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 sites230 target enrollmentJanuary 26, 2021

ConditionsAdvanced Cutaneous Squamous Cell Carcinoma MedDRA version: 21.1Level: PTClassification code 10077314Term: Skin squamous cell carcinoma metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Advanced Cutaneous Squamous Cell Carcinoma
Sponsor: Replimune, Inc.
Enrollment: 230
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 26, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Replimune, Inc.

Eligibility Criteria

Inclusion Criteria

•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)

Exclusion Criteria

•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 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).
•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 (\> 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.