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Evaluation of MGN1703 Maintenance Treatment in Patients With mCRC With Tumor Reduction During Induction Treatment | Clinical Trials | Clareo Health

UNKNOWNPHASE3

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

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

NCT02077868•Mologen AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+8 more criteria

Locations (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, Belgium

Antwerp University Hospital

Edegem, Belgium

UZ Leuven

Leuven, Belgium

East-Tallinn Central Hospital

Tallinn, Estonia

North Estonia Medical Centre

Tallinn, Estonia

University clinic Tartu

Tartu, Estonia

Key Dates

Start Date

September 1, 2014

Primary Completion Date

February 1, 2019

Completion Date

May 1, 2020

Last Updated

September 10, 2019

Enrollment

540

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Usual Maintenance

OTHER

MGN1703 treatment

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

View study

RECRUITINGPHASE1/PHASE2

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068

Advanced CancerMetastatic Cancer+7 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

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