Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma, Squamous Cell

Skin Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Skin Diseases

All Drugs and Chemicals

Antineoplastic Agents

Immunomodulating Agents

Cemiplimab

Antineoplastic Agents, Immunological

Participants have locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC

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.

Participants will receive radiotherapy to 70 Gy in 35 fractions over 7 weeks concurrently with cemiplimab

Radiotherapy

Christopher Barker, MD

Lara Dunn, MD

Ryan Lanning, MD, PhD

Evan Wuthrick, MD

Zachary Buchwald, MD, PhD

Shlomo Koyman, MD

Thomas Galloway, MD

Bhisham Chere, MD

Upendra Parvathaneni, MD

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.

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

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

The primary endpoint for this study is disease free survival at 18 months (week 78 +/- 3 weeks) after starting cemiplimab.

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer	NCT05574101	Cutaneous Squam... Skin Cancer Squamous Cell C... Locally Advance... Locally Advance... Locally Advance... Locally Advance...	Cemiplimab Radiotherapy	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer	NCT05574101	Cutaneous Squam... Skin Cancer Squamous Cell C... Locally Advance... Locally Advance... Locally Advance... Locally Advance...	Cemiplimab Radiotherapy	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for rampart

Every month we try and update this database with for rampart cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for rampart

Every month we try and update this database with for rampart cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for rampart cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.