Clinical trial NCT04154943: Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Official title: A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cutaneous Squamous Cell Carcinoma
Keywords: CSCC
Stage II
Stage III
Stage IV
CSCC of Head/neck
CSCC of Extremity
CSCC of Trunk
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2019-11-07
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Key Inclusion Criteria

* 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.
* At least 1 lesion that is measurable by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria

* Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia \[CLL\]) at any time
* Distant metastatic disease (M1), visceral and/or distant nodal
* Prior radiation therapy for CSCC
* Patients with a condition requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
* Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
* 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.
* Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
* Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Primary outcomes:
measure: Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
timeFrame: Up to 12 Weeks
measure: Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
timeFrame: Up to 12 weeks
measure: Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
timeFrame: Up to 12 Weeks
measure: Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
timeFrame: Up to 12 Weeks
measure: Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
timeFrame: Up to 12 Weeks
measure: Number of Participants With Planned and Actual Post-Surgical Management
timeFrame: Up to 14 Weeks
measure: Event Free Survival (EFS)
timeFrame: Up to 50 Months
measure: Disease Free Survival (DFS)
timeFrame: Up to 47 Months
measure: Overall Survival (OS)
timeFrame: Up to 50 Months
measure: Incidence of Adverse Events (AEs)
timeFrame: Up to 52 Months
measure: Incidence of Serious Adverse Events (SAEs)
timeFrame: Up to 52 Months
measure: Incidence of Deaths
timeFrame: Up to 52 Months
measure: Incidence of Laboratory Abnormalities
timeFrame: Up to 52 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Regeneron Study Site
state: California
city: Washington
country: United States
facility: Regeneron Study Site
state: District of Columbia
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Tampa
country: United States
facility: Regeneron Study Site
state: Florida
city: Baltimore
country: United States
facility: Regeneron Study Site
state: Maryland
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Boston
country: United States
facility: Regeneron Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Regeneron Study Site
state: Michigan
city: Omaha
country: United States
facility: Regeneron Study Site
state: Nebraska
city: New York
country: United States
facility: Regeneron Study Site
state: New York
city: Charlotte
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Durham
country: United States
facility: Regeneron Study Site
state: North Carolina
city: Cleveland
country: United States
facility: Regeneron Study Site
state: Ohio
city: Dallas
country: United States
facility: Regeneron Study Site
state: Texas
city: Houston
country: United States
facility: Regeneron Study Site
state: Texas
city: St Leonards
country: Australia
facility: Regeneron Study Site
state: New South Wales
city: Herston
country: Australia
facility: Regeneron Study Site
state: Queensland
city: Melbourne
country: Australia
facility: Regeneron Study Site
state: Victoria
city: Dresden
country: Germany
facility: Regeneron Study Site
city: Essen
country: Germany
facility: Regeneron Study Site
city: Kiel
country: Germany
facility: Regeneron Study Site
city: Tübingen
country: Germany
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: Gross ND, Miller DM, Khushalani NI, Divi V, Ruiz ES, Lipson EJ, Meier F, Su YB, Swiecicki PL, Atlas J, Geiger JL, Hauschild A, Choe JH, Hughes BGM, Schadendorf D, Patel VA, Homsi J, Taube JM, Lim AM, Ferrarotto R, Kaufman HL, Seebach F, Lowy I, Yoo SY, Mathias M, Fenech K, Han H, Fury MG, Rischin D. Neoadjuvant Cemiplimab for Stage II to IV Cutaneous Squamous-Cell Carcinoma. N Engl J Med. 2022 Oct 27;387(17):1557-1568. doi: 10.1056/NEJMoa2209813. Epub 2022 Sep 12.