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

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ClinicalTrials.gov Identifier: NCT04050436
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : July 21, 2022
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Replimune Inc.

Tracking Information
First Submitted Date  ICMJE August 2, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date July 21, 2022
Actual Study Start Date  ICMJE October 8, 2019
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
  • Objective Response Rate (ORR) according to blinded independent review [ Time Frame: up to 5 years ]
  • Complete Response Rate (CRR) according to blinded independent review [ Time Frame: up to 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2019)		 Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review [ Time Frame: 36 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2021)
  • Progression Free Survival (PFS) by blinded independent review. [ Time Frame: up to 5 years ]
  • ORR/CRR by investigator assessment and blinded independent review [ Time Frame: up to 5 years ]
  • ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review [ Time Frame: up to 5 years ]
  • ORR/CRR for patients who have and have not previously received systemic CSCC-directed therapy and blinded independent review [ Time Frame: up to 5 years ]
  • Duration of Response (DOR) per investigator review and blinded independent review [ Time Frame: up to 5 years ]
  • Progression-free Survival (PFS) per investigator review [ Time Frame: up to 5 years ]
  • Overall Survival (OS) [ Time Frame: up to 5 years ]
  • 3-year survival [ Time Frame: 3 years ]
  • 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: approximately 30 months ]
  • Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) [ Time Frame: approximately 26 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2019)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cutaneous Squamous Cell Carcinoma
  • Advanced Cutaneous Squamous Cell Carcinoma
  • Metastatic Cutaneous Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Cemiplimab
    Cemiplimab administered intravenously
    Other Name: Libtayo
  • Biological: RP1
    RP1 administered intratumorally
    Other Name: Genetically modified herpes simplex type 1 virus
Study Arms  ICMJE
  • Experimental: Cemiplimab in combination with RP1
    Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
    Interventions:
    • Drug: Cemiplimab
    • Biological: RP1
  • Active Comparator: Cemiplimab
    Cemiplimab administered intravenously as a single therapy every 3 weeks
    Intervention: Drug: Cemiplimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2021)		 180
Original Estimated Enrollment  ICMJE
 (submitted: August 7, 2019)		 240
Estimated Study Completion Date  ICMJE March 2025
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials at Replimune 1-781-222-9570 Clinicaltrials@replimune.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   France,   Germany,   Greece,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050436
Other Study ID Numbers  ICMJE RPL-002-18
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Replimune Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Replimune Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Regeneron Pharmaceuticals
Investigators  ICMJE
Study Director: Sumera Raoof, MD Lead Medical Monitor
Study Director: Jeannie Hou, MD Secondary Medical Monitor
PRS Account Replimune Inc.
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP