2024-512652-38-00
进行中（未招募）
2 期
A Randomized, Controlled, Open-Label, Phase 2 Study of Cemiplimab as a Single Agent and in Combination With RP1 in Patients With Advanced Cutaneous Squamous Cell Carcinoma [CERPASS]
概览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 143
- 试验地点
- 25
- 主要终点
- The primary efficacy endpoints for this study are ORR and CRR according to blinded independent review:
概览
简要总结
The primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or nodal or distant metastatic cutaneous squamous cell carcinoma (CSCC), as assessed by overall response rate (ORR) and complete response rate (CRR) according to blinded independent review.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Voluntary agreement to provide written informed consent and willingness and ability to comply with protocol requirements.
- •ECOG performance status (PS) ≤1 (Appendix 4). Note: Patients with ECOG PS 2 at baseline may be allowed to enroll if PS 2 status is only related to the disease under study (ie, CSCC), and they fulfill all other eligibility criteria, and upon consultation with the medical monitor.
- •Male or female ≥18 years old.
- •Hepatic function: a. Total bilirubin ≤1.5 × upper limit of normal (ULN); (if liver metastases ≤3 × ULN). Patients with Gilbert’s Disease and total bilirubin up to 3 × ULN may be eligible after communication with and approval from the medical monitor b. Transaminases (alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) ≤3 × ULN (or ≤5.0 × ULN, if liver metastases) c. Alkaline phosphatase (ALP) ≤2.5 x ULN (or ≤5.0 x ULN, if liver or bone metastases) Note for patients with hepatic metastases who wish to enroll: If transaminase levels (AST and/or ALT) are >3 × but ≤5 × ULN, total bilirubin must be ≤1.5 × ULN. If total bilirubin is >1.5 × but ≤3 × ULN, both transaminases (AST and ALT) must be ≤3 × ULN.
- •Νεφρική λειτουργία: Κρεατινίνη ορού ≤1,5 × ΑΦΤ Ή, εάν η κρεατινίνη ορού > 1,5 × ΑΦΤ, υπολογιζόμενη κάθαρση κρεατινίνης ≥ 30 mL/min (με Cockcroft).
- •Bone marrow function: a. Hemoglobin ≥9.0 g/dL b. Absolute neutrophil count (ANC) ≥1.5 × 109/L c. Platelet count ≥100 × 109/L
- •Prothrombin time (PT) ≤1.5 × ULN (or international normalized ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤1.5 × ULN. See additional criteria for patients on chronic anticoagulation in the inclusion criteria section of the protocol.
- •Anticipated life expectancy > 12 weeks.
- •Female and male patients of reproductive potential must agree to avoid becoming pregnant or impregnating a partner and adhere to highly effective contraception methods for 6 months after the last dose of cemiplimab or cemiplimab and RP1 combination treatment. In addition, male patients must refrain from donating sperm during this study treatment and for up to 6 months after the last dose of cemiplimab or cemiplimab and RP1 combination treatment. For a definition of highly effective contraceptive methods and instructions of patients and partners, see Section 9.3.4.9
- •Locally advanced CSCC only (Surgery): Patients must be deemed as not appropriate candidates for curative surgery in the opinion of either a medical oncologist with experience in cutaneous malignancy management, a dermatologist, a head and neck surgeon, or a multidisciplinary disease management team, or documented to have refused surgery. See Section 4.2.1 of the protocol for definitions of acceptable contraindications for surgery.
排除标准
- •Prior treatment with an oncolytic therapy.
- •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for ImAEs or a diagnosis of immunodeficiency disorders (such as human immunodeficiency virus [HIV] disease or organ transplantation or hematologic malignancies associated with immune suppression). Note: The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, alopecia areata or psoriasis that does not require systemic treatment.
- •Prior treatment with an agent that blocks the programmed cell death-1 (receptor) (PD-1)/PD-L1 pathway
- •Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years. Examples of immune modulating agents include therapeutic anticancer vaccines, cytokine treatments (other than granulocyte colony-stimulating factor [G-CSF] or erythropoietin), or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), PI 3-K-delta, or OX-
- •Untreated brain metastasis(es) that are considered active. See exclusion criteria in the protocol for exceptions for brain metastases (Section 4.2.2).
- •Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 2 weeks prior to randomization/enrollment. See exclusion criteria in protocol for exceptions for corticosteroids (Section 4.2.2).
- •Patient who has acute or chronic active hepatitis B or known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or hepatitis C virus (defined as HCV RNA [qualitative] or HIV infection. Note: No testing for Hepatitis B, Hepatitis C, or HIV is required unless mandated by local health authority or clinically indicated.
- •History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
- •Patients with allergy or hypersensitivity to RP1’s or cemiplimab’s excipients must be excluded.
- •Female who has a positive serum β-hCG pregnancy (at screening within 72 hours before dosing) and urine pregnancy test (Cycle 1 Day1) or is breast feeding or planning to become pregnant.
结局指标
主要结局
The primary efficacy endpoints for this study are ORR and CRR according to blinded independent review:
The primary efficacy endpoints for this study are ORR and CRR according to blinded independent review:
ORR/CRR will be determined using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST 1.1) as specified in Appendix 1 for radiologically assessable lesions and clinical and composite response criteria as specified in Appendix 2 for clinically assessable lesions. Confirmatory scans should also be obtained ≥4 weeks following initial documentation of objective response or progressive disease (PD).
ORR/CRR will be determined using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (RECIST 1.1) as specified in Appendix 1 for radiologically assessable lesions and clinical and composite response criteria as specified in Appendix 2 for clinically assessable lesions. Confirmatory scans should also be obtained ≥4 weeks following initial documentation of objective response or progressive disease (PD).
In patients suspected of achieving a complete response (CR) by clinical assessment, tumor biopsies may be used in the final determination of CR.
In patients suspected of achieving a complete response (CR) by clinical assessment, tumor biopsies may be used in the final determination of CR.
次要结局
- The key secondary outcome measure is PFS by blinded independent review.
- ORR/CRR by investigator review
- ORR/CRR for patients with metastatic (nodal or distant) disease by investigator and BIRC review
- ORR/CRR for patients with locally advanced disease by investigator and blinded independent review
- ORR/CRR for patients having previously received systemic CSCC-directed therapy by investigator and blinded independent review
- ORR/CRR for patients not having previously received systemic CSCC-directed therapy by investigator and blinded independent review
- DOR by investigator and blinded independent review
- PFS by investigator review
- OS
- 3-year survival
- Change in scores of patient-reported outcomes on EORTC QLQ-C30
- To assess the safety and tolerability of cemiplimab alone and combined with RP1
研究者
Kari Jeschke, SVP Regulatory Affairs
Scientific
Replimune Group Inc.
研究点 (25)
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