EUCTR2021-002147-29-ES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 TREATMENT COMBINATIONS IN PATIENTS WITH MELANOMA - MORPHEUS MELANOMA
Roche Farma S. A. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd0 个研究点目标入组 231 人开始时间: 2021年8月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 231
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
- •- Availability of a representative tumor specimen that is suitable for determination of PD-L1 and/or additional biomarker status via central testing
- •- Adequate hematologic and end-organ function
- •- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •- Negative HIV test at screening
- •- Negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test at screening. If a patient has a negative hepatitis B surface antigen (HBsAg) test and a positive total HBcAb test at screening, an hepatitis B virus (HBV) DNA test must also be performed to rule out active HBV.
- •- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive measures
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm
- •Inclusion Criteria for Cohort 1
- •- ECOG performance status (PS) of 0 or 1
- •- Histologically confirmed resectable Stage III melanoma and no history of in-transit metastases within the last 6 months
- •- Fit and planned for completion lymph node dissection (CLND)
- •- Measurable disease (at least one target lesion) according to RECIST v1.1
- •Inclusion Criteria for Cohort 2
- •- Patients must meet all of the following criteria to qualify for Cohort 2:
- •- ECOG PS of 0, 1, or 2
- •- Life expectancy >= 3 months, as determined by the investigator
- •- Histologically confirmed Stage IV (metastatic) melanoma according to AJCC-8
- •- Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
- •- Measurable disease (at least one target lesion) according to RECIST v1.1
- •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 231
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria for Cohort 1 and Cohort 2
- •- Mucosal and uveal melanoma. Acral lentiginous melanoma (excluded in Cohort 1)
- •- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- •- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- •- Prior allogeneic stem cell or solid organ transplantation
- •- Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication
- •- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
- •- Active or history of autoimmune disease or immune deficiency
- •- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •- History of malignancy other than malignant melanoma within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
- •- Active tuberculosis (TB)
- •- Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the investigator, could impact patient safety
- •- Treatment with therapeutic or prophylactic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
- •- Significant cardiovascular disease such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
- •- Uncontrolled hypertension
- •- 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 other than CLND, during the study.
- •- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, impair the ability of the patient to participate in the study, or may render the patient at high risk from treatment complications
- •- History of severe allergic reactions to chimeric or humanized antibodies or fusion proteins
- •- Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies
- •- Known allergy or hypersensitivity to any of the study drugs or their excipients
- •- Known intolerance to any of the drugs required for premedication
- •- Pregnancy or breastfeeding, or intention of becoming pregnant during the study. Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
- •- Eligible only for the control arm
- •Exclusion Criteria for Cohort 1
- •- Distantly metastasized melanoma
- •- History of in-transit metastases within the last 6 months
- •- Prior radiotherapy
- •- Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
- •Exclusion Criteria for Cohort 2
- •- Symptomatic, untreated, or progressing CNS metastases
- •- Active or history of carcinomatous m
研究者
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