmbH
      • Bad Reichenhall, Germany
        • Internistische Schwerpunktpraxis
      • Baden Baden, Germany, 76532
        • Klinikum Mittelbaden Baden-Baden Balg
      • Baden-Baden, Germany, 76532
        • Klinikum Mittelbaden Medizinische Klinik II
      • Bayreuth, Germany, 95445
        • Klinikum Bayreuth GmbH
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
      • Berlin, Germany
        • Medizinisches Versorgungszentrum Ärzteforum Seestraße
      • Berlin, Germany
        • Ärzteforum Hennigsdorf
      • Bochum, Germany, 44791
        • St. Josef-Hospital im Katholischen Klinikum Bochum
      • Bottrop, Germany, 46236
        • Onkologie / Hämatologie
      • Bottrop, Germany, 46236
        • Überörtliche Gemeinschaftspraxis
      • Bremen, Germany
        • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
      • Dortmund, Germany
        • Gefos Dortmund MBM
      • Dresden, Germany
        • Onkozentrum Dresden/Freiberg
      • Dresden, Germany
        • Unversitätsklinikum Carl Gustav Carus
      • Essen, Germany, 45136
        • Kliniken Essen-Mitte
      • Frankfurt, Germany
        • Universitatsklinikum Frankfurt
      • Frankfurt, Germany
        • Frankfurter Diakonie Kliniken
      • Freiburg, Germany
        • Universitätsklinikum Freiburg
      • Freiburg, Germany
        • Klinik für Tumorbiologie
      • Fulda, Germany
        • Medizinisches Versorgungszentrum Osthessen GmbH
      • Gießen, Germany, 35385
        • Universitätsklinikum Gießen und Marburg, Standort Gießen
      • Goslar, Germany
        • MVZ Onkologische Kooperation Harz
      • Gütersloh, Germany
        • Onkologische Schwerpunktpraxis
      • Halle, Germany, 06120
        • Universitatsklinikum Halle (Saale)
      • Halle (Saale, Germany, 06120
        • Universitatsklinikum Halle (Saale)
      • Hamburg, Germany
        • Facharztzentrum Eppendorf
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Köln, Germany
        • Universitatsklinikum Koln
      • Leer, Germany
        • Onkologische Schwerpunktpraxis Leer-Emden
      • Leverkusen, Germany, 51375
        • Klinikum Leverkusen
      • Ludwigsburg, Germany
        • Klinikum Ludwigsburg
      • Lörrach, Germany, 79539
        • Onkologie Dreiländerdreieck
      • Lörrach, Germany, 79541
        • Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach
      • Mainz, Germany
        • Universitaetsmedizin der Johannes-Gutenberg-Universitaet
      • Mannheim, Germany
        • Klinikum Mannheim GmbH
      • Marburg, Germany
        • University Hospital Marburg
      • Mönchengladbach, Germany
        • Kliniken Maria Hilf GmbH
      • München, Germany
        • Klinikum Rechts der Isar
      • München, Germany
        • Klinikum Neuperlach
      • München, Germany
        • Klinikum Bogenhausen
      • Nürnberg, Germany
        • Klinikum Nürnberg
      • Oldenburg, Germany, 26121
        • Pius-Hospital Oldenburg
      • Oldenburg, Germany
        • Klinikum Oldenburg
      • Oldenburg, Germany
        • Sana Kliniken Ostholstein
      • Ostfildern, Germany
        • Paracelsus-Krankenhaus Ruit
      • Paderborn, Germany
        • St. Vincenz-Krankenhaus
      • Recklinghausen, Germany
        • Oncologianova GmbH
      • Riesa, Germany
        • Elblandkliniken
      • Spandau, Germany
        • Vivantes Klinikum
      • Stuttgard, Germany, 70174
        • Klinikum Stuttgart - Katharinenhospital
      • Traunstein, Germany
        • Kliniken Südostbayern
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Germany, 89081
        • Universitätsklinikum Ulm
      • Ulm, Germany
        • Universitätsklinikum Ulm
      • Wiesbaden, Germany
        • Horst Schmidt Klinik
      • Witten, Germany
        • Marienhospital
      • Wuppertal, Germany, 42283
        • HELIOS Klinikum Wuppertal Medizinische Klinik I
  • Italy
      • Candiolo, Italy
        • Candiolo Cancer Institute
      • Firenze, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Genova, Italy
        • University Hospital San Martino
      • Milano, Italy
        • Ospedale San Raffaele
      • Padova, Italy
        • Istituto Oncologico Veneto
      • Pavia, Italy
        • Policlinico San Mateo
      • Rimini, Italy, 47923
        • Ospedale Infermi di Rimini, U.O. Oncologia
      • Sassari, Italy, 7100
        • Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica
      • Udine, Italy
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Spain
      • Barcelona, Spain
        • Hospital de La Santa Creu I Sant Pau
      • Barcelona, Spain
        • Hospital Clínic
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain
        • Parc Tauli Sabadell Hospital
      • Cordoba, Spain
        • Hospital Reina Sofia
      • Hospitalet de Llobregat, Spain
        • Hospital de La Santa Creu I Sant Pau
      • La Coruna, Spain
        • Complexo Hospitalario Universitario A Coruña
      • Lleida, Spain
        • Hospital Universitario Arnau de Vilanova
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Madrid, Spain
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Malaga, Spain
        • Hospital Regional Universitario Carlos Haya
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Santander, Spain
        • Hospital Universitario 12 de Octubre
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario
      • Valencia, Spain
        • Consorcio Hospital General de Valencia
  • United Kingdom
      • Aberdeen, United Kingdom
        • Aberdeen Royal Infirmary
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
      • London, United Kingdom
        • Royal Marsden Hospital
      • Manchester, United Kingdom
        • The Christie Clinic
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust - Churchill Hospital
      • Sutton, United Kingdom
        • Royal Marsden Hospital
      • York, United Kingdom, YO31 8HE
        • York Teaching Hospitals NHS Fondation Trust, Research and Development department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • dSLIM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 36 months
Overall survival after randomization
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
Safety
Time Frame: 36 months
AEs, vital signs, ECGs, safety labs as required
36 months
Overall Response rate
Time Frame: 36 months
Complete and partial responses according RECIST 1.1 after randomization
36 months
Quality of life (QoL)
Time Frame: 36 months
QoL according EORTC questionnaires
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mologen AG

Investigators

  • Principal Investigator: David Cunningham, MD, Royal Marsden Hospital London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2014

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ANTICIPATED)

May 1, 2020

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

February 28, 2014

First Posted (ESTIMATE)

March 4, 2014

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2019

Last Update Submitted That Met QC Criteria

September 9, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MGN1703-C06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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