A Phase 2 Study of INCMGA00012 in Participants With Squamous Carcinoma of the Anal Canal Who Have Progressed Following Platinum-Based Chemotherapy (POD1UM-202)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 46
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the efficacy of INCMGA00012 in participants with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed after platinum-based 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
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to comprehend and willingness to sign a written informed consent form.
- •Confirmed diagnosis of locally advanced or metastatic SCAC.
- •Must have received (or been intolerant to or ineligible for) at least 1 prior line of platinum-based chemotherapy and received no more than 2 prior systemic treatments.
- •Must have measurable disease by RECIST v1.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •If HIV-positive, then all of the following criteria must also be met: CD4+ count ≥ 300/μL, undetectable viral load, and receiving highly active antiretroviral therapy.
排除标准
- •Receipt of anticancer therapy or participation in another interventional clinical study within 21 days before the first administration of study drug; 6 weeks for mitomycin C.
- •Radiotherapy within 14 days of first dose of study treatment with the following caveats: 28 days for pelvic radiotherapy, 6 months for thoracic region radiotherapy that is > 30 Gy.
- •Prior treatment with programmed cell death protein 1 (PD-1) or programmed cell death ligand protein 1 (PD-L1)-directed therapy.
- •Active autoimmune disease requiring systemic immunosuppression.
- •Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
- •Known active hepatitis infection.
- •Active infections requiring systemic therapy.
- •Is pregnant or breastfeeding or is expecting to conceive or father children within the projected duration of the study, from screening through 6 months after the last dose of study drug.
研究组 & 干预措施
Retifanlimab 500 mg
Retifanlimab 500 milligrams (mg) intravenously every 4 weeks (Q4W).
干预措施: Retifanlimab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months
ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1), as assessed by independent central radiographic (ICR) review, at any post-Baseline visit until new anti-cancer therapy or first Progressive Disease. CR: disappearance of all target and non-target lesions and no appearance of any new lesions. Any pathological lymph nodes (whether target or non-target) must have a reduction in the short axis to \<10 millimeters (mm). PR: complete disappearance or at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference the baseline sum diameters, no new lesions, and no progression of non-target lesions.
次要结局
- Progression-free Survival (PFS)(up to 16.8 months)
- Cmax of Retifanlimab(pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6)
- Disease Control Rate (DCR)(Cycle 1 Day 1, and every 4 weeks throughout the study, up to approximately 24 months)
- Tmax of Retifanlimab(pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6)
- Cmin of Retifanlimab(pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6)
- AUC0-t of Retifanlimab(pre-infusion on Day 1 of Cycles 1, 2, 4, 6, and 7; 10 minutes and 4 hours post-infusion on Day 1 of Cycles 1 and 6)
- Duration of Response (DOR)(up to 18.2 months)
- Overall Survival(up to 28.2 months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(up to 913 days)