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Pre-Operative Cemiplimab Administered Intralesionally for Patients With Recurrent 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: NCT03889912
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : September 17, 2020
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with recurrent CSCC.

The secondary objectives of this study are:

  • To describe the objective response rate (ORR) in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC, according to modified World Health Organization (WHO) criteria
  • To describe the pathologic complete response (CR) rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To describe the major pathologic response rate in CSCC index lesions following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with recurrent CSCC
  • To assess the immunogenicity of cemiplimab in patients with recurrent CSCC
  • To establish a recommended dose of intralesional cemiplimab for further study in patients with recurrent CSCC

Condition or disease Intervention/treatment Phase
Cutaneous Squamous Cell Carcinoma Drug: Cemiplimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Recurrent Cutaneous Squamous Cell Carcinoma (CSCC)
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : February 23, 2022
Estimated Study Completion Date : February 23, 2022

Arm Intervention/treatment
Experimental: Cemiplimab
Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion
Drug: Cemiplimab
Each patient will receive intralesional injections of cemiplimab every week (QW) into the lesion at the assigned dose level for 12 weeks prior to scheduled surgery
Other Names:
  • REGN2810
  • Libtayo




Primary Outcome Measures :
  1. Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 [ Time Frame: From the first dose through day 28 ]
  2. Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5 [ Time Frame: From the first dose through day 28 ]
  3. Incidence and severity of TEAEs graded according to the NCI CTCAE v5 [ Time Frame: Up to 9 months ]
  4. The incidence and severity of injection site reactions (ISRs) [ Time Frame: From the first dose to 90 days after the last dose ]

Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: Day 85 ]
    Determined by the investigator using the modified WHO criteria at the end of treatment for patients who complete planned 12-week treatment course

  2. Pathologic complete response rate [ Time Frame: At time of surgery ]
  3. Major pathologic response rate [ Time Frame: Up to 24 weeks ]
  4. Cemiplimab concentration in serum over time [ Time Frame: From the first dose up to 90 days after the last dose ]
  5. Incidence of anti-drug antibody (ADA) titers for cemiplimab [ Time Frame: Up to 90 days after last dose ]
  6. Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations [ Time Frame: Up to 90 days after last dose ]
    The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.



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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

  • History of recurrent resectable CSCC that satisfies conditions as defined in the protocol
  • Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1

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 (irAEs)
  • Prior treatment with an agent that blocks the programmed cell death

    1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.

  • Prior treatment with other systemic immune modulating agent as defined in the protocol
  • M1 or N1, N2 (a, b, or c), or N3 CSCC. Patients with history of metastatic CSCC (distant or nodal), are excluded unless the disease-free interval is at least 3 years
  • Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
  • Patients with a history of solid organ transplant

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 ClinicalTrials.gov identifier (NCT number): NCT03889912


Contacts
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Contact: Clinical Trial Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, California
Regeneron Research Facility Withdrawn
Redwood City, California, United States, 94063
United States, Florida
Regeneron Research Facility Not yet recruiting
Delray Beach, Florida, United States, 33445
Regeneron Research Facility Recruiting
Tampa, Florida, United States, 33612
United States, Georgia
Regeneron Research Facility Recruiting
Atlanta, Georgia, United States, 30342
United States, Kentucky
Regeneron Research Facility Recruiting
Louisville, Kentucky, United States, 40202
United States, New York
Regeneron Research Facility Recruiting
New York, New York, United States, 10017
Regeneron Research Facility Recruiting
Victor, New York, United States, 14564
United States, North Carolina
Regeneron Research Facility Recruiting
Durham, North Carolina, United States, 27710
United States, Texas
Regeneron Research Facility Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03889912    
Other Study ID Numbers: R2810-ONC-1787
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
URL: https://vivli.org/

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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:
Recurrent
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