A Phase II, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of Volrustomig Priming Regimens in Combination with Other Anticancer Agents in Participants with Solid Tumors (eVOLVE 01).
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 36
- 主要终点
- The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
研究概览
简要总结
To assess the safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors. To assess the efficacy of volrustomig in combination with other anticancer drugs in participants with specified solid tumors by assessment of ORR in participants.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Screening Period / Treatment Period / Follow Up
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no deterioration
- •Life expectancy greater than or equal to (>=) 12 weeks
- •Adequate organ and bone marrow function.
- •Body weight greater than (>= 35) kilograms (kg) at screening and at randomization.
- •Histologically or cytologically documented NSQ NSCLC.
- •Absence of sensitizing epidermal growth factor receptor (EGFR) mutations.
- •Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
- •At least one measurable lesion not previously irradiated that can be accurately measured at baseline as >= 10 millimeter (mm) in the longest diameter.
排除标准
- •Spinal cord compression.
- •History of primary active immunodeficiency.
- •Active or prior documented autoimmune or inflammatory disorders.
- •Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant.
- •Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of radiation therapy and study enrollment.
- •Prior chemotherapy or any other systemic therapy for Stage IV NSCLC. Participants who have received prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for advanced disease are eligible, provided that progression has occurred greater(>) 12 months from end of last therapy.
研究组 & 干预措施
volrustomig
Participants receiving volrustomig
干预措施: volrustomig (Drug)
结局指标
主要结局
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
ORR is defined as the percentage of participants who have a complete response (CR) or partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
次要结局
- DOR is defined as the time from the date of first documented response until the date of documented progression or death due to any cause (in the absence of progression).
- PFS is defined as the time from randomization or first dose until radiological progression or death due to any cause (in the absence of progression).
- OS is defined as the time from randomization or first dose until the date of death due to any cause.
- The serum concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
- The AUC concentrations of volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
- The trough concentrations volrustomig alone and when used in combination with other anticancer agents in participants with pre-specified solid tumors will be assessed.
- The incidence of ADAs against volrustomig or other anticancer agents in serum will be assessed.
- DCR is defined as the percentage of participants who have a CR or PR or who have stable disease (SD) after the date of randomization or first dose.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB