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Metastatic Colorectal CancerPhase 3IMPALANCT02077868

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

A Phase 3 study testing Usual Maintenance and MGN1703 treatment in people with Metastatic Colorectal Cancer, run by Mologen AG at 125 sites in 8 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Usual Maintenance and MGN1703 treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
540 participants
Where
125 sitesin 8 countries
Study dates
Sep 2014to May 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

125 sites in 8 countries.

125 sites in 8 countries

Germany58 sites

  • Klinikum Augsburg

    Augsburg, 86156

  • Zentralklinik Bad Berka GmbH

    Bad Berka

  • Internistische Schwerpunktpraxis

    Bad Reichenhall

  • Klinikum Mittelbaden Baden-Baden Balg

    Baden-Baden, 76532

  • Klinikum Mittelbaden Medizinische Klinik II

    Baden-Baden, 76532

  • Klinikum Bayreuth GmbH

    Bayreuth, 95445

  • Charité - Universitätsmedizin Berlin - Campus Benjamin Franklin

    Berlin, 12203

  • Medizinisches Versorgungszentrum Ärzteforum Seestrasse

    Berlin

  • Ärzteforum Hennigsdorf

    Berlin

  • St. Josef-Hospital im Katholischen Klinikum Bochum

    Bochum, 44791

  • Onkologie / Hämatologie

    Bottrop, 46236

  • Überörtliche Gemeinschaftspraxis

    Bottrop, 46236

  • DIAKO Ev. Diakonie-Krankenhaus gemeinnützige GmbH

    Bremen

  • Universitätsklinikum Köln

    Cologne

  • Gefos Dortmund MBM

    Dortmund

  • Onkozentrum Dresden/Freiberg

    Dresden

  • Unversitätsklinikum Carl Gustav Carus

    Dresden

  • Kliniken Essen-Mitte

    Essen, 45136

  • Frankfurter Diakonie Kliniken

    Frankfurt

  • Universitätsklinikum Frankfurt

    Frankfurt

  • Klinik für Tumorbiologie

    Freiburg im Breisgau

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau

  • Medizinisches Versorgungszentrum Osthessen GmbH

    Fulda

  • Universitätsklinikum Gießen und Marburg, Standort Gießen

    Giessen, 35385

  • MVZ Onkologische Kooperation Harz

    Goslar

  • Onkologische Schwerpunktpraxis

    Gütersloh

  • Universitätsklinikum Halle (Saale)

    Halle, 06120

  • Facharztzentrum Eppendorf

    Hamburg

  • Medizinische Hochschule Hannover

    Hanover

  • Onkologische Schwerpunktpraxis Leer-Emden

    Leer

  • Klinikum Leverkusen

    Leverkusen, 51375

  • Onkologie Dreiländerdreieck

    Loerrach, 79539

  • Onkologie Dreiländereck - Onkologische Schwerpunktpraxis Lörrach

    Loerrach, 79541

  • Klinikum Ludwigsburg

    Ludwigsburg

  • Universitaetsmedizin der Johannes-Gutenberg-Universitaet

    Mainz

  • Klinikum Mannheim GmbH

    Mannheim

  • University Hospital Marburg

    Marburg

  • Kliniken Maria Hilf GmbH

    Mönchengladbach

  • Klinikum Bogenhausen

    München

  • Klinikum Neuperlach

    München

  • Klinikum rechts der Isar

    München

  • Klinikum Nürnberg

    Nuremberg

  • Pius-Hospital Oldenburg

    Oldenburg, 26121

  • Klinikum Oldenburg

    Oldenburg

  • Sana Kliniken Ostholstein

    Oldenburg

  • Paracelsus-Krankenhaus Ruit

    Ostfildern

  • St. Vincenz-Krankenhaus

    Paderborn

  • Oncologianova GmbH

    Recklinghausen

  • Elblandkliniken

    Riesa

  • Vivantes Klinikum

    Spandau

  • Klinikum Stuttgart - Katharinenhospital

    Stuttgard, 70174

  • Kliniken Südostbayern

    Traunstein

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Ulm

    Ulm

  • Horst Schmidt Klinik

    Wiesbaden

  • Marienhospital

    Witten

  • HELIOS Klinikum Wuppertal Medizinische Klinik I

    Wuppertal, 42283

Other trials in Germany

France21 sites

  • Hôpital Jean Minjoz

    Besançon

  • Institut Bergonié

    Bordeaux, 33076

  • CHRU Brest - Hôpital Morvan

    Brest, 29609

  • Hôpital Henri Mondor

    Créteil, 94010

  • Polyclinique du Bois

    La Chaussée-Saint-Victor, 41260

  • Centre Hospitalier Départemental Vendée

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo

    Le Mans, 72000

  • Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez

    Lille, 59037

  • CHU Hôpital de la Timone

    Marseille, 13385

  • Centre Hospitalier Belfort-Montbéliard

    Montbéliard

  • Hôpital Antoine-Béclère

    Paris, 72012

  • Groupe Hosptalier Paris Saint Joseph

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Hôpital Européen Georges Pompidou (HEGP)

