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Intralesional Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

Primary Purpose

Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cemiplimab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutaneous Squamous Cell Carcinoma focused on measuring CSCC, BCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

  • Dose Escalation: History of recurrent resectable CSCC that satisfies conditions as defined in the protocol
  • Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1

Key Exclusion Criteria

  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs)

  • Prior treatment with an agent that blocks the programmed cell death

    1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway.

  • Prior treatment with other systemic immune modulating agent as defined in the protocol
  • M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years
  • Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded.
  • Patients with a history of solid organ transplant
  • Has received a COVID-19 vaccination (initial series and booster) within 1 week of planned start of study medication

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Sites / Locations

  • Medical Dermatology SpecialistsRecruiting
  • Regeneron Research Facility
  • Therapeutics Clinical ResearchRecruiting
  • Dermatology Associates of the Palm BeachesRecruiting
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Regeneron Research Facility
  • Northeast Dermatology AssociatesRecruiting
  • NYU LangoneRecruiting
  • Rochester Dermatologic SurgeryRecruiting
  • Duke Cancer CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • INOVA Schar Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cemiplimab

Arm Description

Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated.

Outcomes

Primary Outcome Measures

Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Dose levels 1-3
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Dose levels 1-3 and cohorts A - C
The incidence and severity of injection site reactions (ISRs)
Dose levels 1-3 and cohorts A - C

Secondary Outcome Measures

Objective response rate (ORR)
Determined by the investigator using the modified World Health Organization (WHO) criteria
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery)
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery)
Cemiplimab concentration in serum over time
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.

Full Information

First Posted
March 6, 2019
Last Updated
September 19, 2023
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT03889912
Brief Title
Intralesional Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma
Official Title
A Phase 1 Study of Pre-Operative Cemiplimab (REGN2810), Administered Intralesionally, for Patients With Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2019 (Actual)
Primary Completion Date
October 26, 2023 (Anticipated)
Study Completion Date
January 11, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective is to characterize the safety and tolerability of cemiplimab injected intralesionally in patients with Cutaneous Squamous Cell Carcinoma (CSCC) or Basal Cell Carcinoma (BCC) The secondary objectives of this study are: To describe the objective response rate (ORR) in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC, according to modified World Health Organization (WHO) criteria To describe the pathologic complete response (CR) rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC To describe the major pathologic response rate in CSCC or BCC index lesions following intralesional injections of cemiplimab in patients with CSCC or BCC To evaluate systemic exposure of cemiplimab following intralesional injections of cemiplimab in patients with CSCC or BCC To assess the immunogenicity of cemiplimab in patients with CSCC or BCC To establish a recommended dose of intralesional cemiplimab for further study in patients with CSCC or BCC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
Keywords
CSCC, BCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Cohorts A and B will enroll sequentially (not randomized). Cohort C for BCC will enroll in parallel with, and independently of, Cohorts A and B for CSCC patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cemiplimab
Arm Type
Experimental
Arm Description
Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated.
Intervention Type
Drug
Intervention Name(s)
Cemiplimab
Other Intervention Name(s)
REGN2810, Libtayo
Intervention Description
Each patient will receive intralesional injections of cemiplimab every week (QW) or every other week (QOW) into the lesion at the assigned dose level for 5-12 weeks prior to scheduled surgery
Primary Outcome Measure Information:
Title
Incidence, nature, and severity of dose limiting toxicities (DLTs) (if any) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Description
Dose levels 1-3
Time Frame
From the first dose through day 28
Title
Incidence, nature, and severity of treatment-emergent adverse events (TEAEs) graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) v5
Description
Dose levels 1-3
Time Frame
From the first dose through day 28
Title
Incidence and severity of TEAEs graded according to the NCI CTCAE v5
Description
Dose levels 1-3 and cohorts A - C
Time Frame
From the first dose up to 90 days after the last dose
Title
The incidence and severity of injection site reactions (ISRs)
Description
Dose levels 1-3 and cohorts A - C
Time Frame
From the first dose to 90 days after the last dose
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
Determined by the investigator using the modified World Health Organization (WHO) criteria
Time Frame
At week 7; prior to week 13 surgery
Title
Pathologic complete response rate (or end of treatment biopsies, for patients who decline surgery)
Time Frame
At time of surgery
Title
Major pathologic response rate (or end of treatment biopsies, for patients who decline surgery)
Time Frame
At time of surgery
Title
Cemiplimab concentration in serum over time
Time Frame
From the first dose up to 90 days after the last dose
Title
Incidence of anti-drug antibody (ADA) titers for cemiplimab
Time Frame
Up to 90 days after last dose
Title
Selection of the recommended dose of cemiplimab for further study based on clinical and pharmacokinetic (PK) observations
Description
The determination of the phase 2 recommended dose will be based primarily on clinical safety observations, according to the dose escalation scheme.
Time Frame
Up to 90 days after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria Dose Escalation: History of recurrent resectable CSCC that satisfies conditions as defined in the protocol Patient must have measurable disease in the index lesion, as defined by modified WHO criteria. Measurable disease is defined as at least one lesion that is at least 1 cm in both of the longest perpendicular diameters. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Key Exclusion Criteria Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs) Prior treatment with an agent that blocks the programmed cell death 1 (PD-1)/ programmed cell death 1 ligand (PD-L1) pathway. Prior treatment with other systemic immune modulating agent as defined in the protocol M1 or N1, N2 (a, b, or c), or N3 CSCC or BCC. Patients with history of metastatic CSCC (distant or nodal), or metastatic BCC (distant or nodal) are excluded unless the disease-free interval is at least 3 years Concurrent malignancies, other than those with negligible risk of metastasis or death. Patients with hematologic malignancies, including chronic lymphocytic leukemia (CLL), are excluded. Patients with a history of solid organ transplant Has received a COVID-19 vaccination (initial series and booster) within 1 week of planned start of study medication Note: Other protocol defined Inclusion/Exclusion criteria apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Medical Dermatology Specialists
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Name
Regeneron Research Facility
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Individual Site Status
Withdrawn
Facility Name
Therapeutics Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Dermatology Associates of the Palm Beaches
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Individual Site Status
Recruiting
Facility Name
Regeneron Research Facility
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Completed
Facility Name
Regeneron Research Facility
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Completed
Facility Name
Regeneron Research Facility
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Completed
Facility Name
Northeast Dermatology Associates
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Dermatologic Surgery
City
Victor
State/Province
New York
ZIP/Postal Code
14564
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
INOVA Schar Cancer Institute
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
IPD Sharing URL
https://vivli.org/

Learn more about this trial

Intralesional Cemiplimab for Patients With Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma

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