NCT03679767已完成2 期
A Phase 2 Study of INCMGA00012 (PD-1 Inhibitor) in Participants With Selected Solid Tumors (POD1UM-203)
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
- 121
- 试验地点
- 51
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the clinical activity and safety of INCMGA00012 in participants with advanced solid tumors where the efficacy of PD-1 inhibitors has previously been established.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of one of the following: treatment-naïve metastatic non-small cell lung cancer with high PD-L1 expression (tumor proportion score ≥ 50%) and no epidermal growth factor receptor (EGFR), alkaline phosphatase (ALK), or ROS activating genomic tumor aberrations; locally advanced or metastatic urothelial carcinoma in participants who are not eligible for cisplatin therapy and whose tumors express PD-L1 with a combined positive score ≥ 10; unresectable or metastatic melanoma; locally advanced or metastatic renal cell carcinoma with clear cell component (with or without sarcomatoid features) and having received no prior systemic therapy.
- •Measurable disease per RECIST v1.
- •Eastern Cooperative Oncology Group performance status 0 to
- •Willingness to avoid pregnancy or fathering children.
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.
- •Prior treatment with PD-1 or PD-L1 directed therapy (other immunotherapies may be acceptable with prior approval from the medical monitor).
- •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.
- •Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline (with the exception of anemia not requiring transfusion support and any grade of alopecia). Endocrinopathy, if well-managed, is not exclusionary and should be discussed with sponsor medical monitor.
- •Has not recovered adequately from toxicities and/or complications from surgical intervention before starting study drug.
- •Laboratory values outside the protocol-defined range at screening.
- •Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 3 years of study entry.
- •Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (> 10 mg of prednisone or equivalent).
- •Evidence of interstitial lung disease or active noninfectious pneumonitis.
- •Known active central nervous system metastases and/or carcinomatous meningitis.
- •Known active hepatitis B antigen, hepatitis B virus, or hepatitis C virus infection.
- •Active infections requiring systemic therapy.
- •Known to be HIV-positive, unless all of the following criteria are met: CD4+ count ≥ 300/μL, undetectable viral load, receiving antiretroviral therapy.
- •Known hypersensitivity to another monoclonal antibody that cannot be controlled with standard measures (eg, antihistamines and corticosteroids).
- •Impaired cardiac function or clinically significant cardiac disease.
- •Is pregnant or breastfeeding.
- •Has received a live vaccine within 28 days of the planned start of study drug.
研究组 & 干预措施
Melanoma: retifanlimab 500 mg
Experimental
Participants with melanoma received retifanlimab 500 milligrams (mg) every 4 weeks (Q4W), administered by intravenous (IV) infusion over 30 minutes on Day 1 of each 28-day cycle.
干预措施: Retifanlimab (Drug)
NSCLC: retifanlimab 500 mg
Experimental
Participants with non-small cell lung cancer (NSCLC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
干预措施: Retifanlimab (Drug)
UC: retifanlimab 500 mg
Experimental
Participants with urethelial carcinoma (UC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
干预措施: Retifanlimab (Drug)
RCC: retifanlimab 500 mg
Experimental
Participants with renal cell carcinoma (RCC) received retifanlimab 500 mg Q4W, administered by IV infusion over 30 minutes on Day 1 of each 28-day cycle.
干预措施: Retifanlimab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: up to 25.9 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 determined by the investigator, 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
- Disease Control Rate (DCR)(up to 25.9 months)
- First-dose Cmin of Retifanlimab(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- Duration of Response (DOR)(up to 24.0 months)
- Tmax of Retifanlimab at Steady-state(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days))
- Cmax of Retifanlimab at Steady-state(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days))
- First-dose Cmax of Retifanlimab(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- Overall Survival(up to 28.2 months)
- AUC0-t of Retifanlimab at Steady-state(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days))
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(up to approximately 2.3 years)
- First-dose Tmax of Retifanlimab(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- First-dose AUC0-t of Retifanlimab(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycle 1)
- Progression-free Survival (PFS)(up to 25.9 months)
- Cmin of Retifanlimabv at Steady-state(preinfusion and 10 minutes postinfusion (± 10 minutes) on Day 1 of Cycles 1, 2, 4, and 6 (up to approximately 168 days; each cycle was 28 days))
研究者
研究点 (51)
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