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

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 [CERPASS]

  • Clinical Trial Information

    Trial Contact: Frankos, Marie

    Trial Phone: 321.841.7303

  • IRB No: W20.185.10

    Protocol Abbrev: The CERPASS Study

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: RPL-002-18

    Treatment: Drug: Cemiplimab Cemiplimab administered intravenously Other Name: Libtayo Biological: RP1 RP1 administered intratumorally Other Name: Genetically modified herpes simplex type 1 virus

    Therapies Involved: Oncology: 1st line

    ClinicalTrials.gov ID: NCT04050436

  • Objective

    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) according to central review.

  • Key Eligibility

    Key Inclusion Criteria:
    •  Histologically confirmed locally advanced or metastatic cutaneous squamous cell carcinoma
    •  Patients for whom surgical or radiological treatment of lesions is contraindicated
    •  At least 1 lesion that is measurable and injectable by study criteria (tumor of ≥1cm in longest diameter or ≥1.5 cm in shortest diameter for lymph nodes).
    •  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.