EUCTR2018-003964-30-FR进行中（未招募）1 期
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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
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 CSCC that is locally advanced or metastatic.
- •3. At least 1 lesion that is measurable and injectable by study criteria (tumor of =1cm in longest
- •diameter or =1.5 cm in shortest diameter for lymph nodes).
- •If a previously radiated lesion is to be followed as a target lesion, progression of that lesion
- •must be confirmed by biopsy after radiation therapy. Previously radiated lesions may be
- •followed as non-target lesions if there is at least 1 other measurable target lesion.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status =1.
- •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 estimated creatinine clearance =30cc/min
- •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. Females of childbearing potential who have a negative serum pregnancy test at screening
- •and urine on Cycle 1 Day 1 prior to dosing.
- •12. Female subjects of childbearing potential who are willing to use a highly effective method
- •of birth control (which must include at least a barrier method) or who are surgically sterile
- •or abstain from heterosexual activity for the course of the study and for 6 months after last
- •dose of study drug.
- •13. Male subjects of reproductive potential who agree to use a highly effective method of
- •contraception during sexual contact with females of childbearing potential (which must
- •include at least a barrier method) starting from the first dose of study drug to 6 months after
- •the last dose of study drug and also agree to abstaining from donating sperm during this
- •14. Screening electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT
- •interval > 440ms.
- •15. Baseline troponin < 0.06 ng/mL.
- •16. Baseline pulse oximetry with pO2 = 92% on room air.
- •17. Locally advanced only: Surgery must be deemed contraindicated in the opinion either a
- •medical oncologist with experience in cutaneous malignancy management or a
- •dermatologist, or a head and neck surgeon, or multi-disciplinary disease management
- •18. Locally advanced only: Patients must be deemed as not appropriate for radiation therapy.
- •This must include the opinion of a radiation oncologist or either a medical oncologist, head
- •and neck surgeon or dermatologist with expertise in cutaneous malignancies, or a multidisciplinary
- •19. All patients must consent to provide archived or newly obtained tumor material (either
- •formalin-fixed,
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).
- •3. Patients who require intermittent or chronic use of systemic (oral or intravenous) 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
- •immune-related adverse events (irAEs) or has 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, or psoriasis
- •that does not require systemic treatment.
- •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 (> 20 mg prednisone daily or equivalent) within
- •4 weeks prior to the first dose of cemiplimab.
- •9. Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus
- •(HCV) or HIV.
- •10. History of interstitial lung disease (ILD)/pneumonitis within the last 5 years or a history of
- •ILD/pneumonitis requiring treatment with systemic steroids.
- •11. 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 dosing.
- •12. Grade = 3 hypercalcemia at time of enrollment.
- •13. Any systemic anticancer treatment (chemotherapy, targeted systemic therapy,
- •photodynamic therapy), investigational or standard of care, within 30 days of the initial
- •administration of RP1 or cemiplimab or planned to occur during the study period (patients receiving bisphosphonates or denosumab are not excluded), radiation therapy within 14
- •days of initial administration of cemiplimab or planned to occur during the study period.
- •14. History of documented allergic reactions or acute hypersensitivity reaction attributed to
- •antibody treatments.
- •15. Patients with allergy or hypersensitivity to RP1 or cemiplimab or to any of the excipients
- •must be excluded. Specifically, because of the presence of trace components in
- •cemiplimab, patients with allergy or hypersensitivity to doxycycline or tetracycline are
- •16. Patients who are breast feeding.
- •17. 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 include: adequately treated BCC of the skin,
- •carcinoma in situ of the cervix, or ductal carcinoma in situ of the breast, or low-risk early
- •stage prostate adenocarcinoma (T1-T2aN0M0 and Gleason score =6 and prostate specific
- •antigen [PSA] =10 ng/mL) for which the man
研究者
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