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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mologen AG

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