EUCTR2017-004566-99-GB进行中（未招募）1 期
A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED UMBRELLA STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE IMMUNOTHERAPY-BASED TREATMENT COMBINATIONS IN PATIENTS WITH METASTATIC COLORECTAL CANCER (MORPHEUS-CRC)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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
- 性别
- All
入选标准
- •- Age >=18 years
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Life expectancy >= 3 months, as determined by the investigator
- •- Histologically confirmed adenocarcinoma originating from the colon or rectum
- •- Metastatic disease not amenable to local treatment
- •- Disease progression during or following not more than two separate lines of treatment for mCRC that consisted of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy in combination with a biologic agent but not other agents
- •- Availability of a representative tumor specimen that is suitable for determination of Programmed cell Death-1 (PD-L1) and/or additional biomarker status by means of central testing
- •- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen during the 14 days prior to initiation of study treatment
- •- Negative HIV test and hepatitis B surface antigen test at screening
- •- Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
- •- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- Tumor accessible for biopsy
- •- For women and men: agreement to remain abstinent or use contraceptive measures as outlined for each specific treatment arm
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •- High microsatellite instability tumor
- •- Mutation in the BRAF oncogene
- •- Prior treatment with any of the protocol-specified study treatments with the exception of patients who received bevacizumab for treatment of CRC.
- •- Eligibility only for the control arm
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Symptomatic, untreated, or actively progressing central nervous system metastases
- •- History of leptomeningeal disease
- •- Active or history of autoimmune disease or immune deficiency, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
- •- History of malignancy other than CRC within 2 years prior to screening
- •- Active tuberculosis
- •- Severe infection within 4 weeks prior to initiation of study treatment
- •- Significant cardiovascular disease
- •- Grade >= 3 hemorrhage or bleeding event within 28 days prior to initiation of study treatment
- •- Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •- Adverse events from prior anti-cancer therapy that have not improved to Grade <= 1 or better, with the exception of alopecia of any grade and Grade <= 2 peripheral neuropathy
研究者
相似试验
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma)MelanomaEUCTR2021-002147-29-NLF. Hoffmann-La Roche Ltd336
进行中（未招募）
1 期
A Study to Evaluate Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Patients with Metastatic Non-Small Cell Lung Cancer (Morpheus-Lung)on-small cell lung cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001267-21-ESF. Hoffman-La Roche Ltd.300
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients with Melanoma (Morpheus-Melanoma)MedDRA version: 20.0Level: HLTClassification code 10027156Term: Skin melanomas (excl ocular)System Organ Class: 100000004858MelanomaEUCTR2021-002147-29-ITF. HOFFMANN - LA ROCHE LTD.231
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with CHOP or CHP-Polatuzumab Vedotin in Patients with B Cell Non-Hodgkin LymphomaB-Cell Non-Hodgkin Lymphoma (B-cell NHL)MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2018-001039-29-ESF. Hoffmann-La Roche Ltd160
进行中（未招募）
1 期
A Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatment Combinations in Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Carcinoma After Failure with Platinum Containing Chemotherapy (Morpheus-mUC)rothelial carcinoma (UC)MedDRA version: 20.0 Level: LLT Classification code 10064467 Term: Urothelial carcinoma System Organ Class: 100000004864EUCTR2017-004634-28-ESF. Hoffmann-La Roche Ltd305