Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial 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.
Phase
Phase 2
Funding Agency/Sponsor
Industrial
Disease
Cutaneous Malignancies
Enrollment Eligibility
Key Inclusion Criteria:
- 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.
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.