Clinical trial NCT02077868 (phase 3, status: active, not recruiting)
Conditions: metastatic colorectal cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2
Drugs: mgn1703 treatment
SMILES: COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1
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