    Paris, 75015

  • Hopital Pitie-Salpetriere

    Paris, 75651

  • Gustave Roussy Cancer Campus

    Paris

  • CHU de Poitiers

    Poitiers, 86021

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire

  • Clinique Saint Anne, Strasbourg Oncologie Liberale

    Strasbourg, 67000

  • Hôpital Rangueil

    Toulouse, 31059

Other trials in France

Spain20 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña

  • Hospital Clinic

    Barcelona

  • Hospital de la Santa Creu i Sant Pau

    Barcelona

  • Hospital Universitari Germans Trias i Pujol

    Barcelona

  • Hospital Universitario Vall d'Hebron

    Barcelona

  • Parc Tauli Sabadell Hospital

    Barcelona

  • Hospital Reina Sofía

    Córdoba

  • Hospital de la Santa Creu i Sant Pau

    L'Hospitalet de Llobregat

  • Hospital Universitario Arnau de Vilanova

    Lleida

  • Hospital Clínico San Carlos

    Madrid

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Hospital Regional Universitario Carlos Haya

    Málaga

  • Hospital Universitario Central de Asturias

    Oviedo

  • Hospital Son Llatzer

    Palma de Mallorca

  • Hospital Universitario 12 de Octubre

    Santander

  • Complejo Hospitalario Universitario

    Santiago de Compostela

  • Consorcio Hospital General de Valencia

    Valencia

Other trials in Spain

Italy9 sites

  • Candiolo Cancer Institute

    Candiolo

  • Azienda Ospedaliero-Universitaria Careggi

    Florence

  • University Hospital San Martino

    Genova

  • Ospedale San Raffaele

    Milan

  • Istituto Oncologico Veneto

    Padova

  • Policlinico San Mateo

    Pavia

  • Ospedale Infermi di Rimini, U.O. Oncologia

    Rimini, 47923

  • Ospedale Civile SS Annunziata, U.O.C. Oncologia Medica

    Sassari, 7100

  • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

    Udine

Other trials in Italy

United Kingdom7 sites

  • Aberdeen Royal Infirmary

    Aberdeen

  • The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust - Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Royal Marsden Hospital

    London

  • The Christie Clinic

    Manchester

  • Oxford University Hospitals NHS Trust - Churchill Hospital

    Oxford, OX3 7LE

  • Royal Marsden Hospital

    Sutton

  • York Teaching Hospitals NHS Fondation Trust, Research and Development department

    York, YO31 8HE

Other trials in United Kingdom

Austria4 sites

  • Landesklinikum Krems

    Krems

  • Kaiser-Franz-Josef-Spital

    Vienna

  • Krankenhaus Hietzing

    Vienna

  • Universitätsklinik Wien

    Vienna

Other trials in Austria

Belgium3 sites

  • Onze-Lieve-Vrouwziekenhuis VZW (OLV)

    Aalst, 9300

  • Antwerp University Hospital

    Edegem, 2650

  • UZ Leuven

    Leuven

Other trials in Belgium

Estonia3 sites

  • East-Tallinn Central Hospital

    Tallinn

  • North Estonia Medical Centre

    Tallinn

  • University clinic Tartu

    Tartu

Other trials in Estonia

About this study

Official title: 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.

Read the 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.

Being tested
Usual Maintenance, MGN1703 treatment
Keywords
CRC, mCRC, maintenance treatment, immune modulation, colorectal cancer, immunotherapy, metastatic
Medical subject headings
Colorectal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual MaintenanceOther

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

  • MGN1703 treatmentDrug

    Also called dSLIM

    MGN1703 will be used as single agent maintenance treatment

Study groups in NCT02077868
Study groupRoleWhat they receive
Control Arm AOtherPatients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
Receives: Other: Usual Maintenance
Treatment Arm BExperimentalMGN1703 treatment as maintenance therapy
Receives: Drug: MGN1703 treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival after randomization

    Measured: 36 months

Secondary outcomes (4)

  1. 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

    Measured: 36 months

  2. Safety

    AEs, vital signs, ECGs, safety labs as required

    Measured: 36 months

  3. Overall Response rate

    Complete and partial responses according RECIST 1.1 after randomization

    Measured: 36 months

  4. Quality of life (QoL)

    QoL according EORTC questionnaires

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionFeb 2019
  4. Study completionMay 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
540 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02077868
Sponsor's protocol ID
MGN1703-C06
Acronym
IMPALA
Status last verified
Sep 2019
First submitted
28 Feb 2014
Last updated
10 Sep 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Usual Maintenance and MGN1703 treatment in people with Metastatic Colorectal Cancer, run by Mologen AG at 125 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in Germany, France, Spain, Italy, United Kingdom and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02077868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2019.

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