MedTrace Logo

Cemiplimab/Peg-Interferon-α in Advanced CSCC

NCT05729139 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-08-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Cemiplimab-Rwlc

350 mg via IV infusion over 30 minutes every 3 weeks for up to two years

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.

Sponsors & Collaborators

Principal Investigators

  • Guilherme Rabinowits, M.D. · Miami Cancer Institute at Baptist Health, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2026-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05729139 on ClinicalTrials.gov