NCT02760498 · CITED IN SOURCE DOCUMENTS

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-05-28

The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Overall Response Rate (ORR) by Independent Central Review

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outcome · POSTED

ORR by Investigator Assessment

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outcome · POSTED

Duration of Response (DOR) by Independent Central Review

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outcome · POSTED

DOR by Investigator Assessment

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outcome · POSTED

Progression-Free Survival (PFS) by Independent Central Review

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outcome · POSTED

PFS by Investigator Assessment

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Complete Response (CR) Rate by Independent Central Review

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outcome · POSTED

Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score

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outcome · POSTED

Number of Participants With Any Treatment Emergent Adverse Event (TEAE)

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outcome · POSTED

Peak Concentration (Cmax) of Cemiplimab

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outcome · POSTED

Trough Concentration (Ctrough) of Cemiplimab

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outcome · POSTED

Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies

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outcome · POSTED

ORR by Independent Central Review for Participants With Evaluable PD-L1 Assays

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outcome · POSTED

DOR by Independent Central Review for Participants With Evaluable PD-L1 Assays

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outcome · POSTED

PFS by Independent Central Review for Participants With Evaluable PD-L1 Assays

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility 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
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received cemiplimab 3 milligrams (mg)/kilogram (kg) intravenously (IV) every 2 weeks (Q2W) during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
intervention Names
Drug: cemiplimab
label
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
type
EXPERIMENTAL
description
Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
intervention Names
Drug: cemiplimab
label
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
type
EXPERIMENTAL
description
Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
intervention Names
Drug: cemiplimab
label
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
type
EXPERIMENTAL
description
Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
intervention Names
Drug: cemiplimab
label
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
type
EXPERIMENTAL
description
Participants received a single subcutaneous (SC) dose of cemiplimab followed by cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
intervention Names
Drug: cemiplimab
label
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
type
EXPERIMENTAL
description
Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).
intervention Names
Drug: cemiplimab
label
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
type
EXPERIMENTAL

interventions

arm Group Labels
Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
name
cemiplimab
other Names
REGN2810
Libtayo
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 432
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR was defined as percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). For participants with metastatic disease, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeter (mm) \<1 (centimeter (cm). -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
measure
Overall Response Rate (ORR) by Independent Central Review
time Frame
Up to 108 weeks

secondary Outcomes

description
ORR was defined as percentage of participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. -PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions. -PR: Decrease of at least 50% in the sum the products of perpendicular longest dimensions of target lesion(s), maintained for at least 4 weeks and no new lesions.
measure
ORR by Investigator Assessment
time Frame
Up to 108 weeks
description
DOR was measured from the time measurement criteria were first met for CR/PR, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
measure
Duration of Response (DOR) by Independent Central Review
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
description
DOR was measured from the time measurement criteria were first met for CR/PR, as defined in Outcome Measure 1, whichever was recorded first, until the first date of recurrent or Progressive Disease (PD) or death due to any cause in participants with BOR of CR or PR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (World Health Organization (WHO) criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
measure
DOR by Investigator Assessment
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
description
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
measure
Progression-Free Survival (PFS) by Independent Central Review
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
description
PFS was measured from start of treatment until the first date of recurrent or PD, or death due to any cause. For participants with metastatic disease, RECIST v1.1 was used to determine PD. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -PD: At least a 20% increase in the sum of the diameters of target lesions with the sum demonstrating an absolute increase of at least 5 mm (0.5 cm), or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Clinical Response Criteria: -PD: increase of ≥ 25% (WHO criteria) in the sum of the products of perpendicular longest dimensions of target lesion(s) and/or the appearance of new lesions.
measure
PFS by Investigator Assessment
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
description
OS was measured from start of treatment until death due to any cause.
measure
Overall Survival (OS)
time Frame
Up to approximately 65 months (treatment period + follow-up including survival follow-up)
description
CR rate was defined as percentage of participants with BOR of CR. For participants with metastatic disease, RECIST v1.1 was used to determine BOR. For participants with unresectable locally advanced disease, clinical response criteria were used. RECIST v1.1 Criteria: -CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm \<1 cm. Clinical Response Criteria: -CR: All target and nontarget lesion(s) no longer visible, maintained for at least 4 weeks and no new lesions.
measure
Complete Response (CR) Rate by Independent Central Review
time Frame
Up to 108 weeks
description
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. Items contributing to the GHS/QoL, were scored 1 ("very poor") to 7 ("excellent"). A linear transformation was applied to the raw scores so that transformed score lies between 0 to 100. A higher score indicates better global health status/functioning and a negative change from baseline indicated less improvement.
measure
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (GHS) Score
time Frame
Baseline, Up to Cycle 12 Day 1 (Week 89)
description
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent adverse events (TEAEs) are defined as those not present at baseline or represent the exacerbation of a condition present at baseline during the on-treatment period or follow-up period. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.
measure
Number of Participants With Any Treatment Emergent Adverse Event (TEAE)
time Frame
Up to 108 weeks plus 105 days (5 half-lives)
measure
Peak Concentration (Cmax) of Cemiplimab
time Frame
Up to approximately 43 months
measure
Trough Concentration (Ctrough) of Cemiplimab
time Frame
Up to approximately 43 months
measure
Number of Participants With Treatment-Emergent Anti-cemiplimab Antibodies
time Frame
Up to approximately 43 months

Full study description

brief Summary: The goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) Cutaneous Squamous Cell Carcinoma (CSCC), or unresectable locally advanced CSCC.

Source references

references

citation
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