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