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
- Study HIC#:2000026736
- Last Updated:07/15/2021
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.
- Age18 years and older
- Start Date02/25/2021
- End Date10/31/2022
Trial Purpose and Description
Primary Outcome Measures :
- Objective Response Rate (ORR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review [ Time Frame: 36 months ]
Secondary Outcome Measures :
- ORR for patients with metastatic or locally advanced disease [ Time Frame: 36 months ]
- ORR for patients who have and have not previously received systemic CSCC-directed therapy [ Time Frame: 36 months ]
- ORR by investigator assessment [ Time Frame: approximately 36 months ]
- Rate of individual tumor response in injected versus non-injected lesions [ Time Frame: 36 months ]
- Duration of Response (DOR) per central and investigator review [ Time Frame: 36 months ]
- Progression-free Survival (PFS) per central and investigator review [ Time Frame: 36 months ]
- Complete response (CR) rate per central and investigator review [ Time Frame: 36 months ]
- Overall Survival (OS) [ Time Frame: approximately 36 months ]
- Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) [ Time Frame: 36 months ]Overall adverse event rates and adverse event rates per observation period will be compared for the two treatment groups using a two-sided Fisher Exact test. Results will be analyzed by SOC and for preferred terms with >10% overall incidence.
- Change in overall scores of patient-reported outcomes in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: 36 months ]
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.
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.
- Known infection including active infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- History of ILD/pneumonitis within the last 5 years or a history of ILD/pneumonitis requiring treatment with systemic steroids.
Note: Other protocol defined Inclusion/Exclusion criteria apply.