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] - CERPASS

Replimune, Inc.0 个研究点目标入组 180 人开始时间: 2021年9月2日最近更新: 2024年3月18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: 180

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

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. 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 effect 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 multidisciplinary disease management team, or documented to have refused surgery despite consultation.
•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 12 months [6 months preferred] of screening date)

排除标准

•1.Prior treatm with an oncolytic therap
•2.Pt with active significant herpetic infections or prior complications of HSV-1infection(e.g.herpetic keratitis or encephalitis or disseminated herpes infection)
•3.Pt who require intermittent or chronic use of systemic(oral or IV)anti-virals with known antiherpetic activity(e.g.acyclovir)
•4.Ongoing or recent(within5y) evidence of significant autoimmune disease that required treatm with systemic immunosuppressive treatms,which may suggest risk for imAE or has a diagnosis of immunodeficiency disorders(such as HIV disease or organ transplantation or hematologic malignancies associated with immune suppression)
•5.Prior treatm with an agent that blocks thePD-1/PD-L1pathway
•6.Prior treatm with other immune modulating agents other than as adjuvant or neoadjuvant therapy within3y.Examples of immune modulating agents include therapeutic anti-cancer vaccines,cytokine treatms(other than G-CSFor erythropoietin),or agents that targetCTLA-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(>10mg prednisone daily or equivalent)within2w prior to randomisation
•9.Pt who has acute or chronic active hepatitisB or known history of hepatitisB(defined as hepatitisB surface antigen[HBsAg]reactive)or HCV or HIV infection
•10.Active infection requiring systemic therapy with14dd prior to randomisation
•11.History of interstitial lung disease(ILD)/pneumonitis within the last 5y or a history of ILD/pneumonitis requiring treatm with systemic steroids
•12.History of myocarditis or congestive heart failure(as defined by the NYHA Classification III or IV),or unstable angina,serious uncontrolled cardiac arrhythmia,uncontrolled infection or myocardial infarction within 6 months of randomisation
•13.Grade>=3hypercalcemia at time of enrollment
•14.Any systemic anticancer treatm(chemotherapy,targeted systemic therapy,photodynamic therapy),investigational or standard of care, within 28dd of randomisation or planned to occur during the study period(Pt receiving bisphosphonates or denosumab are not excluded).Radiation therapy within14dd of randomisation or planned to occur during the study period.Any major surgical procedure <=28dd before randomization.Pt must have recovered adequately from the toxicity and/or complications from prior interventions prior to randomization
•15.Was administered a live vaccine<=28dd before randomisation
•16.History of documented allergic reactions or acute hypersensitivity reaction attributed to ab treatms
•17.Pt with allergy or hypersensitivity toRP1or cemiplimab's excipients must be excluded.Specifically,cause of the presence of trace components in cemiplimab,Pt with allergy or hypersensitivity to doxycycline or tetracycline are exclud
•18.Female who has a positive serumß-hCG pregnancy(at screening<=72h prior to first study treatm)and urine pregnancy test(Cycle1Day1)or is breast feeding or planning to become pregnant
•19.Concurrent malignancy other thanCSCCand/or history of malignancy other thanCSCC within 3y 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 protocol
•20.Any acute or chronic psychiatric problems or substance abuse disorders that in the opinion of the investigator,would interfer with the pt cooperating with the requirements of the study
•21.Any medical co-morbidity,physical examination finding,or metabolic

研究者

发起方

Replimune, Inc.

相似试验

进行中（未招募）

1 期

A study evaluating the clinical benefit of Cemiplimab versus Cemiplimab in combination with RP1 in patients with skin cancerAdvanced Cutaneous Squamous Cell CarcinomaMedDRA version: 21.1Level: PTClassification code 10077314Term: Skin squamous cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2018-003964-30-PLReplimune, Inc.230

进行中（未招募）

1 期

EUCTR2018-003964-30-GRReplimune, Inc.230

进行中（未招募）

1 期

EUCTR2018-003964-30-FRReplimune, Inc.240

进行中（未招募）

1 期

EUCTR2018-003964-30-BGReplimune, Inc.230

进行中（未招募）

1 期

A Clinical Study to Compare the Effectiveness and Safety of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy

EUCTR2019-003117-33-ITMILLENNIUM PHARMACEUTICALS, INC.150