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

• ClinicalTrials.gov Identifier: NCT04050436
• Recruitment Status: Recruiting
• First Posted: August 8, 2019
• Last Update Posted: December 23, 2020
• Sponsor: Replimune Inc.
• Collaborator: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Replimune Inc.

Tracking Information

• First Submitted Date: August 2, 2019
• First Posted Date: August 8, 2019
• Last Update Posted Date: December 23, 2020
• Actual Study Start Date: October 8, 2019
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 21, 2020): Objective Response Rate (ORR) based on modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review [ Time Frame: 36 months ]
• Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Cemiplimab Alone and Combined With RP1 in Treating Advanced Squamous Skin Cancer
• Official Title: 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) according to central review.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cutaneous Squamous Cell Carcinoma
• Advanced Cutaneous Squamous Cell Carcinoma
• Metastatic Cutaneous Squamous Cell Carcinoma

Intervention

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

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 7, 2019): 240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2024
• Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Clinical Trials at Replimune; 1-781-222-9570; Clinicaltrials@replimune.com

• Listed Location Countries: Australia, United States

Administrative Information

• NCT Number: NCT04050436
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Replimune Inc.
• Study Sponsor: Replimune Inc.
• Collaborators: Regeneron Pharmaceuticals

Investigators

• Study Director: Selda Samakoglu, MD, PhD; Senior Medical Director

• PRS Account: Replimune Inc.
• Verification Date: December 2020