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Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

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.
 
ClinicalTrials.gov Identifier: NCT02760498
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Advanced Cutaneous Squamous Cell Carcinoma Drug: cemiplimab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 433 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 7, 2016
Estimated Primary Completion Date : October 20, 2025
Estimated Study Completion Date : December 1, 2025

Arm Intervention/treatment
Experimental: Group 1
Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 2 weeks.
Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Experimental: Group 2
Patients with unresectable locally advanced CSCC. Cemiplimab administered intravenously every 2 weeks.
Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Experimental: Group 3
Patients with metastatic CSCC: to distant sites or lymph nodes. Cemiplimab administered intravenously every 3 weeks.
Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Experimental: Group 4
Patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] Cemplimab administered intravenously every 4 weeks.
Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo

Experimental: Group 6
Patients with advanced CSCC (metastatic [nodal or distant] or locally advanced). Cemiplimab administered IV every 3weeks.
Drug: cemiplimab
Other Names:
  • REGN2810
  • Libtayo




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Investigator Assessments of Overall Response Rate [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6

  2. Duration of response [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6

  3. PFS (progression-free survival) [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6

  4. Overall Survival [ Time Frame: Up to 30 months ]
    Groups 1-4 and 6

  5. Complete Response (CR) Rate [ Time Frame: Up to 30 months ]
  6. Change in scores of patient reported outcomes on EORTC QLQ-C30 [ Time Frame: Up to 30 months ]
  7. Incidence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 30 months ]
  8. Cemiplimab PK: Concentration at end-of-infusion (Ceoi) (IV) [ Time Frame: Up to 24 months ]
  9. Cemiplimab PK: Peak concentrations (Cmax) (SC) [ Time Frame: Up to 24 months ]
  10. Cemiplimab PK: Pre-infusion concentration (Ctrough) [ Time Frame: Up to 24 months ]
  11. Cemiplimab PK: Time of end-of-infusion (teoi) [ Time Frame: Up to 24 months ]
  12. Cemiplimab PK: Time to peak concentration (tmax) (SC) [ Time Frame: Up to 24 months ]
  13. Cemiplimab PK: Area under the plasma concentration-time curve after the first SC or IV dose [ Time Frame: Up to 24 months ]
  14. Cemiplimab PK: Absolute bioavailability after SC administration [ Time Frame: Up to 24 months ]
  15. Anti-cemiplimab antibodies [ Time Frame: Up to 30 months ]
  16. Immunohistochemistry (IHC) assessment of correlation between PD-L1 status and ORR [ Time Frame: Up to 30 months ]
    Group 6

  17. IHC assessment of correlation between PD-L1 and DOR [ Time Frame: Up to 30 months ]
    Group 6

  18. IHC assessment of correlation between PD-L1 and PFS [ Time Frame: Up to 30 months ]
    Group 6



Information from the National Library of Medicine

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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:

  • 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


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): NCT02760498


Contacts
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Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02760498    
Other Study ID Numbers: R2810-ONC-1540
2016-000105-36 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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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 Regeneron Pharmaceuticals:
Metastatic CSCC
Unresectable locally advanced CSCC
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