A trial to assess the effectiveness of treatment with MGN1703 in further delaying the time of first tumour progression in patients with metastatic colorectal cancer that have already experienced tumor reduction after receiving treatment with standard first-line chemotherapy.

Phase 1

• Conditions: Metastatic colorectal cancer; MedDRA version: 17.0 Level: LLT Classification code 10010036 Term: Colorectal carcinoma System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-000834-50-ES
• Lead Sponsor: MOLOGEN AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-09
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 540

Inclusion Criteria

1. Signed written informed consent
2. Male or female patient 18 years or older
3. Histologically confirmed diagnosis of colorectal cancer presenting with unresectable stage IV (UICC) disease (primary tumor may be present)
4. Complete or partial response, as assessed by local investigators according to RECIST 1.1, after 12-30 weeks of induction treatment with standard first-line chemotherapy with or without biological agents
5. ECOG PS 0-1
6. Haematology and biochemistry laboratory results within the limits normally expected for the patient population:
- Absolute neutrophil count >= 1.0x10 9/L
- Platelet count >= 100x10 9/L
- Leukocyte count >= 3.0x10 9/L
- Lymphocytes >= 1.0x10 9/L
- Haemoglobin >= 9.0 g/dL or 5.59 mmol/L
- Total bilirubin <=2 times the upper limit of normal (ULN)
- AST <=3xULN in absence of liver metastases, or <=5.0xULN in presence of liver metastases
- ALT <=3xULN in absence of liver metastases, or <=5.0xULN in presence of liver metastases
- Serum creatinine <=1.5xULN

7. Male and female patients of childbearing potential (i.e. not post-menopausal for at least 24 consecutive months and did not undergo surgical sterilization: hysterectomy, bilateral tubal ligation, or bilateral oophorectomy for women, vasectomy for men) using an effective means of contraception with a failure rate of less than 1% per year, e.g. established use of oral, implanted or injected hormonal contraceptives; placement of intra-uterine device (IUD) or intra-uterine system (IUS); use of barrier methods such as condom or diaphragm together with spermicide product; true abstinence (when it is in line with preferred and usual lifestyle of the patient). Females of child bearing potential must have a negative serum pregnancy test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 297
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 243

Exclusion Criteria

1. History of other malignant tumors within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
2. Known brain metastases
3. Contraindication to receiving MGN1703 as per current investigator's brochure
4. Presence of acute bacterial infection or undiagnosed febrile condition
5. Pre-existing autoimmune or antibody mediated diseases
6. Chronic systemic immune therapy or immunosuppressant medication within the last 6 weeks; continuous steroid treatment within the last 2 weeks prior to randomization
7. Use of antibiotic therapy within the last 2 weeks prior to randomization
8. 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
9. HIV seropositivity or active HBV/HCV infection
10. Serious concomitant disease or a medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications
11. Female patient who is pregnant or breast feeding
12. Contraindication to receiving the planned standard maintenance treatment according to applicable SmPC
13. Treatment with any investigational drug within 12 months prior to randomization
14. Vaccination within 1 month prior to randomization
15. 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified