Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
18 Years and older, Male and Female
RPL-002-18 (primary)
NCI-2019-06779
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) and complete response rate (CRR) according to blinded independent review.
Objectives
RP1 is a selectively replication competent herpes simplex virus type 1(HSV-1). This is a
Phase 1/2, open-label, multicenter repeat-dosing study of RP1 alone and in combination with
nivolumab in patients with advanced malignancies, and contains both single agent dose
escalation, dose expansion to include nivolumab, and the combination in multiple Phase 2
cohorts in individual tumor types.
Eligibility
- Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
- 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.
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