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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 : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
To estimate the clinical benefit of REGN2810 monotherapy for patients with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC) (Groups 1 and 3) or with unresectable locally advanced CSCC (Group 2), as measured by overall response rate (ORR), according to central review.

Condition or disease Intervention/treatment Phase
Advanced Cutaneous Squamous Cell Carcinoma Drug: REGN2810 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 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 : May 11, 2016
Estimated Primary Completion Date : January 13, 2020
Estimated Study Completion Date : June 29, 2020

Arm Intervention/treatment
Experimental: Group 1
Patients with metastatic CSCC: to distant sites or lymph nodes. REGN2810 administered intravenously every 2 weeks.
Drug: REGN2810
Experimental: Group 2
Patients with unresectable locally advanced CSCC. REGN2810 administered intravenously every 2 weeks.
Drug: REGN2810
Experimental: Group 3
Patients with metastatic CSCC: to distant sites or lymph nodes. REGN2810 administered intravenously every 3 weeks.
Drug: REGN2810



Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 96 weeks ]
    Group 1 and Group 3: 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 ]
  2. Duration of response [ Time Frame: Up to 30 months ]
  3. PFS (progression-free survival) [ Time Frame: Up to 30 months ]
  4. Overall Survival [ Time Frame: Up to 30 months ]
  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. REGN2810 PK: Concentration at end-of-infusion (Ceoi) [ Time Frame: Up to 24 months ]
  9. REGN2810 PK: Pre-infusion concentration (trough) [ Time Frame: Up to 24 months ]
  10. REGN2810 PK: Time of end-of-infusion (teoi) [ Time Frame: Up to 24 months ]
  11. Anti-REGN2810 antibodies [ Time Frame: Up to 24 months ]


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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 externally visible CSCC lesions (Group 2 only)
  • 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 REGN2810, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of REGN2810, 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 REGN2810
  • Infection with human immunodeficiency virus (HIV) and/or chronic/active infection with hepatitis B virus or hepatitis C virus
  • History of 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
  • Prior treatment with idelalisib

Other protocol-defined inclusion/exclusion criteria may 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
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

  Show 39 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02760498     History of Changes
Other Study ID Numbers: R2810-ONC-1540
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell