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

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.

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).
• 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.
• Untreated brain metastasis(es) that may be considered active.
• 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.
Phase II
Oral, Head and Neck
Rom Leidner, M.D.
Replimune Inc.
George Morris
  • Providence Cancer Institute Franz Clinic