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

Replimune, Inc.0 sites240 target enrollmentNovember 25, 2019

Overview

No summary available.

Registry

who.int

Start Date

November 25, 2019

End Date

TBD

Last Updated

5 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 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:

•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).