NCT02077868Unknown3 期
Evaluation of an Immunomodulatory Maintenance Treatment in Patients With Metastatic Colorectal Cancer With Tumor Reduction During Induction Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- Mologen AG
- 入组人数
- 540
- 试验地点
- 121
- 主要终点
- Overall survival
研究概览
简要总结
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.
详细描述
Due to the toxicity of chemotherapeutic medications treatment breaks are common practice in the treatment of metastatic colorectal cancer. During these treatment breaks a variety of maintenance treatments are available.
MGN1703 is developed not only to help the Patient to recover from chemotherapy but also to boost the patient's immune System and thus help him to effectively fight the Tumor himself.
After the concept has already been proved in a previous study this Trial is conducted to further evaluate the safety and efficacy of MGN1703 Treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Arm B
Experimental
MGN1703 treatment as maintenance therapy
干预措施: MGN1703 treatment (Drug)
Control Arm A
Other
Patients in Control Arm A receive usual maintenance Treatment according to local investigator's decsision
干预措施: Usual Maintenance (Other)
结局指标
主要结局
Overall survival
时间窗: 36 months
Overall survival after randomization
次要结局
- Progression Free Survival (PFS)(36 months)
- Safety(36 months)
- Overall Response rate(36 months)
- Quality of life (QoL)(36 months)
研究者
研究点 (121)
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