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PD-1 Inhibitor

Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha) for Squamous Cell Carcinoma

Phase 1

Waitlist Available

Led By Guilherme Rabinowits, M.D.

Research Sponsored by Baptist Health South Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial tests the safety & impacts of a drug to treat advanced skin cancer. Researchers aim to find the best dose to treat it with minimal side effects.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Total Incidence of Dose Limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs) Leading to Discontinuation or Death

Secondary outcome measures

Duration of Response (DOR)

Overall Survival (OS)

Progression-free Survival (PFS)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cemiplimab-Rwlc

2019

Completed Phase 2

~40

PEG-IFN alfa-2a

2012

Completed Phase 4

~950

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Baptist Health South FloridaLead Sponsor

48 Previous Clinical Trials

7,831 Total Patients Enrolled

Regeneron PharmaceuticalsIndustry Sponsor

616 Previous Clinical Trials

379,845 Total Patients Enrolled

Guilherme Rabinowits, M.D.Principal InvestigatorMiami Cancer Institute at Baptist Health, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha) therapies?

"The safety of Cemiplimab and Pegylated Interferon-alpha (PEG-IFN-alpha) were rated at a 1, as this is an initial testing phase where limited data exists supporting the drug's safety or efficacy."

Answered by AI

Is this research actively seeking participants?

"As per the details shared on clinicaltrials.gov, this trial is no longer recruiting patients. Initially posted in March of 2023 and last updated February 6th of that year, 2571 other studies are presently accepting enrolment from individuals seeking treatment options."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cemiplimab/Peg-Interferon-α in Advanced CSCC

2023. "Cemiplimab/Peg-Interferon-α in Advanced CSCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05729139.