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Clinical Trial 20562

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

Phase: Phase II
Prinicipal Investigator: Nikhil Khushalani

Call 813-745-6100
or 1-800-679-0775 Learn More

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



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)




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

Inclusion Criteria

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 1 or more
  • Anticipated life expectancy over 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

    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.
  • 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.
  • Other protocol defined Inclusion/Exclusion criteria apply.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.