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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04050436
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : July 7, 2020
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Replimune Inc.

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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 : October 2022
Estimated Study Completion Date : March 2024

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

Primary Outcome Measures :
  1. Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 according to central review [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. ORR for patients with metastatic or locally advanced disease [ Time Frame: 36 months ]
  2. ORR for patients who have and have not previously received systemic CSCC-directed therapy [ Time Frame: 36 months ]
  3. ORR by investigator assessment [ Time Frame: approximately 36 months ]
  4. Rate of individual tumor response in injected versus non-injected lesions [ Time Frame: 36 months ]
  5. Duration of Response (DOR) per central and investigator review [ Time Frame: 36 months ]
  6. Progression-free Survival (PFS) per central and investigator review [ Time Frame: 36 months ]
  7. Complete response (CR) rate per central and investigator review [ Time Frame: 36 months ]
  8. Overall Survival (OS) [ Time Frame: approximately 36 months ]
  9. 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.

  10. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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.
  • 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.

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 identifier (NCT number): NCT04050436

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Contact: CERPASS Study 781 222-9540

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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Badri Modi, MD         
Chan Soon-Shiong Institute for Medicine Recruiting
El Segundo, California, United States, 90245
Contact: Tara Seery, MD         
University of California San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Mina Nikanjam, MD, PhD         
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90024
Contact: Wanxing Chai-Ho, MD         
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Karl Lewis, MD         
United States, Florida
University of Miami Health System Recruiting
Miami, Florida, United States, 33136
Contact: Jose Lutzky, MD         
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ragini Kudchadkar, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Ann Silk, MD         
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Rekha Chaudhary, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Contact: Rom Leidner, MD         
Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Camperdown, New South Wales, Australia
Contact: Jenny Lee, MD         
Southern Medical Day Care Centre Recruiting
Wollongong, New South Wales, Australia
Contact: Daniel Brungs, MD         
Australia, Queensland
Tasman Oncology Research Ltd Recruiting
Southport, Queensland, Australia
Contact: Andrew Hill, MD         
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Contact: Muhammad Alamgeer, MD         
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia
Contact: Danny Rischin, MD         
The Alfred Recruiting
Melbourne, Victoria, Australia
Contact: Andrew Haydon, MD         
Sponsors and Collaborators
Replimune Inc.
Regeneron Pharmaceuticals
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Study Director: Selda Samakoglu, MD, PhD Senior Medical Director
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Responsible Party: Replimune Inc. Identifier: NCT04050436    
Other Study ID Numbers: RPL-002-18
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: June 2020
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, Squamous Cell
Metastatic Cutaneous Squamous Cell Carcinoma
Oncolytic Immuno-gene therapy
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Antineoplastic Agents, Immunological
Antineoplastic Agents