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Trial record 22 of 41 for:    cemiplimab

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 : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
To estimate the clinical benefit of cemiplimab 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), or with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated (Group 4) as measured by overall response rate (ORR), according to central review.

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 : 266 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 : February 26, 2020
Estimated Study Completion Date : August 11, 2021

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 Name: REGN2810

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

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

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




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 42 months ]
    Groups 1, 3, and 4: RECIST version 1.1 will be used to determine ORR. Groups 2 and 4: 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. 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 (trough) [ 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 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 CSCC lesions (Groups 2 and 4 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 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

  Hide Study Locations
Locations
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United States, Arizona
University of Arizona Cancer Center Active, not recruiting
Phoenix, Arizona, United States, 85004
Mayo Clinic Completed
Phoenix, Arizona, United States, 85054
United States, California
City of Hope Hospital Active, not recruiting
Duarte, California, United States, 91010
University of California, Los Angeles Active, not recruiting
Los Angeles, California, United States, 90095
Stanford University Active, not recruiting
Redwood City, California, United States, 94063
University of California, San Diego Active, not recruiting
San Diego, California, United States, 92161
United States, Colorado
University of Colorado, Denver Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Florida
Mount Sinai Comprehensive Cancer Center Active, not recruiting
Miami Beach, Florida, United States, 33140
H. Lee Moffitt Cancer Center Active, not recruiting
Tampa, Florida, United States, 33612
United States, Illinois
Northwestern University Active, not recruiting
Chicago, Illinois, United States, 60611
United States, Kentucky
Norton Cancer Institute Active, not recruiting
Louisville, Kentucky, United States, 40202
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute Active, not recruiting
Boston, Massachusetts, United States, 02130
United States, Michigan
Barbara Ann Karmanos Cancer Institute Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
St. Louis University Completed
Saint Louis, Missouri, United States, 63104
Washington University in St. Louis Active, not recruiting
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Nebraska Methodist Hospital Active, not recruiting
Omaha, Nebraska, United States, 68114
United States, New York
New York University Active, not recruiting
New York, New York, United States, 10016
Memorial Sloan Kettering Cancer Center Active, not recruiting
New York, New York, United States, 10021
University of Rochester Medical Center Active, not recruiting
Rochester, New York, United States, 14623
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
St. Luke's Hematology Oncology Specialists Active, not recruiting
Easton, Pennsylvania, United States, 18015
Penn State Hershey Medical Center Completed
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Dermatology and Laser Center of Charleston Active, not recruiting
Charleston, South Carolina, United States, 29407
United States, Texas
MD Anderson Cancer Center Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute Active, not recruiting
Salt Lake City, Utah, United States, 84112
Australia, New South Wales
Royal North Shore Hospital Recruiting
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Royal Brisbane & Women's Hospital Recruiting
Herston, Queensland, Australia, 4029
Australia, South Australia
Adelaide Cancer Centre Recruiting
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
France
Hopital Avicenne Not yet recruiting
Bobigny, France, 93000
Hôpital Saint-André Recruiting
Bordeaux, France, 33000
CHU Dijon Bourgogne Not yet recruiting
Dijon, France, 21079
CHRU Grenoble Not yet recruiting
Grenoble, France, 38043
Centre Hospitalier Universitaire de Nantes Recruiting
Nantes, France, 44093
Hopital Cochin Not yet recruiting
Paris, France, 75014
Hôpital Saint Louis Recruiting
Paris, France, 75475
Centre Hospitalier Lyon Sud Not yet recruiting
Pierre Bénite, France, 69495
Hôpital Robert Debré Not yet recruiting
Reims, France, 51092
Germany
Universitätsklinikum Tübingen Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
LMU Klinikum der Universität München Recruiting
Munich, Bayern, Germany, 80337
Medizinische Hochschule Hannover Recruiting
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Essen Recruiting
Essen, Nordrhein-Westfalen, Germany, 45147
Universitätsklinikum Carl Gustav Carus Recruiting
Dresden, Sachsen, Germany, 01307
Universitatsklinikum Schleswig-Holstein Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Charitè Campus Mitte Recruiting
Berlin, Germany, 10117
SRH Wald-Klinikum Gera Recruiting
Gera, Germany, 07548
Spain
Hospital Universitario Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Hospital Universitario Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
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     History of Changes
Other Study ID Numbers: R2810-ONC-1540
2016-000105-36 ( EudraCT Number )
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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