NCT04246489已完成2 期
A Phase II, Multicenter, Open Label Study of Bintrafusp Alfa (M7824) Monotherapy in Participants With Advanced, Unresectable Cervical Cancer With Disease Progression During or After Platinum-Containing Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 73
- 主要终点
- Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
研究概览
简要总结
The main purpose of this study was to evaluate clinical efficacy and safety of bintrafusp alfa in participants with advanced, unresectable cervical cancer with disease progression during or after platinum-containing chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who had advanced unresectable and/or metastatic cervical cancer (squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma) with disease progression during or after the prior platinum-containing chemotherapy:
- •The prior platinum-containing chemotherapy may be a systemic treatment for advanced unresectable, recurrent, persistent or metastatic disease or treatment in the adjuvant or neo-adjuvant setting with disease progression or recurrence within 6 months of completion of platinum-containing chemotherapy
- •Participants who previously only received platinum as a radiosensitizer are not eligible
- •Participants must be naïve to checkpoint inhibitors
- •Participants who had measurable disease
- •Participants who provide a tumor tissue sample, either from archival tissue or newly obtained core or excisional biopsy. If the participant received local therapy (For example: radiation therapy or chemoradiotherapy) after the archival tissue was taken, a new biopsy was required
- •Participants who had Eastern Cooperative Oncology Group (ECOG) PS of 0 to 1
- •Life expectancy greater than or equals to (>=) 12 weeks as judged by the Investigator
- •Adequate hematological, hepatic and renal function as defined in the protocol
- •Participants with known Human Immunodeficiency Virus (HIV) infections were in general eligible if the following criteria are met:
- •Clinically indicated participants must be stable on antiretroviral therapy (ART) for at least 4 weeks and agree to adhere to ART
- •had no evidence of documented multi-drug resistance that would prevent effective ART
- •had an HIV viral load of < 400 copies per milliliter (/mL) at Screening
- •had CD4+ T-cell (CD4+) counts >= 350 cells/microliter
- •For participants with a history of an Acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the last 12 months, participants may be eligible only after consultation and agreement with the study Medical Monitor
- •If prophylactic antimicrobial drugs were indicated, participants would still be considered eligible upon agreement with the study Medical Monitor
- •Participants with hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infections were in general eligible if the following criteria are met:
- •HBV viral load below the limit of quantification. If medically indicated, participants infected with HBV must be treated and on a stable dose of antivirals at study entry and with planned monitoring and management according to appropriate labeling guidance
- •Participants with a history of HCV infection should have completed curative antiviral treatment and require HCV viral load below the limit of quantification
- •Participants on concurrent HCV treatment should have HCV below the limit of quantification
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participants with active central nervous system (CNS) metastases causing clinical symptoms or require therapeutic intervention are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they have fully recovered from treatment, demonstrated no progression for at least 4 weeks, and are not using steroids for at least 7 days prior to the start of study treatment
- •Participants with interstitial lung disease or has had a history of pneumonitis that has required oral or intravenous (IV) steroids
- •Participants with significant acute or chronic infections
- •Participants with active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
- •Participants with clinically significant cardiovascular/cerebrovascular disease including: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, or serious cardiac arrhythmia
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Bintrafusp alfa
Experimental
干预措施: Bintrafusp alfa (Drug)
结局指标
主要结局
Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
时间窗: Time from first treatment up to 688 days
Confirmed objective response was defined as the number of participants with a confirmed objective response of complete response (CR) or partial response (PR). CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30% reduction from baseline in the sum of the longest diameter (SLD) of all lesions. Confirmed CR = at least 2 determinations of CR at least 4 weeks apart and before progression. Confirmed PR = at least 2 determinations of PR at least 4 weeks apart and before progression (and not qualifying for a CR). Confirmed objective response was determined according to RECIST v1.1 and as adjudicated by IRC.
次要结局
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)(Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days)
- Number of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by the Investigator(Time from first treatment up to 688 days)
- Overall Survival (OS)(Time from first administration of study drug up to data cutoff (assessed up to 688 days))
- Serum Pre-Dose Concentrations (Ctrough) of Bintrafusp Alfa(At Day 15, Day 29, Day 43, Day 85, Day 127, Day 169, Day 253, Day 337, Day 421, Day 505 and Day 589)
- Serum Concentration at End of Infusion (CEOI) of Bintrafusp Alfa(At Day 1 and Day 29)
- Number of Participants With Positive Antidrug Antibodies (ADA)(Time from first treatment up to 688 days)
- Percentage of Participants With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first treatment up to 688 days)
- PFS According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC) According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first administration of study drug until the first documentation of PD or death, assessed up to 688 days)
- Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)(Time from first treatment up to 688 days)
- Durable Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)(Time from first treatment up to 688 days)
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs, Including Adverse Event of Special Interests (AESIs)(Time from first treatment up to 688 days)
- Overall Survival (OS) as Assessed According to Programmed Death Ligand 1 (PD-L1) Expression(Time from first administration of study drug up to 688 days)
研究者
研究点 (73)
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