Trials / Withdrawn
WithdrawnNCT05729139
Cemiplimab/Peg-Interferon-α in Advanced CSCC
Cemiplimab/PEG-Interferon-α Combination for Advanced Cutaneous Squamous Cell Carcinoma (aCSCC)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Baptist Health South Florida · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2026-07-01
- Completion
- 2028-07-01
- First posted
- 2023-02-15
- Last updated
- 2023-08-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05729139. Inclusion in this directory is not an endorsement.