Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

July 25, 2024 updated by: Regeneron Pharmaceuticals

A Phase 2 Peri-Operative Study of Treatment With Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Patients With Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)

This study is researching an investigational drug called REGN2810, also known as cemiplimab, and when combined with another investigational drug called REGN3767, also known as fianlimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on a type of skin cancer known as cutaneous squamous cell carcinoma (CSCC).

The aim of the study is to see if cemiplimab or cemiplimab in combination with fianlimab can eliminate or reduce the number of living cancer cells in tumor(s) if taken before surgery.

The study is looking at several other research questions, including:

  • Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make it possible to have a less extensive surgery or a different treatment plan after surgery
  • Whether taking cemiplimab or cemiplimab in combination with fianlimab before surgery may make the cancer less likely to come back after surgery
  • What side effects may happen from taking the cemiplimab or cemiplimab in combination with fianlimab
  • How much of the cemiplimab or cemiplimab in combination with fianlimab is in the blood at different times
  • Whether the body makes antibodies against the study drug(s) (which could make the drug(s) less effective or could lead to side effects)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Stage III/IV (M0) CSCC, for which surgery would be recommended in routine clinical practice
  2. Tumor biopsy is required during screening period as described in the protocol
  3. Participant is willing to undergo delayed surgery
  4. At least 1 lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  6. Adequate organ and bone marrow function as described in the protocol

Key Exclusion Criteria:

  1. Stage I or II CSCC
  2. Anogenital, penile, vermilion lip CSCC
  3. CSCC bone invasion
  4. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy as described in the protocol
  5. Prior radiation therapy for CSCC
  6. Myocardial infarction within 6 months of enrollment, or history of myocarditis.
  7. Prior treatment with anti-cancer systemic therapy within the last 3 years prior to projected enrollment date as described in the protocol

Note: Other protocol-defined Inclusion/Exclusion Criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cemiplimab
Drug: cemiplimab
Administered Intravenous (IV) infusion every three weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo
Experimental: fianlimab+cemiplimab
Drug: cemiplimab
Administered Intravenous (IV) infusion every three weeks (Q3W)
Other Names:
  • REGN2810
  • Libtayo
Drug: fianlimab
IV infusion Q3W
Other Names:
  • REGN3767

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pathological complete response (pCR) rate by blinded independent pathological review (BIPR)
Time Frame: Up to 100 days
Up to 100 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Up to 3 years
Up to 3 years
pCR rate by local pathological review
Time Frame: Up to 100 days
Up to 100 days
Major pathological response (MPR)
Time Frame: Up to 100 days
Up to 100 days
Event-free survival (EFS)
Time Frame: Up to 3 years
Up to 3 years
Disease free survival (DFS)
Time Frame: Up to 3 years
Up to 3 years
Objective response rate (ORR) prior to surgery
Time Frame: Up to 100 days
Up to 100 days
Occurrence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 3 years
Up to 3 years
Occurrence of immune-mediated adverse events (imAEs)
Time Frame: Up to 3 years
Up to 3 years
Occurrence of treatment-related TEAEs
Time Frame: Up to 3 years
Up to 3 years
Occurrence of adverse event of special interest (AESI)
Time Frame: Up to 3 years
Up to 3 years
Occurrence of treatment-emergent serious adverse events (SAEs)
Time Frame: Up to 3 years
Up to 3 years
Occurrence of laboratory abnormalities
Time Frame: Up to 3 years
Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Up to 3 years
Occurrence of death due to TEAE
Time Frame: Up to 3 years
Up to 3 years
Occurrence of interruption of study drug(s) due to TEAEs
Time Frame: Up to 3 years
Up to 3 years
Occurrence of discontinuation of study drug(s) due to TEAEs
Time Frame: Up to 3 years
Up to 3 years
Occurrence of cancellation of surgery due to TEAE
Time Frame: Up to 100 days
Up to 100 days
Occurrence of delay to surgery due to TEAE
Time Frame: Up to 100 days
Up to 100 days
Concentrations of cemiplimab in serum
Time Frame: Up to 3 years
Up to 3 years
Concentrations of fianlimab in serum
Time Frame: Up to 3 years
Up to 3 years
Concentrations of other experimental agents (as applicable) in serum
Time Frame: Up to 3 years
Up to 3 years
Incidence of anti-drug antibodies (ADA) to cemiplimab
Time Frame: Up to 3 years
Up to 3 years
Incidence of ADA to fianlimab
Time Frame: Up to 3 years
Up to 3 years
Incidence of ADA to other experimental agents (as applicable)
Time Frame: Up to 3 years
Up to 3 years
Titer of ADA to cemiplimab
Time Frame: Up to 3 years
Up to 3 years
Titer of ADA to fianlimab
Time Frame: Up to 3 years
Up to 3 years
Titer of ADA to other experimental agents (as applicable)
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Regeneron Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 8, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R3767-ONC-2330
  • 2023-510514-38-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

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 made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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