Study of REGN2810 in Patients With Advanced Cutaneous Squamous Cell Carcinoma

Conditions

• Advanced Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• cemiplimab — DRUG

Study Details

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.

Key Dates

Start date

Apr 7, 2016

Status verified

May 2025

Primary completion

Oct 18, 2023

Completion

Oct 18, 2023

Study Design

Enrollment

432 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (Participants With mCSCC): Cemiplimab 3 mg/kg Q2W
  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).
• Experimental: Group 2 (Participants With laCSCC): Cemiplimab 3 mg/kg Q2W
  Participants received cemiplimab 3 mg/kg IV Q2W during each 8-week treatment cycle, for up to 96 weeks (12 cycles).
• Experimental: Group 3 (Participants With mCSCC): Cemiplimab 350 mg Q3W
  Participants received cemiplimab 350 mg IV every 3 weeks (Q3W) during each 9-week treatment cycle, for up to 54 weeks (6 cycles).
• Experimental: Group 4 (Participants With mCSCC and laCSCC): Cemiplimab 600 mg Q4W
  Participants received cemiplimab 600 mg IV every 4 weeks (Q4W) during each 8-week treatment cycle, for up to 48 weeks (6 cycles).
• Experimental: Group 5 (Participants With mCSCC and laCSCC): Cemiplimab SC + 350 mg Q3W
  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).
• Experimental: Group 6 (Participants With mCSCC and laCSCC): Cemiplimab 350 mg Q3W
  Participants received cemiplimab 350 mg IV Q3W during each 9-week treatment cycle, for up to 108 weeks (12 cycles).

Primary Outcome Measure

Overall Response Rate (ORR) by Independent Central Review [ Time Frame: Up to 108 weeks ]

Locations (26)

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