Cemiplimab/Peg-Interferon-α in Advanced CSCC

August 7, 2023 updated by: Baptist Health South Florida

Cemiplimab/PEG-Interferon-α Combination for Advanced Cutaneous Squamous Cell Carcinoma (aCSCC)

The primary purpose of this research study is to test the safety and possible harms of cemiplimab/peg-interferon-alpha, when it is given to participants at different dose levels. The researchers want to find out what effects (good and bad) cemiplimab/Peg-Interferon has on participants with advanced cutaneous squamous cell carcinoma (aCSCC) so that they can find the best dose to treat aCSCC and reduce side effects as much as possible.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

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 Locations

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study

  3. Participants must have histologically or cytologically confirmed aCSCC

    • Participants who present with unknown primary SCC at the time of diagnosis will be eligible if participants have a plausible primary skin site removed in the past
    • Similarly, participants with neck, parotid or facial lymph nodes biopsy proven SCC with no identifiable mucosal primary would also be eligible
  4. Participants must have measurable disease, defined by RECIST v1.1 as at least one lesion that can be accurately measured in at least one dimension of ≥ or equal than 10mm by CT, MRI, positron emission tomography/computed tomography (PET/CT) or ruler/caliper
  5. Male or female ≥ 18 years old
  6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2

  7. Participants must have normal organ function as defined below:

    • Absolute neutrophil count ≥ 1,500/mcl
    • Platelets ≥ 75,000
    • Aspartate transaminase (AST) or alanine aminotransferase (ALT) < 2.5 x upper limit of normal or up to 5x Upper Limit of Normal (ULN) if known to be secondary to liver metastasis
    • Serum creatinine < 1.5 or creatinine clearance ≥ 30 ml/min by either Cockcroft-Gault formula or 24-hour urine collection analysis
  8. For females of reproductive potential: pregnancy test must be negative (urine or serum), and use of highly effective contraception (like birth control pills and condoms) prior to screening and agreement to use such a method during study participation
  9. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner

Exclusion Criteria:

  1. Participants who have had chemotherapy, immunotherapy or targeted therapy within 21 days of protocol treatment initiation, or those who have not recovered to grade 1 CTCAE adverse events due to agents administered ≥ 3 weeks earlier
  2. Participants may not be receiving any other investigational agents
  3. Pregnancy or lactation
  4. Known allergic reactions to components of similar chemical or biologic composition to either cemiplimab or interferon
  5. Uncontrolled ongoing illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction < 30 days, cerebrovascular accident/transient ischemic attack (CVA/TIA) < 30 days, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

  6. Any organ transplant participants on immunosuppressive agents

    • Participants with chronic lymphocytic leukemia (CLL) or other hematologic malignancies are allowed as long as they meet all other criteria listed above

  7. Patient must not be candidates for curative locoregional treatments

    • Participants with recurrent locoregional disease for who a resection is unacceptably morbid and unlikely to be curative are eligible
  8. Participants with autoimmune disease on immunosuppressive therapy
  9. Participants with a history of non-infectious pneumonitis

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha)
Cemiplimab administered at 350 mg intravenous (IV) every three weeks for up to 2 years. PEG-IFN-alpha administered subcutaneously weekly at doses of 45 mcg to 135 mcg for up to 1 year. Exact dosing will depend on when the participant is enrolled in the study and the number of serious adverse effects that have been encountered by previous participants, if any.
Drug: Cemiplimab-Rwlc
350 mg via IV infusion over 30 minutes every 3 weeks for up to two years
Other Names:
  • Libtayo
Drug: PEG-IFN alfa-2a

Self-administered by the participant via subcutaneous injection in the abdomen or thigh weekly for up to one year. Participants will receive one of three doses:

Dose level 0: 45 mcg

Dose level 1: 90 mcg

Dose level 2: 135 mcg

Dose level 0 is considered the starting dose and sequential cohorts of three participants will be treated with escalated doses until the maximum tolerated dose is established.

Other Names:
  • PEGASYS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Incidence of Dose Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) Leading to Discontinuation or Death
Time Frame: 2 years

DLT rate by dose level, frequency distribution of treated participants with AE using the worst common terminology criteria grade. Participants will be counted only (1) once at the preferred term level, (2) once at the system organ class level, and (3) once in the "total participant" row at their worst common terminology criteria grade, regardless of system organ class or preferred term.

The DLT window of observation will be during treatment cycle 1 only (i.e., during the first 21-day cycle; adverse events (AEs) meeting the definition of a DLT but occurring after this period will not be considered DLTs). The occurrence of certain toxicities during treatment cycle 1 will be considered a DLT, if assessed by the investigator to be possibly related or related to PEG-IFN-α and/or cemiplimab.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response Rate (RR)
Time Frame: 2 years
RR is defined as the proportion of participants whose best overall response is complete (CR) or partial (PR).
2 years
Duration of Response (DOR)
Time Frame: 2 years
DOR is defined as the amount of time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first in participants who had achieved CR or PR.
2 years
Progression-free Survival (PFS)
Time Frame: 2 years
PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first
2 years
Overall Survival (OS)
Time Frame: 2 years
OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.
2 years

Collaborators and Investigators

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

Sponsor

Baptist Health South Florida

Collaborators

Regeneron Pharmaceuticals

Investigators

  • Principal Investigator: Guilherme Rabinowits, M.D., Miami Cancer Institute at Baptist Health, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

February 6, 2023

First Posted (Actual)

February 15, 2023

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-RAB-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

No

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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