Clinical Trial 20562

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT04050436

Phase: Phase II
Principal Investigator: Khushalani, Nikhil

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Overview

Study Title

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

Summary

To estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic CSCC, as assessed by overall response rate (ORR) according to central review.

Objective

The primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy versus cemiplimab in combination with RP1 for patients with locally advanced or metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), as assessed by overall response rate (ORR) according to central review. The secondary objectives of the study are: To estimate ORR for patients with locally advanced CSCC To estimate ORR for patients with metastatic CSCC To estimate ORR according to investigator review To estimate ORR for patients having previously received systemic CSCC-directed therapy To estimate ORR for patients not having previously received systemic CSCC-directed therapy To estimate the duration of response (DOR) by central and investigator review To estimate progression-free survival (PFS) by central and investigator review To estimate the complete response (CR) rate by central and investigator review To estimate overall survival (OS) To estimate the disease-specific survival (DSS) To estimate the 3 year survival To assess the safety and tolerability of cemiplimab alone and combined with RP1 To assess the change of cemiplimab and cemiplimab combined with RP1 on quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30)

Treatments

Therapies

Immunotherapy; Therapy (NOS)

Medications

Cemiplimab (); REGN2810 (Cemiplimab); RP1 ()

Inclusion Criteria

Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma

Patients for whom surgical or radiological treatment of lesions is contraindicated

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).

Eastern Cooperative Oncology Group (ECOG) performance status > Anticipated life expectancy >12 weeks

All patients must consent to provide archived or newly obtained tumor material for central pathology review for confirmation of diagnosis of CSCC.

Exclusion Criteria

Prior treatment with an oncolytic therapy

Patients with active significant herpetic infections or prior complications of HSV-1 infection (e.g. herpetic keratitis or encephalitis)

Patients who require intermittent or chronic use of systemic (oral or intravenous) anti-virals with known anti-herpetic activity (e.g. acyclovir)

Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments

Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.

Prior treatment with other immune modulating agents other than as adjuvant or neoadjuvant therapy within 3 years.

Untreated brain metastasis(es) that may be considered active.

Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).

History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.

Note: Other protocol defined Inclusion/Exclusion criteria apply.

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