NCT06384820撤回2 期
A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
研究概览
简要总结
This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).
The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.
The study is looking at several other research questions, including:
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
- Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
- What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
- How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)
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
- 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
- •Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
- •Tumor biopsy is required during screening period as described in the protocol
- •Participant is willing to undergo delayed surgery
- •At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and bone marrow function as described in the protocol
排除标准
- •Stage I or II CSCC
- •Anogenital, penile, vermilion lip CSCC
- •CSCC bone invasion
- •Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
- •Prior radiation therapy for CSCC
- •Myocardial infarction within 6 months of enrollment, or history of myocarditis.
- •Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol
- •Note: Other protocol-defined Inclusion/Exclusion Criteria apply
研究组 & 干预措施
cemiplimab
Experimental
干预措施: cemiplimab (Drug)
fianlimab+cemiplimab
Experimental
干预措施: cemiplimab (Drug)
fianlimab+cemiplimab
Experimental
干预措施: fianlimab (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
时间窗: Up to 100 days
次要结局
- pCR rate by local pathological review(Up to 100 days)
- Major pathological response (MPR)(Up to 100 days)
- Event-free survival (EFS)(Up to 3 years)
- Disease free survival (DFS)(Up to 3 years)
- Objective response rate (ORR) prior to surgery(Up to 100 days)
- Occurrence of adverse event of special interest (AESI)(Up to 3 years)
- Occurrence of treatment-emergent serious adverse events (SAEs)(Up to 3 years)
- Titer of ADA to cemiplimab(Up to 3 years)
- Titer of ADA to fianlimab(Up to 3 years)
- Titer of ADA to other experimental agents (as applicable)(Up to 3 years)
- Occurrence of death due to TEAE(Up to 3 years)
- Overall survival (OS)(Up to 3 years)
- Occurrence of immune-mediated adverse events (imAEs)(Up to 3 years)
- Occurrence of treatment-related TEAEs(Up to 3 years)
- Concentrations of other experimental agents (as applicable) in serum(Up to 3 years)
- Incidence of anti-drug antibodies (ADA) to cemiplimab(Up to 3 years)
- Concentrations of fianlimab in serum(Up to 3 years)
- Occurrence of treatment-emergent adverse events (TEAEs)(Up to 3 years)
- Occurrence of interruption of study drug(s) due to TEAEs(Up to 3 years)
- Occurrence of discontinuation of study drug(s) due to TEAEs(Up to 3 years)
- Occurrence of cancellation of surgery due to TEAE(Up to 100 days)
- Occurrence of laboratory abnormalities(Up to 3 years)
- Occurrence of delay to surgery due to TEAE(Up to 100 days)
- Concentrations of cemiplimab in serum(Up to 3 years)
- Incidence of ADA to fianlimab(Up to 3 years)
- Incidence of ADA to other experimental agents (as applicable)(Up to 3 years)
研究者
相似试验
进行中（未招募）
2 期
Cemiplimab in Treating Patients With Recurrent and Resectable Stage II-IV Head and Neck Cutaneous Squamous Cell Cancer Before SurgeryRecurrent Cutaneous Squamous Cell Carcinoma of the Head and NeckResectable Cutaneous Squamous Cell Carcinoma of the Head and NeckStage II Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8NCT03565783M.D. Anderson Cancer Center44
进行中（未招募）
2 期
A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With SurgeryResectable Non-small Cell Lung CancerNCT06161441Regeneron Pharmaceuticals195
已完成
1 期
Intralesional Cemiplimab for Adult Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell CarcinomaCutaneous Squamous Cell CarcinomaBasal Cell CarcinomaNCT03889912Regeneron Pharmaceuticals97
已完成
2 期
Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile CancerPenile CarcinomaNCT04224740Latin American Cooperative Oncology Group37
已完成
2 期
Sintilimab in Cancer of Unknown PrimaryCancer of Unknown Primary SiteNCT05024968M.D. Anderson Cancer Center10