JPRN-jRCT2080222502未知1 期
A Phase 1, Open-Label, Multicentre Study to Assess the Safety, Tolerability, PK and Preliminary Anti-tumor Activity when given as a monotherapy of Tremelimumab or Tremelimumab in combination with MEDI4736 in Japanese Patients with Advanced Solid Malignancies, and when given as a monotherapy of tremelimumab in Second- or Third-line Treatment of Japanese Subjects with Unresectable Pleural or Peritoneal Malignant Mesothelioma
试验速览
- 阶段
- 1 期
- 发起方
- AstraZeneca
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Part A and B:
- •1. Japanese aged at least 20 years old at a time of enrollment.
- •2. Histological or cytological confirmation of a solid malignant tumor excluding lymphoma that is refractory to standard therapies or for which no
- •standard therapies exist.
- •3. ECOG Performance Status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks at a time of randomization.
- •4. At least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment.
- •5. Adequate bone marrow, hepatic, and renal function
- •6. Willingness to provide consent for archival biopsy samples if available.
- •1. Japanese aged 20 and over at the time of consent
- •2. Histologically and/or cytologically confirmed pleural or peritoneal malignant mesothelioma
- •3. Disease not amenable to curative surgery
- •4. ECOG Performance status 0-1
- •5. Progressed after previous receipt of 1-2 prior systemic treatments for advanced disease that included a first-line pemetrexed (or anti-folate)-based regimen in combination with platinum agent.
- •6. Measurable disease, defined as at least 1 lesion (measurable) that can be accurately assessed at baseline by computed tomography CT or MRI and is suitable for repeated assessment.
- •7. Adequate bone marrow, hepatic, and renal function
排除标准
- •Part A and B:
- •1. Received any prior treatment with monoclonal antibody against Programmed death 1 (PD1), Programmed death ligand 1 (PD-L1) and CTLA-4 (eg, ipilimumab)
- •2. The last dose of prior chemotherapy or radiation therapy was received less than 2 weeks prior to randomization
- •3. Currently receiving systemic corticosteroids or other immunosuppressive medications or has a medical condition that requires the chronic use of corticosteroids.
- •4. Receipt of live attenuated vaccination within 30 days of starting tremelimumab treatment
- •5. Active, untreated central nervous system (CNS) metastasis (subjects with brain metastases who are identified at screening
- •6. History of other malignancy unless the subject has been disease-free for at least 3 years.
- •7. Any unresolved chronic toxicity CTCAE grade 2 or more from previous anticancer therapy at the time of randomization
- •8. Major surgical procedure within 30 days of starting tremelimumab
- •1. Subjects who failed more than 2 prior systemic treatment regimens for advanced malignant mesothelioma
- •2. Received any prior mAb against CTLA-4, PD1 or PD-L1
- •3. History of chronic inflammatory or autoimmune disease.
- •4. Symptomatic, untreated CNS metastasis.
- •5. Any serious uncontrolled medical disorder or active infection that would impair the subject's ability to receive investigational product.
- •6. History of other malignancy.
- •7. History of diverticulitis, inflammatory bowel disease, sarcoidosis syndrome
- •8. Currently receiving systemic corticosteroids or other immunosuppressive medications.
- •9. Vaccinated with live attenuated vaccines within 30 days prior to starting tremelimumab treatment
- •10. Not recovered from all toxicities associated with prior cancer treatment to acceptable baseline status, or a NCI CTCAE Grade of 0 or 1
研究者
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