Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

Phase 2

Active, not recruiting

• Conditions: Cutaneous Squamous Cell Carcinoma
• Interventions: Drug: Cemiplimab

• Registration Number: NCT04154943
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.

The secondary objectives of the study are:

* To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:

* Major pathologic response (mPR) rate per independent central pathology review

* pCR rate and mPR rate per local pathology review

* ORR prior to surgery, according to local assessment using RECIST 1.1

* To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)

* To evaluate the safety profile of neoadjuvant cemiplimab

* To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review

* To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2020-03-10
• Primary Completion: 2021-12-01
• Results First Submitted: 2022-11-30
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-08
• Study Completion: 2025-09-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 79

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cemiplimab	Cemiplimab	Will receive IV infusion Q3W

Primary Outcome Measures

Name	Time	Method
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review	Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review	Up to 12 Weeks
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review	Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review	Up to 12 Weeks
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1	Up to 12 Weeks
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab	Up to 12 Weeks
Number of Participants With Planned and Actual Post-Surgical Management	Up to 14 Weeks
Event Free Survival (EFS)	Up to 50 Months
Disease Free Survival (DFS)	Up to 47 Months
Overall Survival (OS)	Up to 50 Months
Incidence of Adverse Events (AEs)	Up to 52 Months
Incidence of Serious Adverse Events (SAEs)	Up to 52 Months
Incidence of Laboratory Abnormalities	Up to 52 Months
Incidence of Deaths	Up to 52 Months

Trial Locations

Locations (1)

Regeneron Study Site; 🇩🇪 Tübingen, Germany