Cemiplimab/Peg-Interferon-α in Advanced CSCC

Part of paid clinical trials in Miami, Florida.

Sponsor
Baptist Health South Florida
Study ID
NCT05729139
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab-Rwlc — DRUG
    350 mg via IV infusion over 30 minutes every 3 weeks for up to two years
  • PEG-IFN alfa-2a — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
Aug 2023
Primary completion
Jul 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Institute at Baptist Health, Inc.MiamiFlorida33176-

Find similar trials in Miami, FL

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
Miami Cancer Institute at Baptist Health, Inc.· Miami, FL

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