NCT06581406招募中2 期
A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 59
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are 18 years of age or older at the time of signed informed consent.
- •Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
- •Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node [LN]) that is amenable to serial RP2 injections.
- •Must be willing to provide tumor biopsy samples.
- •LDH ≤ 2 × upper limit of normal (ULN).
- •Has adequate hematologic, hepatic and renal function
- •Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or
- •Life expectancy of > 6 months as estimated by the Investigator.
排除标准
- •Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
- •Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- •Current active significant herpetic infections or prior complications of HSV-1 infection.
- •Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
- •Major surgery ≤ 2 weeks prior to the first dose of study intervention.
- •Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
- •Active, known, or suspected autoimmune disease requiring systemic treatment.
- •Prior treatment with an oncolytic virus.
- •Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
- •Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
- •Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
- •Conditions requiring treatment with immunosuppressive doses (> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.
- •Additional inclusion/ exclusion criteria are outlined in the study protocol
研究组 & 干预措施
Control Arm (Active Comparator): ipilimumab + nivolumab
Experimental
Immune Checkpoint inhibitor combination
干预措施: Ipilimumab (Biological)
Test Arm: RP2 + nivolumab
Experimental
RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor)
干预措施: RP2 (Biological)
Test Arm: RP2 + nivolumab
Experimental
RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor)
干预措施: Nivolumab (Biological)
Control Arm (Active Comparator): ipilimumab + nivolumab
Experimental
Immune Checkpoint inhibitor combination
干预措施: Nivolumab (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: From Day 1 up to 3 years after last dose.
OS is the time from the date of randomization to death from any cause.
Progression Free Survival (PFS)
时间窗: From Day 1 up to 3 years after last dose.
PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.
次要结局
- Number of patients with treatment-emergent adverse events (TEAEs)(From first dose up to 100 days after last dose.)
- Overall Response Rate (ORR)(Every 12 weeks from Day 1 up to 3 years after last dose.)
- Disease Control Rate (DCR)(Every 12 weeks from Day 1 up to 3 years after last dose.)
研究者
研究点 (59)
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