EUCTR2018-001773-24-DE进行中（未招募）1 期
A PHASE II, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF RO7198457 IN COMBINATION WITH PEMBROLIZUMAB VERSUS PEMBROLIZUMAB IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED MELANOMA. - IMCODE001
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
- 132
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 at time of signing the Informed Consent Form
- •- Able to comply with the study protocol, in the investigator's judgment
- •- Histologically confirmed metastatic (recurrent or de novo Stage IV) or unresectable locally advanced (Stage IIIC or IIID) cutaneous, acral, or mucosal melanoma, as defined by the AJCC v8.0
- •- ECOG Performance Status of 0 or 1
- •- Life expectancy >= 12 weeks
- •- Adequate hematologic and end-organ function
- •- Measurable disease per RECIST v1.1
- •- Naive to prior systemic anti-cancer therapy for advanced melanoma, with the exceptions as specified in the protocol
- •- Tumor specimen availability.
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •- Ocular/uveal melanoma
- •- Significant cardiovascular disease
- •- Known clinically significant liver disease
- •- Previous splenectomy
- •- Any anti-cancer therapy with the exceptions as specified in the protocol
- •- History of autoimmune disease
- •- Positive test for HIV infection
- •- Active hepatitis B or C
- •- Known active or latent tuberculosis infection
- •- Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
研究者
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