EUCTR2014-000834-50-ES进行中（未招募）1 期
IMPALA-Trial: Evaluation of an immunomodulatory maintenance treatment in patients with metastatic colorectal cancer with tumor reduction during induction treatment - A phase III trial - IMPALA trial
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MOLOGEN AG
- 入组人数
- 540
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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
研究者
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