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.
- Conditions
- Metastatic colorectal cancerMedDRA version: 20.0Level: LLTClassification code 10010036Term: Colorectal carcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-000834-50-DE
- Lead Sponsor
- MOLOGEN AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 540
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, within 12-30 weeks from start 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 expected for a patient population recovering after receiving induction treatment. Full recovery is not required at randomization as patients may not receive additional chemotherapy for several weeks while on study. Patients who do receive chemotherapy will be reassessed before the start of the first maintenance cycle.
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). Contraception will start after screening and continue throughout study until at least one month after the last dose of lefitolimod (MGN1703) or longer if required according to the SmPCs of the used standard therapy medications. 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
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 (present or treated)
3. Contraindication to receiving lefitolimod (MGN1703) as per current investigator's brochure
4. Known hypersensitivity to any components of the study product
5. Prior allogeneic stem cell transplantation or organ transplantation.
6. Active or uncontrolled infections or undiagnosed febrile condition.
7. Severe anemia requiring repeated blood cell transfusion
8. Pre-existing autoimmune or antibody mediated diseases or immune deficiency
9. 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
10. Use of systemic antibiotic therapy within the last 2 weeks prior to start of study treatment
11. 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
12. HIV seropositivity or active HBV/HCV infection
13. Serious concomitant disease or a medical condition that in the judgment of the investigator renders the patient at high risk of treatment complications
14. Female patient who is pregnant or breast feeding
15. Contraindication to receiving the planned standard maintenance treatment according to applicable SmPC
16. 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.
17. Vaccination within 1 month prior to start of study treatment
18. 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method