NCT06205836招募中2 期
Evaluating a Surgical-Sparing Approach Using Cemiplimab With or Without Fianlimab to Treat Older Patients With Localized or Locally Advanced MSI-H Colorectal Cancer
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年6月13日最近更新:
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
- 44
- 试验地点
- 1
- 主要终点
- Complete Response Rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and clinical activity of cemiplimab and the combination of cemiplimab/fianlimab in microsatellite unstable localized or locally advanced colorectal cancer diagnosed in patients age 70 or greater or in patients age 18 or greater considered poor candidates for surgery or unwilling to undergo surgery.
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
- •for Cohort A and B:
- •Age ≥70 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -2
- •Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
- •Must not have received any prior systemic treatment or radiation.
- •Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
- •Patient's acceptance to have a tumor biopsy.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- •LVEF assessment with documented LVEF ≥ 45% by either TTE or MUGA (TTE preferred) within 6 months from first study drug administration.
- •For both Women and Men, must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
- •Inclusion Criteria for Cohort C and D:
- •Age ≥18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 -
- •Have histologically proven localized or locally advanced mismatch repair deficient (dMMR) or microsatellite unstable (MSI-H) colorectal cancer.
- •Patient deemed a poor surgical candidate after evaluation by a surgeon or unwilling to undergo surgery.
- •Must not have received any prior systemic treatment or radiation.
- •Must be agreeable to endoscopic, and CT surveillance for a total of 24 months.
- •Patient's acceptance to have a tumor biopsy.
- •Patients must have adequate organ and marrow function defined by study-specified laboratory tests and procedures.
- •For both Women and Men, must use acceptable form of birth control while on study.
- •Ability to understand and willingness to sign a written informed consent document.
排除标准
- •for Cohorts A and B:
- •Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- •Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •Have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc.).
- •History of prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, or anti-Lag-3 antibodies for any reason in the 5 years proceeding their colorectal cancer diagnosis.
- •Currently using any chronic systemic steroids.
- •Patient has received a live vaccine within 30 days of the first dose of study drug.
- •History of severe hypersensitivity reaction to any monoclonal antibody.
- •Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Active autoimmune disease.
- •Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- •Patient has a pulse oximetry of <92% on room air.
- •Patient is on supplemental home oxygen.
- •Has clinically significant heart disease.
- •Cohort B Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
- •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
- •Unwilling or unable to follow the study schedule for any reason
- •Exclusion for Cohort C and D:
- •Have received an investigational agent or used an investigational device within 28 days of the first dose of study drug.
- •Have expected to require any other form of systemic or localized antineoplastic therapy while on study.
- •Currently using any chronic systemic steroids.
- •Patient has received a live vaccine within 30 days of the first dose of study drug.
- •History of severe hypersensitivity reaction to any monoclonal antibody.
- •Any tissue or organ allograft, regardless of need for immunosuppression, including corneal allograft.
- •Patient is pregnant or breastfeeding.
- •Cohort D Only: Troponin T (TnT) or troponin I (TnI) > 2x institutional ULN at baseline.
- •Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures.
- •Participation deemed not in the best interest of the patient.
- •Unwilling or unable to follow the study schedule for any reason.
研究组 & 干预措施
Cohort D - Cemiplimab with Fianlimab
Experimental
干预措施: Cemiplimab (Drug)
Cohort D - Cemiplimab with Fianlimab
Experimental
干预措施: Fianlimab (Drug)
Cohort A - Cemiplimab
Experimental
干预措施: Cemiplimab (Drug)
Cohort B - Cemiplimab with Fianlimab
Experimental
干预措施: Cemiplimab (Drug)
Cohort B - Cemiplimab with Fianlimab
Experimental
干预措施: Fianlimab (Drug)
Cohort C - Cemiplimab
Experimental
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Complete Response Rate
时间窗: 6 Months
Proportion of subjects with either a pathologic complete response (pCR) at the time of surgery OR a clinical complete response (cCR) at 6 months for those subjects who do not undergo surgery. pCR is defined as subjects with no viable tumor cell noted on pathological evaluation of the resection specimen. cCR is defined as an absence of visible disease on CT imaging by RECIST 1.1 and endoscopic evaluation.
次要结局
- Number of participants experiencing grade 3 or above drug-related toxicities requiring treatment discontinuation(7 Months)
研究者
研究点 (1)
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