Trial · NCT02760498

Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

NCT02760498, Phase 2, Completed, Regeneron Pharmaceuticals; results first posted 2024-12-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma. Trials, record NCT02760498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02760498

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
NCT number: NCT02760498
Status: Completed
Phases: Phase 2
Enrollment: 432 participants, actual
Lead sponsor: Regeneron Pharmaceuticals
Conditions: Advanced Cutaneous Squamous Cell Carcinoma
Interventions: cemiplimab
First posted: 2016-05-03
Last updated: 2025-05-28
Other registries' IDs: eudract:2016-000105-36
Results first posted: 2024-12-11

Source ClinicalTrials.gov

Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR) by Independent Central Review	Up to 108 weeks	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.
Secondary	ORR by Investigator Assessment	Up to 108 weeks	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.
Secondary	Duration of Response (DOR) by Independent Central Review	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	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.
Secondary	DOR by Investigator Assessment	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	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.
Secondary	Progression-Free Survival (PFS) by Independent Central Review	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	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.
Secondary	PFS by Investigator Assessment	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	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.
Secondary	Overall Survival (OS)	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	OS was measured from start of treatment until death due to any cause.
Secondary	Complete Response (CR) Rate by Independent Central Review	Up to 108 weeks	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.
Secondary	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	Baseline, Up to Cycle 12 Day 1 (Week 89)	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.
Secondary	Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	Up to 108 weeks plus 105 days (5 half-lives)	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.

1 to 10 of 16Source ClinicalTrials.gov

See all 16 registered outcomes

Outcomes16

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Response Rate (ORR) by Independent Central Review	Up to 108 weeks	The Full Analysis Set (FAS) included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this analysis.	percentage of participants	NUMBER
SECONDARY	ORR by Investigator Assessment	Up to 108 weeks	The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	percentage of participants	NUMBER
SECONDARY	Duration of Response (DOR) by Independent Central Review	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR who were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	months	MEDIAN
SECONDARY	DOR by Investigator Assessment	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants with confirmed CR or PR that are evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	months	MEDIAN
SECONDARY	Progression-Free Survival (PFS) by Independent Central Review	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	months	MEDIAN
SECONDARY	PFS by Investigator Assessment	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	months	MEDIAN
SECONDARY	Overall Survival (OS)	Up to approximately 65 months (treatment period + follow-up including survival follow-up)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants who received at least one dose of cemiplimab and were evaluable for this outcome measure. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	months	MEDIAN
SECONDARY	Complete Response (CR) Rate by Independent Central Review	Up to 108 weeks	The FAS included all enrolled participants. Only Groups 1, 2, 3, 4, and 6 were planned for this outcome measure.	percentage of participants	NUMBER
SECONDARY	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	Baseline, Up to Cycle 12 Day 1 (Week 89)	The FAS included all enrolled participants. Here, 'Overall number of participants analyzed' signifies participants evaluable for this outcome measure and Number Analyzed is the number evaluable at each time point. Only Groups 1, 2, 3, and 4 were planned for this outcome measure.	score on a scale	MEAN
SECONDARY	Number of Participants With Any Treatment Emergent Adverse Event (TEAE)	Up to 108 weeks plus 105 days (5 half-lives)	The Safety Analysis Set (SAF) included all enrolled participants who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 16Source ClinicalTrials.gov

See all 16 outcomes

Results by group126

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Response Rate (ORR) by Independent Central Review	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	50.8	95% Confidence Interval 37.5 to 64.1	percentage of participants
Overall Response Rate (ORR) by Independent Central Review	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	44.9	95% Confidence Interval 33.6 to 56.6	percentage of participants
Overall Response Rate (ORR) by Independent Central Review	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	46.4	95% Confidence Interval 33.0 to 60.3	percentage of participants
Overall Response Rate (ORR) by Independent Central Review	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	61.9	95% Confidence Interval 48.8 to 73.9	percentage of participants
Overall Response Rate (ORR) by Independent Central Review	Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W	47.3	95% Confidence Interval 39.5 to 55.2	percentage of participants
ORR by Investigator Assessment	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	50.8	95% Confidence Interval 37.5 to 64.1	percentage of participants
ORR by Investigator Assessment	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	56.4	95% Confidence Interval 44.7 to 67.6	percentage of participants
ORR by Investigator Assessment	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	55.4	95% Confidence Interval 41.5 to 68.7	percentage of participants
ORR by Investigator Assessment	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	63.5	95% Confidence Interval 50.4 to 75.3	percentage of participants
ORR by Investigator Assessment	Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W	52.7	95% Confidence Interval 44.8 to 60.5	percentage of participants

1 to 10 of 126Source ClinicalTrials.gov

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Participant flow30

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	59
Overall Study	STARTED	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	78
Overall Study	STARTED	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	56
Overall Study	STARTED	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	63
Overall Study	STARTED	Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W	9
Overall Study	STARTED	Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W	167
Overall Study	Received at Least 1 Dose of Study Drug	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	59
Overall Study	Received at Least 1 Dose of Study Drug	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	78
Overall Study	Received at Least 1 Dose of Study Drug	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	56
Overall Study	Received at Least 1 Dose of Study Drug	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	63

1 to 10 of 30Source ClinicalTrials.gov

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Adverse events2,672

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	17	59	29
other	Diarrhoea	Gastrointestinal disorders	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	23	78	42
other	Diarrhoea	Gastrointestinal disorders	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	13	56	18
other	Diarrhoea	Gastrointestinal disorders	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	17	63	23
other	Diarrhoea	Gastrointestinal disorders	Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W	3	9	3
other	Diarrhoea	Gastrointestinal disorders	Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W	39	165	58
other	Diarrhoea	Gastrointestinal disorders	Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W	0	12	0
other	Diarrhoea	Gastrointestinal disorders	Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W	1	7	2
other	Nausea	Gastrointestinal disorders	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	14	59	17
other	Nausea	Gastrointestinal disorders	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	20	78	25

1 to 10 of 2,672Source ClinicalTrials.gov

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Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	27	59
Total, all-cause mortality	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	19	78
Total, all-cause mortality	Group 3 (Participants With mCSCC): Cemiplimab 350 mg IV Q3W	26	56
Total, all-cause mortality	Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg IV Q4W	23	63
Total, all-cause mortality	Group 5 (Participants With mCSCC and laCSCC): Cemiplimab 438 mg SC + 350 mg IV Q3W	2	9
Total, all-cause mortality	Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W	59	165
Total, all-cause mortality	Group 6a (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 350 mg SC Q3W	2	12
Total, all-cause mortality	Group 6b (Participants With mCSCC and laCSCC): Cemiplimab 350 mg IV Q3W to 1050 mg SC Q6W	0	7
Total, other adverse events	Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg IV Q2W	56	59
Total, other adverse events	Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg IV Q2W	75	78

1 to 10 of 24Source ClinicalTrials.gov

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Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29863979	DERIVED	PubMed
31952975	DERIVED	PubMed
32554615	DERIVED	PubMed
33768419	DERIVED	PubMed
34413166	DERIVED	PubMed
38471711	DERIVED	PubMed
39245360	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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