NCT07808515尚未招募2 期
Phase 2 Platform Trial of Combination Therapies for Participants With Locally Advanced Basal Cell Carcinoma: Master Protocol With Cemiplimab Monotherapy as Comparator Arm
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 135
- 主要终点
- Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria
研究概览
简要总结
This study will test an experimental Regeneron drug called cemiplimab ("study drug") given alone or in combination with other anti-cancer drugs ("combination treatment") to see if they can help treat laBCC.
The study is looking at:
- What side effects cemiplimab, alone or in a combination treatment, might cause
- How well cemiplimab, alone or in a combination treatment, works
- How cemiplimab, alone or in a combination treatment could affect the immune system, which can help researchers understand why cemiplimab, alone or in a combination treatment, works better in some participants than others
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
- •Histologic confirmation of BCC by local board-certified pathologist, as described in the protocol
- •At least one lesion that is measurable by study criteria, defined as ≥ 1cm in at least one dimension, as assessed by radiology and/or digital medical photography, as described in the protocol
- •The treating physician must document that the participant is not appropriate for curative-intent surgery or curative-intent radiation
- •The treating physician must document that the participant does not wish to receive a hedgehog pathway inhibitor (HHI) or is not a candidate for an HHI
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- •Subsequent Therapy Arm - specific inclusion criteria:
- •Documentation of histopathologic diagnosis of basal cell carcinoma - NOT necessary
- •Submission of tumor or blood for exploratory correlative research - NOT necessary
排除标准
- •Metastatic disease to lymph node(s) or distant site(s) (Note: involvement of lymph node due to direct invasion from overlying cutaneous BCC is still considered laBCC, and is not excluded)
- •History or current evidence of significant cardiovascular disease, as described in the protocol
- •Exposure to any prior systemic therapy (eg, HHI or an immune checkpoint inhibitor) or locally injectable agent for laBCC, as described in the protocol
- •Current participation OR past participation in another investigational trial in which an investigational intervention (eg, drug, vaccine, invasive device) was administered within 4 weeks before planned first dose of study intervention in this clinical trial.
- •Subsequent Therapy Arm - specific exclusion criteria:
- •1. Receipt of any anti-cancer therapy (including HHIs, radiation, surgery, or other systemic therapy) for BCC, AFTER treatment on Arms A, B, or C.
- •NOTE: Other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm C
Experimental
干预措施: Fianlimab (Drug)
Subsequent Therapy Arm
Experimental
干预措施: Fianlimab (Drug)
Arm C
Experimental
干预措施: Cemiplimab (Drug)
Subsequent Therapy Arm
Experimental
干预措施: Cemiplimab (Drug)
Subsequent Therapy Arm
Experimental
干预措施: Vidutolimod (Drug)
Arm A
Experimental
干预措施: Cemiplimab (Drug)
Arm B
Experimental
干预措施: Cemiplimab (Drug)
Arm B
Experimental
干预措施: Vidutolimod (Drug)
结局指标
主要结局
Objective Response Rate (ORR) by blinded independent central review (BICR) per Composite Response Criteria
时间窗: Up to approximately 3 years
Composite Response Criteria integrates radiology findings \[Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\] and external lesion assessments from digital photography \[modified World Health Organization (WHO) criteria\].
次要结局
- Duration of Response (DOR) by BICR per Composite Response Criteria(Up to approximately 3 years)
- Time to Response (TTR) by BICR per Composite Response Criteria(Up to approximately 3 years)
- Best Overall Response (BOR) of Complete Response (CR) by BICR per composite Response Criteria(Up to approximately 3 years)
- Progression-Free Survival (PFS) by BICR per Composite Response Criteria(Up to approximately 3 years)
- DOR by investigator review per Composite Response Criteria(Up to approximately 3 years)
- TTR by investigator review per Composite Response Criteria(Up to approximately 3 years)
- Objective Response by investigator review per Composite Response Criteria(Up to approximately 3 years)
- Complete Response (CR) by investigator review per Composite Response Criteria(Up to approximately 3 years)
- PFS by investigator review per Composite Response Criteria(Up to approximately 3 years)
- Occurrence of Treatment-Emergent Adverse Events (TEAEs)(Up to approximately 3 years)
- Severity of TEAEs(Up to approximately 3 years)
研究者
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