Advanced cutaneous squamous cell carcinoma
Conditions
Interventions
Product Name: REGN2810
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Cemiplimab
CAS Number: 1801342-60-8
Current Sponsor code: REGN2810
Other descriptive name: anti-PD-1 mAb
Concen
Sponsors
Regeneron Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 216 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 217
Exclusion criteria
Exclusion criteria: A patient who meets any of the following criteria will be excluded from the study: 1.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). 2.Prior treatment with an agent that blocks the PD-1/PD-L1 pathway. 3.Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) prior to the first dose of cemiplimab, or (b) associated with immunemediated adverse events that were = grade 1 within 90 days prior to the first dose of cemiplimab, or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent. 4.Untreated brain metastasis(es) that may be considered active. Patients with previously treated brain metastases may participate provided that the lesion(s) is (are) stable (without evidence of progression for at least 6 weeks on imaging obtained in the screening period), and there is no evidence of new or enlarging brain metastases, and the patient does not require any immunosuppressive doses of systemic corticosteroids for management of brain metastasis(es) within 4 weeks of first dose of cemiplimab. 5.Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab. 6.Active infection requiring therapy, including infection with human immunodeficiency virus, or active infection with hepatitis B virus or hepatitis C virus. 7.History of pneumonitis within the last 5 years 8.History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments. 9.Patients with a history of solid organ transplant . 10.Prior treatment with a BRAF inhibitor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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) CSCC, or unresectable locally advanced CSCC. G1 consists of patients with metastatic (nodal or distant) CSCC treated with 3 mg/kg cemiplimab intravenously (IV) Q2W. G2 consists of patients with unresectable locally advanced CSCC, treated with cemiplimab 3 mg/kg IV Q2W. Group 3 consists of patients with metastatic (nodal or distant) CSCC treated with cemiplimab 350 mg IV Q3W. G4 consists of patients with advanced CSCC [metastatic (nodal or distal) or unresectable locally advanced] treated with cemiplimab 600 mg IV Q4W. Clinical benefit is measured by ORR according to central review in each group. 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) treated with cemiplimab 350 mg IV Q3W.;Secondary Objective: The secondary objectives for groups 1 to 4, and Group 6 are: -To estimate ORR according to investigator review; -To estimate the duration of response (DOR), progression free survival (PFS) and overall survival (OS), PFS, and OS by central and investigator review; -To estimate the complete response (CR) rate by central review; -To assess the safety and tolerability of cemiplimab; -To assess the PK of cemiplimab (at select sites only) -To assess the immunogenicity of cemiplimab For Groups 1 to 5 only: -To assess the impact of cemiplimab on quality of life using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Group 6 only: To assess relationships between PD-L1 status (by immunohistochemistry [IHC]) and efficacy measures (ORR, DOR, PFS).;Primary end point(s): The primary efficacy endpoint for this study is ORR according to central review during the 12 treatment cycles (Group 1, 2 and 6) or | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary efficacy outcome measures are: - ORR for Group 1 through 6 by investigator assessments - DOR - PFS - OS - CR rate - Change in scores of patient-reported outcomes on EORTC QLQ-C30 (except Group 6) - Anti-drug antibodies (ADA) - For Group 6 only: To assess relationships between PD-L1 status (by IHC) and efficacy measures (ORR, DOR, PFS).;Timepoint(s) of evaluation of this end point: Patients should receive response assessments according to the treatment schedule of their cohort. | — |
Countries
Australia, Brazil, France, Germany, Greece, Italy, New Zealand, Spain, United States
Contacts
Public ContactClinical Trial Management
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed