A Phase II, Multi-Center Study to Evaluate the Efficacy and Safety of Volrustomig as Monotherapy or in Combination With Anti-cancer Agents in Participants With Advanced/Metastatic Solid Tumors
概览
- 阶段
- 2 期
- 干预措施
- Volrustomig
- 疾病 / 适应症
- Sub-study 1 Cervical Cancer (Volrustomig Monotherapy)
- 发起方
- AstraZeneca
- 入组人数
- 257
- 试验地点
- 60
- 主要终点
- Objective response rate (ORR)
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
eVOLVE-02 study will evaluate the efficacy and safety of volrustomig as monotherapy or in combination with anti-cancer agents in participants with advanced/metastatic solid tumors.
详细描述
eVOLVE-02 study will evaluate volrustomig monotherapy or volrustomig-based combination therapy in various advanced or metastatic solid tumors. In sub-study 1, volrustomig will be evaluated as monotherapy in approximately 30 evaluable participants with cervical cancer. In sub-study 2, volrustomig will be evaluated as monotherapy in approximately 20 evaluable participants with head and neck squamous cell carcinoma. In sub-study 3, Volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with head and neck squamous cell carcinoma. In sub-study 4, volrustomig in Combination with Chemotherapy will be evaluated in approximately 60 evaluable participants with esophagus squamous cell carcinoma. In sub-study 5, volrustomig will be evaluated as monotherapy in approximately 75 evaluable participants with unresectable pleural mesothelioma.
研究者
入排标准
入选标准
- •Age ≥18 at the time of signing the ICF.
- •Provision of tumor sample to assess the PD-L1 expression (if applicable).
- •ECOG performance status of 0 or
- •Measurable disease according to RECIST 1.1 (variations of RECIST 1.1 if applicable).
- •Life expectancy ≥ 12 weeks.
- •Adequate organ and bone marrow function.
- •Body weight \> 35 kg
- •Capable of giving signed informed consent.
排除标准
- •Spinal cord compression.
- •For sub-study 1,2,3,4, brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. For sub-study 5, participants with untreated or progressive brain metastases.
- •For sub-study 1,2,3, participants with primary neuroendocrine, mesenchymal, sarcomatoid histologies, or other histologies not mentioned as part of the inclusion criteria.
- •Have not recovered (ie, ≤ Grade 1 or at baseline) from an AE due to a previously administered anti-cancer therapy.
- •For sub-study 2, have had radiotherapy within 2 weeks prior to enrollment.
- •For sub-study 3,4, participants have contraindications to any of the following drugs: 5-FU, paclitaxel and carboplatin
- •History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention and of low potential risk for recurrence; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.
- •Any evidence of diseases, and/or history of organ transplant or allogenic stem cell transplant, which makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- •Evidence of the following infections: active infection including tuberculosis; known HIV infection. that is not well controlled; active or uncontrolled HBV or HCV; or active hepatitis A.
- •History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.
研究组 & 干预措施
Sub-study 1
Volrustomig monotherapy
干预措施: Volrustomig
Sub-study 2
Volrustomig monotherapy
干预措施: Volrustomig
结局指标
主要结局
Objective response rate (ORR)
时间窗: Through study completion, an average of 4 years
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by Investigator per RECIST 1.1.
The number of participants with adverse events/serious adverse events
时间窗: Through study completion, an average of 4 years
Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.
次要结局
- Duration Of Response (DOR)(Through study completion, an average of 4 years)
- Progression free survival (PFS)(Through study completion, an average of 4 years)
- Time to response (TTR)(Through study completion, an average of 4 years)
- Overall Survival (OS)(Through study completion, an average of 4 years)
- PK of volrustomig(Through study completion, an average of 4 years)
- The immunogenicity of volrustomig(Through study completion, an average of 4 years)
- Disease control rate (DCR)(Through study completion, an average of 4 years)
- PFS landmark(Through study completion, an average of 4 years)
- OS landmark(Through study completion, an average of 4 years)