Study of Cemiplimab in Patients with type of skin cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Not possible to specify, Diseases [C] - Neoplasms [C04]

Trial duration

19 Jan 2021 → 20 Nov 2025

Decision date (initial)

2022-09-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Regeneron Pharmaceuticals, Inc.

External identifiers

EU CT number

2022-500811-37-00

EudraCT number

2019-003007-35

ClinicalTrials.gov

NCT04154943

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

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

Secondary objectives 5

1. 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
2. To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)
3. To evaluate the safety profile of neoadjuvant cemiplimab
4. 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
5. To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to postsurgery pathology review, both according to investigator review and independent surgical expert review

Conditions and MedDRA coding

Stage II to IV cutaneous squamous cell carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
2. At least 1 lesion that is measurable by RECIST 1.1
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Adequate organ, bone marrow function, and hepatic function as defined in the protocol NOTE: Other protocol defined Inclusion Criteria apply

Exclusion criteria 8

1. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
2. Distant metastatic disease (M1), visceral and/or distant nodal
3. Prior radiation therapy for CSCC
4. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
5. Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date
6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
8. Active tuberculosis NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is pathologic complete response (pCR) rate assessed by independent central pathology review

Secondary endpoints 13

1. Major pathologic response (mPR) rate assessed by independent central pathology review
2. pCR rate assessed by local pathology review
3. mPR rate assessed by local pathology review
4. Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1
5. Event free survival (EFS)
6. Disease free survival (DFS)
7. Overall survival (OS)
8. Incidence of adverse events (AEs)
9. Incidence of serious adverse events (SAEs)
10. Incidence of deaths
11. Incidence of laboratory abnormalities
12. Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab
13. Change in post-surgical management plan in the screening period versus actual post-surgical management

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 6

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications