A Randomized, Controlled, Open-label, Phase 2 Study of Cemiplimab as aSingle Agent and in Combination with RP1 in Patients with AdvancedCutaneous Squamous Cell Carcinoma [CERPASS]

Replimune, Inc.0 个研究点目标入组 230 人开始时间: 2021年10月18日最近更新: 2023年1月9日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Replimune, Inc.
入组人数: 230

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Voluntary agreement to provide written informed consent and willingness and ability to comply with protocol requirements.
•2. Histologically confirmed diagnosis of locally advanced or metastatic (nodal or distant) CSCC by local pathology report. Metastatic (nodal or distant) disease is defined as disseminated disease distant to the initial/primary site of diagnosis. The locally recurrent disease is defined as previously treated disease (with either surgery, radiotherapy, or systemic therapy) and is not amenable to either curative surgery, radiotherapy, or concurrent chemoradiotherapy treatment.
•3. At least 1 measurable lesion and lesion(s) that are injectable, which individually or in aggregate meet the measurable criteria. There is no minimum tumor size for injection, provided there are injectable tumors that are in the aggregate of = 1 cm at baseline.
•4. Eastern Cooperative Oncology Group (ECOG) performance status =1 (Appendix 4).
•5. Male or female =18 years old.
•6. Hepatic function:
•a. Total bilirubin =1.5 x upper limit of normal (ULN); (if liver metastases =3 x ULN). Patients with Gilbert's Disease and total bilirubin up to 3 x ULN may be eligible after communication with and approval from the medical monitor.
•b. Transaminases (ALT or AST) =3 x ULN (or =5.0 x 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 x but =5 x ULN, total bilirubin must be =1.5 x ULN. If total bilirubin is >1.5 x but =3 x ULN, both transaminases (AST and ALT) must be =3 x ULN.
•7. Renal function: Serum creatinine =1.5 x ULN OR, If serum creatinine >1.5xULN. calculated creatinine clearance =30mL/min (using Cockcroft).
•8. Bone marrow function:
•a. Hemoglobin =9.0 g/dL
•b. Absolute neutrophil count (ANC) =1.5 x 109/L
•c. Platelet count =100 x 109/L
•9. Prothrombin time (PT) = 1.5 x ULN (or international normalization ratio [INR] = 1.3) and partial thromboplastin time (PTT) or activated PTT (aPTT) = 1.5 x ULN.
•10. Anticipated life expectancy >12 weeks.
•11. 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
•12 . Locally advanced CSCC only (Surgery): 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 multi-disciplinary disease management team, or documented to have refused surgery.
•13 . Locally advanced CSCC only (Radiotherapy): Patients must be deemed as not appropriate candidates for curative radiation therapy or documented as having refused radiotherapy despite consultation. This must include the opinion of either a radiation oncologist, a medical oncologist, a head and neck surgeon, a dermatologist with expertise in cutaneous malignancies, or a multidisciplinary team.
•14. All patients must consent to provide archived (within

排除标准

•1. Prior treatment with an oncolytic therapy.
•2. Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis or disseminated herpes infection).
•3. Patients who require intermittent or chronic use of systemic (oral or IV) anti-virals with known anti-herpetic activity (e.g. acyclovir).
•4. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immunemediated adverse events (imAEs) or has a diagnosis of immunodeficiency disorders (such as human immunodeficiency virus (HIV) disease or organ transplantation or hematologic malignancies associated with immune suppression).
•5. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
•6. Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years. Examples of immune modulating agents include therapeutic anti-cancer vaccines, cytokine treatments (other than G-CSF or erythropoietin), or agents that target CTLA-4, 4-1BB (CD137), PI 3-K-delta, or OX-40.
•7. Untreated brain metastasis(es) that may be considered active.
•8. Immunosuppressive corticosteroid doses (> 10 mg prednisone daily or equivalent) within 2 weeks prior to randomisation/ enrollment.
•9. 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) or HIV infection.
•10. Active infection requiring systemic therapy within 14 days prior to randomisation/enrollment.
•11. History of interstitial lung disease (ILD)/pneumonitis within the last
•5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
•12. History of myocarditis or congestive heart failure (as defined by the New York Heart Association Functional Classification III or IV), or unstable angina,
•serious uncontrolled cardiac arrhythmia, uncontrolled infection or myocardial infarction within 6 months of randomisation.
•13. Grade = 3 hypercalcemia at time of enrollment.
•14. Any systemic anticancer treatment (chemotherapy, targeted systemic therapy, photodynamic therapy), investigational or standard of care, within 28 days of randomisation/enrollment or planned to occur during the study period (patients receiving bisphosphonates or denosumab are not excluded). Radiation therapy within 14 days of randomisation/enrollment or planned to occur during the study period. Any major surgical procedure = 28 days before randomization. Patients must have recovered adequately from the toxicity and/or complications from prior interventions prior to randomization/enrollment.
•15. Was administered a live vaccine = 28 days before randomisation.
•16. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
•17. Patients with allergy or hypersensitivity to RP1 or cemiplimab's excipients must be excluded.
•18. Female who has a positive serum ß-hCG pregnancy (at screening = 72 hours prior to first study treatment) and urine pregnancy test (Cycle 1 Day 1) or is breast feeding or planning to become pregnant.
•19. Concurrent malignancy other than CSCC and/or history of malignancy other than CSCC within 3 years of date of first planned dose of cemiplimab, except for tumors with negligible risk of metastasis or death. Examples are provided in Section 4.2.2. of the study pr

研究者

发起方

Replimune, Inc.

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