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Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT02760498
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 8, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date January 26, 2021
Actual Study Start Date  ICMJE April 7, 2016
Estimated Primary Completion Date October 20, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
Overall Response Rate [ Time Frame: 30 months ]
Groups 1, 3, 4, and 6: RECIST version 1.1 will be used to determine ORR. Group 2: Clinical response criteria will be used to determine ORR
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
Overall Response Rate [ Time Frame: During the 12 treatment cycles (96 weeks) ]
Overall Response Rate as determined by RECIST 1.1 for Group 1 and/or assessed per composite response criteria (Group 2)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • Investigator Assessments of Overall Response Rate [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6
  • Duration of response [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6
  • PFS (progression-free survival) [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6
  • Overall Survival [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6
  • Complete Response (CR) Rate [ Time Frame: Up to 30 months ]
  • Change in scores of patient reported outcomes on EORTC QLQ-C30 [ Time Frame: Up to 30 months ]
  • Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 months ]
  • Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV) [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Peak concentrations (Cmax) (SC) [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Pre-infusion concentration (Ctrough) [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Time of end-of-infusion (teoi) [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Time to peak concentration (tmax) (SC) [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose [ Time Frame: Up to 24 months ]
  • Cemiplimab PK: Absolute bioavailability after SC administration [ Time Frame: Up to 24 months ]
  • Anti-cemiplimab antibodies [ Time Frame: Up to 30 months ]
  • Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR [ Time Frame: Up to 30 months ]
    Group 6
  • IHC assessment of correlation between PD-L1 and DOR [ Time Frame: Up to 30 months ]
    Group 6
  • IHC assessment of correlation between PD-L1 and PFS [ Time Frame: Up to 30 months ]
    Group 6
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2016)
  • Duration of response [ Time Frame: From date of treatment until date of first documented progression or date of death, assessed up to 30 months ]
  • PFS (progression-free survival) [ Time Frame: From date of treatment until date of death, assessed up to 30 months ]
  • Overall Survival [ Time Frame: From date of treatment until date of death, assessed up to 30 months ]
  • Change in scores of patient reported outcomes on EORTC QLQ-C30 [ Time Frame: From date of treatment until date of first documented progression or date of death, assessed up to 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Official Title  ICMJE A Phase 2 Study of REGN2810, a Fully Human Monoclonal Antibody to Programmed Death-1 (PD-1), in Patients With Advanced Cutaneous Squamous Cell Carcinoma
Brief Summary For Groups 1 to 4, the primary objective of this study is to estimate the clinical benefit of cemiplimab monotherapy for patients with: metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC. For Group 6, the primary objective is to provide additional efficacy and safety data for cemiplimab monotherapy in patients with advanced CSCC (metastatic [nodal or distant] or locally advanced. Clinical benefit is measured by overall response rate (ORR) according to central review in each group.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cutaneous Squamous Cell Carcinoma
Intervention  ICMJE Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo
Study Arms  ICMJE
  • Experimental: Group 1
    Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 2 weeks.
    Intervention: Drug: cemiplimab
  • Experimental: Group 2
    Patients with unresectable locally advanced CSCC. Cemiplimab administered intravenously every 2 weeks.
    Intervention: Drug: cemiplimab
  • Experimental: Group 3
    Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 3 weeks.
    Intervention: Drug: cemiplimab
  • Experimental: Group 4
    Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered intravenously every 4 weeks.
    Intervention: Drug: cemiplimab
  • Experimental: Group 6
    Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced). Cemiplimab administered IV every 3weeks.
    Intervention: Drug: cemiplimab
Publications *

*   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 18, 2020)
433
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2016)
129
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date October 20, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • At least 1 measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • Archived or newly obtained tumor material
  • Patients must consent to undergo biopsies of CSCC lesions (Groups 2, 4 and 6)
  • Surgical or radiological treatment of lesions contraindicated

Key Exclusion Criteria:

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
  • Prior treatment with an agent that blocks the PD-1/PD-L1pathway
  • Prior treatment with a BRAF inhibitor
  • Prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. Examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic T-lymphocyte antigen 4 (CTLA-4), 4-1BB (CD137), or OX-40.
  • Untreated brain metastasis(es) that may be considered active
  • Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab
  • Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  • History of non-infectious pneumonitis within the last 5 years
  • Allergic reactions or acute hypersensitivity reaction attributed to antibody treatments
  • Known allergy to doxycycline or tetracycline
  • Patients with a history of solid organ transplant
  • Any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable

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 Administrator clinicaltrials@regeneron.com
Listed Location Countries  ICMJE Australia,   Brazil,   France,   Germany,   Greece,   Italy,   New Zealand,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02760498
Other Study ID Numbers  ICMJE R2810-ONC-1540
2016-000105-36 ( EudraCT Number )
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 Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date November 2020

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