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 sites180 target enrollmentSeptember 2, 2021

Overview

No summary available.

Registry

who.int

Start Date

September 2, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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)

•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