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

About

Brief 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
  • 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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Study Stats
Protocol No.
20-000301
Category
Hematology-Oncology
Oncology
Contact
Wanxing Chai-Ho
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04050436
For detailed technical eligibility, visit ClinicalTrials.gov.