A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 456
- 试验地点
- 117
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a Phase 3, multicenter, open-label, randomized study of nemvaleukin in combination with pembrolizumab versus protocol-specific Investigator's choice chemotherapy in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
详细描述
Patients will be centrally allocated in a randomized fashion (3:1:1:3) to receive either:
Arm 1: Nemvaleukin and pembrolizumab combination therapy Arm 2: Pembrolizumab monotherapy Arm 3: Nemvaleukin monotherapy Arm 4: Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine.
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
- Single (Outcomes Assessor)
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
- •Patient is female and ≥18 years of age.
- •Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.
- •Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.
- •Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.
- •Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.
- •Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.
排除标准
- •Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).
- •Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.
- •Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).
- •Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.
- •Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.
- •Patient has prior exposure to any anti-PD1/PD-L1 therapy.
研究组 & 干预措施
Nemvaleukin and Pembrolizumab Combination
干预措施: Nemvaleukin and Pembrolizumab Combination (Biological)
Pembrolizumab (enrollment completed)
干预措施: Pembrolizumab (Biological)
Nemvaleukin (enrollment completed)
干预措施: Nemvaleukin (Biological)
Investigator's Choice
Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
干预措施: Pegylated Liposomal Doxorubicin (PLD) (Drug)
Investigator's Choice
Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
干预措施: Paclitaxel (Drug)
Investigator's Choice
Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
干预措施: Topotecan (Drug)
Investigator's Choice
Options for protocol-specific Investigator's choice chemotherapy include one of the following: pegylated liposomal doxorubicin (PLD), paclitaxel, topotecan, or gemcitabine. The Investigator will pre-select the Investigator's choice treatment before the randomization of each patient.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From the first dose of study drug up to 24 months
Estimates based on Kaplan-Meier method.
次要结局
- Objective Response Rate (ORR) as Assessed by Investigator(From the first dose of study drug up to 20 months)
- Disease Control Rate (DCR) as Assessed by Investigator(From the first dose of study drug up to 20 months)
- Duration of Response (DOR) as Assessed by Investigator(From the first dose of study drug up to 20 months)
- Time to Response (TTR) as Assessed by Investigator(From the first dose of study drug up to 20 months)
- Percentage of Participants With Cancer Antigen (CA)-125 Response as Defined by the Gynecologic Cancer Inter Group (GCIG)(From the first dose of study drug up to 20 months)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(From first dose of study drug up to 90 days after last dose (up to 23 months))
- Progression-free Survival (PFS) as Assessed by Investigator(From the first dose of study drug up to 20 months)