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
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Sponsor:
Replimune Inc.
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Replimune Inc.
Tracking Information | |||||||
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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 |
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Original Primary Outcome Measures ICMJE |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
180 | ||||||
Original Estimated Enrollment ICMJE |
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:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |
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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 |