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

Metastatic Colorectal Cancer Clinical Trial

— IMPALA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02077868
• Other study ID #: MGN1703-C06
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: May 2020

Study information

• Verified date: September 2019
• Source: Mologen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 540
• Est. completion date: May 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Other:
• Usual Maintenance
Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other

Drug:
• MGN1703 treatment
MGN1703 will be used as single agent maintenance treatment

Locations

Country	Name	City	State
Austria	Landesklinikum Krems	Krems
Austria	Kaiser-Franz-Josef-Spital	Vienna
Austria	Krankenhaus Hietzing	Vienna
Austria	Universitätsklinik Wien	Vienna
Belgium	Onze-Lieve-Vrouwziekenhuis VZW (OLV)	Aalst
Belgium	Antwerp University Hospital	Edegem
Belgium	UZ Leuven	Leuven
Estonia	East-Tallinn Central Hospital	Tallinn
Estonia	North Estonia Medical Centre	Tallinn
Estonia	University clinic Tartu	Tartu
France	Hôpital Jean Minjoz	Besançon
France	Institut Bergonié	Bordeaux
France	CHRU Brest - Hôpital Morvan	Brest
France	Hôpital Henri Mondor	Créteil
France	Polyclinique du Bois	La Chaussée Saint Victor
France	Centre Hospitalier Départemental Vendée	La Roche sur Yon
France	Clinique Victor Hugo	Le Mans
France	Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez	Lille
France	CHU Hôpital de la Timone	Marseille
France	Centre Hospitalier Belfort-Montbéliard	Montbeliard
France	Groupe Hosptalier Paris Saint Joseph	Paris
France	Gustave Roussy Cancer Campus	Paris
France	Hôpital Antoine-Béclère	Paris
France	Hôpital Européen Georges Pompidou (HEGP)	Paris
France	Hopital Pitie-Salpetriere	Paris
France	Institut Mutualiste Montsouris	Paris
France	CHU de Poitiers	Poitiers
France	Centre Eugene Marquis	Rennes
France	Centre Eugene Marquis	Rennes Cedex
France	Centre Hospitalier Privé Saint-Grégoire	Saint-Gregoire
France	Clinique Saint Anne, Strasbourg Oncologie Liberale	Strasbourg
France	Hôpital Rangueil	Toulouse
Germany	Klinikum Augsburg	Augsburg
Germany	Zentralklinik Bad Berka GmbH	Bad Berka
Germany	Internistische Schwerpunktpraxis	Bad Reichenhall
Germany	Klinikum Mittelbaden Baden-Baden Balg	Baden Baden
Germany	Klinikum Mittelbaden Medizinische Klinik II	Baden-Baden
Germany	Klinikum Bayreuth GmbH	Bayreuth
Germany	Ärzteforum Hennigsdorf	Berlin
Germany	Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin	Berlin
Germany	Medizinisches Versorgungszentrum Ärzteforum Seestrasse	Berlin
Germany	St. Josef-Hospital im Katholischen Klinikum Bochum	Bochum
Germany	Onkologie / Hämatologie	Bottrop
Germany	Überörtliche Gemeinschaftspraxis	Bottrop
Germany	DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH	Bremen
Germany	Gefos Dortmund MBM	Dortmund
Germany	Onkozentrum Dresden/Freiberg	Dresden
Germany	Unversitätsklinikum Carl Gustav Carus	Dresden
Germany	Kliniken Essen-Mitte	Essen
Germany	Frankfurter Diakonie Kliniken	Frankfurt
Germany	Universitätsklinikum Frankfurt	Frankfurt
Germany	Klinik für Tumorbiologie	Freiburg
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Medizinisches Versorgungszentrum Osthessen GmbH	Fulda
Germany	Universitätsklinikum Gießen und Marburg, Standort Gießen	Gießen
Germany	MVZ Onkologische Kooperation Harz	Goslar
Germany	Onkologische Schwerpunktpraxis	Gütersloh
Germany	Universitätsklinikum Halle (Saale)	Halle
Germany	Universitätsklinikum Halle (Saale)	Halle (Saale
Germany	Facharztzentrum Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Köln	Köln
Germany	Onkologische Schwerpunktpraxis Leer-Emden	Leer
Germany	Klinikum Leverkusen	Leverkusen
Germany	Onkologie Dreiländerdreieck	Lörrach
Germany	Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach	Lörrach
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	Nürnberg
Germany	Klinikum Oldenburg	Oldenburg
Germany	Pius-Hospital 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
Germany	Kliniken Südostbayern	Traunstein
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Germany	Universitätsklinikum Ulm	Ulm
Germany	Horst Schmidt Klinik	Wiesbaden
Germany	Marienhospital	Witten
Germany	HELIOS Klinikum Wuppertal Medizinische Klinik I	Wuppertal
Italy	Candiolo Cancer Institute	Candiolo
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	University Hospital San Martino	Genova
Italy	Ospedale San Raffaele	Milano
Italy	Istituto Oncologico Veneto	Padova
Italy	Policlinico San Mateo	Pavia
Italy	Ospedale Infermi di Rimini, U.O. Oncologia	Rimini
Italy	Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica	Sassari
Italy	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia	Udine
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	Cordoba
Spain	Hospital de la Santa Creu i Sant Pau	Hospitalet de Llobregat
Spain	Complexo Hospitalario Universitario A Coruña	La Coruna
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	Malaga
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
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital	Bournemouth
United Kingdom	Royal Marsden Hospital	London
United Kingdom	The Christie Clinic	Manchester
United Kingdom	Oxford University Hospitals NHS Trust - Churchill Hospital	Oxford
United Kingdom	Royal Marsden Hospital	Sutton
United Kingdom	York Teaching Hospitals NHS Fondation Trust, Research and Development department	York

Sponsors (1)

Lead Sponsor	Collaborator
Mologen AG

Countries where clinical trial is conducted

Austria,  Belgium,  Estonia,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival after randomization	36 months
Secondary	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
Secondary	Safety	AEs, vital signs, ECGs, safety labs as required	36 months
Secondary	Overall Response rate	Complete and partial responses according RECIST 1.1 after randomization	36 months
Secondary	Quality of life (QoL)	QoL according EORTC questionnaires	36 months