An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 206
- 试验地点
- 130
- 主要终点
- Group A - Objective Response Rate
研究概览
简要总结
This is a multicenter, open-label, nonrandomized, Phase 2 umbrella study of retifanlimab in participants who have advanced or metastatic endometrial cancer that has progressed on or after platinum-based chemotherapy. retifanlimab will be administered as monotherapy or in combination with other immunotherapy or targeted agents.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study. Note for Germany: This excludes individuals who are housed in an institution due to official or court order Women 18 years of age or older (or as applicable per local country requirements).
- •Histologically confirmed diagnosis of advanced or metastatic endometrial cancer with disease progression on or after treatment with at least 1 platinum-containing regimen for advanced or metastatic disease.
- •Groups A, B, and E: Have not been previously treated with a PD-(L)1 inhibitor.
- •Group A only: Tumor tissue tested as MSI-High
- •Group B only: Tumor tissue tested as deficient MMR or an ultra-mutated POLE tumor.
- •Group D only: Tumor tissue tested as having an FGFR 1,2,3 mutation or alteration characterized as per protocol.
- •Group E: Tumor tissue tested as MSS and PD-L1 positive.
- •Group F: Radiological evidence of disease progression on or after prior PD (L)1 therapy and Tumor tissue tested as MSI-H
- •Must have at least 1 measurable tumor lesion per RECIST v1.
- •Willing to provide tumor tissue sample (fresh or archived).
- •ECOG performance status 0 to
- •Willingness to avoid pregnancy.
排除标准
- •Group A, B and E only: Histologically confirmed diagnosis of carcinosarcoma of the uterus.
- •Histologically confirmed diagnosis of sarcoma of the uterus.
- •Has disease eligible for potentially curative treatment.
- •Receipt of anticancer therapy within 28 days of the first administration of study treatment, with the exception of localized radiotherapy.
- •Toxicity of prior therapy that has not recovered to ≤ Grade 1 or baseline unless approved by the medical monitor.
- •Groups C, D and F (combinations): limiting immune-related toxicity during prior checkpoint inhibitor therapy.
- •Group F only: Previous treatment with LAG-# or TIM-3 therapy or lenvatinib; multiple metastases that achieved mixed tumor response to prior anti-PD-(L)1 therapy
- •Has an active autoimmune disease requiring systemic immunosuppression with corticosteroids (> 10 mg/day of prednisone or equivalent) or immunosuppressive drugs within 14 days before the first dose of study treatment.
- •Receiving chronic systemic steroids (> 10 mg/day of prednisone or equivalent):
- •Known active CNS metastases and/or carcinomatous meningitis.
- •Has known active hepatitis B or C.
- •Has received a live vaccine within 28 days of the planned start of study treatment.
- •Evidence of interstitial lung disease or active, noninfectious pneumonitis.
- •Participants who are known to be HIV-positive with some protocol exceptions.
研究组 & 干预措施
Group C - retifanlimab + epacadostat
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
干预措施: epacadostat (Drug)
Group D - retifanlimab + pemigatinib
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
干预措施: pemigatinib (Drug)
Group B - retifanlimab
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
干预措施: retifanlimab (Drug)
Group A - retifanlimab
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously
干预措施: retifanlimab (Drug)
Group C - retifanlimab + epacadostat
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat (IDO1 inhibitor)
干预措施: retifanlimab (Drug)
Group D - retifanlimab + pemigatinib
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral pemigatininb (FGFR 1,2,3 inhibitor)
干预措施: retifanlimab (Drug)
Group E - retifanlimab + epacadostat
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
干预措施: retifanlimab (Drug)
Group E - retifanlimab + epacadostat
Select participants naïve to checkpoint inhibitors will be administered retifanlimab intravenously in combination with oral epacadostat
干预措施: epacadostat (Drug)
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
干预措施: INCAGN02385 (Drug)
Group F - retifanlimab + INCAGN02385 and INCAGN02390
Select participants who are allowed on prior checkpoint inhibitors will be administered retifanlimab in combination with INCAGN02385 and INCAGN02390 intravenously
干预措施: INCAGN02390 (Drug)
结局指标
主要结局
Group A - Objective Response Rate
时间窗: up to 2.5 years
Defined as the proportion of participants having a CR or PR according to RECIST v1.1, as assessed by Independent Central Review committee
次要结局
- Group A -Duration of Response(up to 2.5 years)
- Group A - Disease Control Rate(up to 2.5 years)
- Group A - Overall Survival(up to 3.5 years)
- Group A - Progression Free Survival(up to 3.5 years)
- Group B -Duration of Response(up to 2.5 years)
- Group B - Disease Control Rate(up to 2.5 years)
- Group B - Overall Survival(up to 3.5 years)
- Groups B - Objective Response Rate(up to 2 years)
- Group B - Progression Free Survival(up to 3.5 years)
- Groups C, D, E and F - Objective Response Rate(up to 2 years)
- Number of Treatment-Related Adverse Events(up to 4 years)