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

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Usual Maintenance
MGN1703 treatment
Sponsored by
Mologen AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring CRC, mCRC, maintenance treatment, immune modulation, colorectal cancer, immunotherapy, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Landesklinikum Krems
  • Kaiser-Franz-Josef-Spital
  • Krankenhaus Hietzing
  • Universitätsklinik Wien
  • Onze-Lieve-Vrouwziekenhuis VZW (OLV)
  • Antwerp University Hospital
  • UZ Leuven
  • East-Tallinn Central Hospital
  • North Estonia Medical Centre
  • University clinic Tartu
  • Hôpital Jean Minjoz
  • Institut Bergonié
  • CHRU Brest - Hôpital Morvan
  • Hôpital Henri Mondor
  • Polyclinique du Bois
  • Centre Hospitalier Départemental Vendée
  • Clinique Victor Hugo
  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez
  • CHU Hôpital de la Timone
  • Centre Hospitalier Belfort-Montbéliard
  • Hôpital Antoine-Béclère
  • Groupe Hosptalier Paris Saint Joseph
  • Institut Mutualiste Montsouris
  • Hôpital Européen Georges Pompidou (HEGP)
  • Hopital Pitie-Salpetriere
  • Gustave Roussy Cancer Campus
  • CHU de Poitiers
  • Centre Eugene Marquis
  • Centre Eugene Marquis
  • Centre Hospitalier Privé Saint-Grégoire
  • Clinique Saint Anne, Strasbourg Oncologie Liberale
  • Hôpital Rangueil
  • Klinikum Augsburg
  • Zentralklinik Bad Berka GmbH
  • Internistische Schwerpunktpraxis
  • Klinikum Mittelbaden Baden-Baden Balg
  • Klinikum Mittelbaden Medizinische Klinik II
  • Klinikum Bayreuth GmbH
  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin
  • Medizinisches Versorgungszentrum Ärzteforum Seestrasse
  • Ärzteforum Hennigsdorf
  • St. Josef-Hospital im Katholischen Klinikum Bochum
  • Onkologie / Hämatologie
  • Überörtliche Gemeinschaftspraxis
  • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH
  • Gefos Dortmund MBM
  • Onkozentrum Dresden/Freiberg
  • Unversitätsklinikum Carl Gustav Carus
  • Kliniken Essen-Mitte
  • Frankfurter Diakonie Kliniken
  • Universitätsklinikum Frankfurt
  • Klinik für Tumorbiologie
  • Universitätsklinikum Freiburg
  • Medizinisches Versorgungszentrum Osthessen GmbH
  • Universitätsklinikum Gießen und Marburg, Standort Gießen
  • MVZ Onkologische Kooperation Harz
  • Onkologische Schwerpunktpraxis
  • Universitätsklinikum Halle (Saale)
  • Universitätsklinikum Halle (Saale)
  • Facharztzentrum Eppendorf
  • Medizinische Hochschule Hannover
  • Universitätsklinikum Köln
  • Onkologische Schwerpunktpraxis Leer-Emden
  • Klinikum Leverkusen
  • Klinikum Ludwigsburg
  • Onkologie Dreiländerdreieck
  • Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach
  • Universitaetsmedizin der Johannes-Gutenberg-Universitaet
  • Klinikum Mannheim GmbH
  • University Hospital Marburg
  • Kliniken Maria Hilf GmbH
  • Klinikum Bogenhausen
  • Klinikum Neuperlach
  • Klinikum rechts der Isar
  • Klinikum Nürnberg
  • Pius-Hospital Oldenburg
  • Klinikum Oldenburg
  • Sana Kliniken Ostholstein
  • Paracelsus-Krankenhaus Ruit
  • St. Vincenz-Krankenhaus
  • Oncologianova GmbH
  • Elblandkliniken
  • Vivantes Klinikum
  • Klinikum Stuttgart - Katharinenhospital
  • Kliniken Südostbayern
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm
  • Universitätsklinikum Ulm
  • Horst Schmidt Klinik
  • Marienhospital
  • HELIOS Klinikum Wuppertal Medizinische Klinik I
  • Candiolo Cancer Institute
  • Azienda Ospedaliero-Universitaria Careggi
  • University Hospital San Martino
  • Ospedale San Raffaele
  • Istituto Oncologico Veneto
  • Policlinico San Mateo
  • Ospedale Infermi di Rimini, U.O. Oncologia
  • Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica
  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia
  • Hospital Clinic
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Vall d'Hebron
  • Parc Tauli Sabadell Hospital
  • Hospital Reina Sofía
  • Hospital de la Santa Creu i Sant Pau
  • Complexo Hospitalario Universitario A Coruña
  • Hospital Universitario Arnau de Vilanova
  • Hospital Clínico San Carlos
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario Puerta de Hierro - Majadahonda
  • Hospital Universitario Ramon y Cajal
  • Hospital Regional Universitario Carlos Haya
  • Hospital Universitario Central de Asturias
  • Hospital Son Llatzer
  • Hospital Universitario 12 de Octubre
  • Complejo Hospitalario Universitario
  • Consorcio Hospital General de Valencia
  • Aberdeen Royal Infirmary
  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital
  • Royal Marsden Hospital
  • The Christie Clinic
  • Oxford University Hospitals NHS Trust - Churchill Hospital
  • Royal Marsden Hospital
  • York Teaching Hospitals NHS Fondation Trust, Research and Development department

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Arm A

Treatment Arm B

Arm Description

Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision

MGN1703 treatment as maintenance therapy

Outcomes

Primary Outcome Measures

Overall survival
Overall survival after randomization

Secondary Outcome Measures

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
Safety
AEs, vital signs, ECGs, safety labs as required
Overall Response rate
Complete and partial responses according RECIST 1.1 after randomization
Quality of life (QoL)
QoL according EORTC questionnaires

Full Information

First Posted
February 28, 2014
Last Updated
September 9, 2019
Sponsor
Mologen AG
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1. Study Identification

Unique Protocol Identification Number
NCT02077868
Brief Title
Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment
Acronym
IMPALA
Official Title
Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mologen AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
CRC, mCRC, maintenance treatment, immune modulation, colorectal cancer, immunotherapy, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
540 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm A
Arm Type
Other
Arm Description
Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
Arm Title
Treatment Arm B
Arm Type
Experimental
Arm Description
MGN1703 treatment as maintenance therapy
Intervention Type
Other
Intervention Name(s)
Usual Maintenance
Intervention Description
Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other
Intervention Type
Drug
Intervention Name(s)
MGN1703 treatment
Other Intervention Name(s)
dSLIM
Intervention Description
MGN1703 will be used as single agent maintenance treatment
Primary Outcome Measure Information:
Title
Overall survival
Description
Overall survival after randomization
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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
Time Frame
36 months
Title
Safety
Description
AEs, vital signs, ECGs, safety labs as required
Time Frame
36 months
Title
Overall Response rate
Description
Complete and partial responses according RECIST 1.1 after randomization
Time Frame
36 months
Title
Quality of life (QoL)
Description
QoL according EORTC questionnaires
Time Frame
36 months

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://www.mologen.com/en.html
Description
Sponsor Homepage

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

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