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
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 194
- 试验地点
- 63
- 主要终点
- Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Purpose of this study is to assess the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of volrustomig in combination with other anticancer drugs in participants with specified solid tumors.
详细描述
This Phase II, platform, open-label, multicenter study will evaluate the efficacy, safety, and tolerability of volrustomig in combination with anticancer drugs in various solid tumor types.
This platform study currently includes 2 substudies:
Substudy 1: metastatic non-small cell lung cancer (mNSCLC) (non-squamous [NSQ]). Participants will be randomized in two treatment arms: Arm 1A and Arm 1B.
Substudy 2: mNSCLC (squamous [SQ] or NSQ). Participants will enroll to the Arm 2A only.
All arms will test a volrustomig dosing in combination with chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 in substudy 1 and SQ or NSQ mNSCLC in substudy
- •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 local disease are eligible, provided that progression has occurred greater (>) 12 months from end of last therapy.
研究组 & 干预措施
Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
干预措施: Volrustomig (Drug)
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
干预措施: Paclitaxel (Drug)
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
干预措施: Carboplatin (Drug)
Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
干预措施: Volrustomig (Drug)
Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
干预措施: Carboplatin (Drug)
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
干预措施: Pemetrexed (Drug)
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
干预措施: Ramucirumab (Drug)
Substudy 1: Arm 1A: Volrustomig dose regimen 1 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 1 in combination with carboplatin and pemetrexed.
干预措施: Pemetrexed (Drug)
Substudy 2: Arm 2A: Volrustomig dose regimen 2 +Ramucirumab + Carboplatin + Pemetrexed or Paclitaxel
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with ramucirumab and histology-specific chemotherapy (carboplatin+ either pemetrexed or paclitaxel).
干预措施: Volrustomig (Drug)
Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
干预措施: Carboplatin (Drug)
Substudy 1: Arm 1B: Volrustomig dose regimen 2 + Carboplatin and Pemetrexed
Volrustomig priming dose followed by volrustomig dosing regimen 2 in combination with carboplatin and pemetrexed.
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From screening (Days -28 to Day -1) up to 2 year 10 months
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Confirmed Objective Response rate (ORR)
时间窗: Up to 2 year 10 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From screening (Days -28 to Day -1) up to 2 year 10 months
The safety and tolerability of volrustomig in combination with other anticancer drugs in participants with specified solid tumors will be assessed.
Confirmed Objective Response rate (ORR)
时间窗: Up to 2 year 10 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
次要结局
- Area Under the Curve (AUC)(Up to 2 year 10 months)
- Number of Participants with Positive Antidrug Antibodies (ADAs)(Up to 2 year 10 months)
- Disease Control Rate (DCR)(Up to 2 year 10 months)
- Duration of Response (DOR)(Up to 2 year 10 months)
- Progression Free Survival (PFS)(Up to 2 year 10 months)
- Overall Survival (OS)(Up to 2 year 10 months)
- Serum Concentration of Volrustomig(Up to 2 year 10 months)
- Trough concentration (Ctrough)(Up to 2 year 10 months)
- Maximum Observed Concentration (Cmax)(Up to 2 year 10 months)
- Disease Control Rate (DCR)(Up to 2 year 10 months)
- Duration of Response (DOR)(Up to 2 year 10 months)
- Progression Free Survival (PFS)(Up to 2 year 10 months)
- Overall Survival (OS)(Up to 2 year 10 months)
- Serum Concentration of Volrustomig(Up to 2 year 10 months)
- Trough concentration (Ctrough)(Up to 2 year 10 months)
- Maximum Observed Concentration (Cmax)(Up to 2 year 10 months)
- Area Under the Curve (AUC)(Up to 2 year 10 months)
- Number of Participants with Positive Antidrug Antibodies (ADAs)(Up to 2 year 10 months)