PACTR202106740461845尚未招募2 期
A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 255
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Major lesion was histologically confirmed esophageal squamous-cell carcinoma (ESCC)
- •Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization; or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence within 24 weeks after the last dose of the treatment
- •Radiologically measurable disease according to RECIST v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy
- •Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- •A life expectancy of at least (=)12 weeks
- •Tissue samples must be provided for analysis of anti-programmed death ligand-1 (PD-L1) tumor positivity
- •Adverse events from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade =1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy
- •Adequate cardiovascular, hematological, liver, and renal function
- •Serum albumin =25 grams per liter (g/L),
- •For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time =1.5 times (×) the upper limit of normal (ULN); for participants receiving therapeutic anticoagulation: stable anticoagulant regimen
- •A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP), or a WOCBP who agrees to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization.
- •A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a c
排除标准
- •Pregnancy, lactation, or breastfeeding
- •Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies
- •Patients with significant malnutrition. Patients whose nutrition has been well controlled for =28 days prior to randomization may be enrolled
- •Evidence of complete esophageal obstruction not amenable to treatment
- •Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree)
- •Symptomatic central nervous system (CNS) metastases
- •Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for =14 days prior to randomization
- •Active or history of carcinomatous meningitis/leptomeningeal disease
- •Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization
- •Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry
- •Active second malignancy (with some exceptions)
- •Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.).
- •Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent
- •Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization
- •Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis [TB] and typical mycobacterial disease), parasitic, or other infection (excluding fungal
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