Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC for Squamous cell carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous cell carcinoma+9 More
Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Locally Advanced Squamous Cell Carcinoma
  • Squamous cell carcinoma
  • Cutaneous Squamous Cell Carcinoma
  • Cancer of the Skin
  • Locally Advanced Squamous Cell Carcinoma of the Skin
  • Locally Advanced Cutaneous Squamous Cell Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 18 months

18 months
Disease Free Survival

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Participants with locally advanced, unresectable cutaneous squamous cell carcino...
1 of 1

Experimental Treatment

34 Total Participants · 1 Treatment Group

Primary Treatment: Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCC · No Placebo Group · Phase 2

Participants with locally advanced, unresectable cutaneous squamous cell carcinoma/CSCCExperimental Group · 2 Interventions: Radiotherapy, Cemiplimab · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiotherapy
2017
Completed Phase 3
~2600
Cemiplimab
2015
Completed Phase 1
~400

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 18 months

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,285 Total Patients Enrolled
Christopher Barker, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
312 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a cutaneous squamous cell carcinoma which is locally advanced.
You have a mixed tumor that is predominantly squamous cell carcinoma.
Tumor is locally advanced
You have a non-eyelid tumor >4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.
You have a tumor of the eyelid or orbit or facial structures that is 2 centimeters or larger.
You have a minimum age of 18 years old.
Tumor or nodal disease with significant local invasion that precludes complete resection.
You have a tumor or nodal disease in an anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc).
You have a medical contraindication to surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 8th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.