Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer

Not Recruiting

Trial ID: NCT04050436


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) and complete response rate (CRR) according to blinded independent review.

Official 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

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)


Key Inclusion Criteria:

   - Histologically confirmed locally advanced or metastatic cutaneous squamous cell

   - Patients with locally advanced disease who are not suitable candidates for surgical or
   radiological treatment of lesions or have refused those treatments

   - At least 1 lesion that is measurable and injectable by study criteria

   - Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG PS
   2 at baseline may be allowed to enroll if PS 2 status is only related to the CSCC
   disease under study

   - 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.

Key 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.

   - Acute or chronic active hepatitis B or known history of hepatitis B or hepatitis C or
   human immunodeficiency virus (HIV) infection

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

   - Any major or surgical procedure ≤ 28 days before randomization

   - Administration of live vaccines ≤ 28 days before randomization

Note: Other protocol defined Inclusion/Exclusion criteria apply.


drug: Cemiplimab

biological: RP1

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Elizabeth Winters

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