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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 : Active, not recruiting
First Posted : August 8, 2019
Last Update Posted : February 3, 2023
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Replimune Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Advanced Cutaneous Squamous Cell Carcinoma Metastatic Cutaneous Squamous Cell Carcinoma Drug: Cemiplimab Biological: RP1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 8, 2019
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cemiplimab in combination with RP1
Cemiplimab administered intravenously every 3 weeks in combination with RP1 administered as an intratumoral injection every 3 weeks
 Drug: Cemiplimab
Cemiplimab administered intravenously
Other Name: Libtayo

Biological: RP1
RP1 administered intratumorally
Other Name: Genetically modified herpes simplex type 1 virus
Active Comparator: Cemiplimab
Cemiplimab administered intravenously as a single therapy every 3 weeks
 Drug: Cemiplimab
Cemiplimab administered intravenously
Other Name: Libtayo


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) according to blinded independent review [ Time Frame: up to 5 years ]
  2. Complete Response Rate (CRR) according to blinded independent review [ Time Frame: up to 5 years ]

Secondary Outcome Measures :
  1. Progression Free Survival (PFS) by blinded independent review. [ Time Frame: up to 5 years ]
  2. ORR/CRR by investigator assessment and blinded independent review [ Time Frame: up to 5 years ]
  3. ORR/CRR for patients with metastatic or locally advanced disease according to investigator review and blinded independent review [ Time Frame: up to 5 years ]
  4. 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 ]
  5. Duration of Response (DOR) per investigator review and blinded independent review [ Time Frame: up to 5 years ]
  6. Progression-free Survival (PFS) per investigator review [ Time Frame: up to 5 years ]
  7. Overall Survival (OS) [ Time Frame: up to 5 years ]
  8. 3-year survival [ Time Frame: 3 years ]
  9. 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 ]
  10. Evaluation of the safety and tolerability of cemiplimab alone and combined with RP1 as assessed via adverse events (AEs) [ Time Frame: approximately 26 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050436


Locations
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Sponsors and Collaborators
Replimune Inc.
Regeneron Pharmaceuticals
Investigators
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Study Director: Sumera Raoof, MD Lead Medical Monitor
Study Director: Jeannie Hou, MD Secondary Medical Monitor
More Information
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Responsible Party: Replimune Inc.
ClinicalTrials.gov Identifier: NCT04050436    
Other Study ID Numbers: RPL-002-18
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Replimune Inc.:
Oncolytic Virus
Carcinoma
Carcinoma, Squamous Cell
 Cemiplimab
Metastatic Cutaneous Squamous Cell Carcinoma
Oncolytic Immuno-gene therapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Squamous Cell
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents