NCT05574101

A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

A Phase II, Multicenter, Single-Arm Clinical Trial of Radiotherapy and CeMiPlimAb: Rwlc ImmunoTherapy for Locally Advanced, Unresectable Cutaneous Squamous Cell Carcinoma: RAMPART

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

Conditions

• Cutaneous Squamous Cell Carcinoma
• Skin Cancer
• Squamous Cell Carcinoma
• Locally Advanced Squamous Cell Carcinoma
• Locally Advanced Squamous Cell Carcinoma of the Skin
• Locally Advanced Cutaneous Squamous Cell Carcinoma
• Locally Advanced Skin Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cemiplimab	Participants will undergo baseline imaging, followed by two doses of neoadjuvant cemiplimab at a dose of 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days). Then, participants will receive concurrent cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) concurrently with RT to 70 Gy in 35 fractions over 7 weeks. Thereafter, participants will receive 38 weeks of cemiplimab 350 mg intravenously over 30 minutes every 3 weeks (+/-3 days) for a cumulative total of 12 months of cemiplimab.
RADIATION	Radiotherapy	Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Timeline

• Start date: 2022-10-06
• Primary completion: 2026-10-06
• Completion: 2026-10-06
• First posted: 2022-10-10
• Last updated: 2025-08-08

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study