Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard-of-Care Treatment for Resectable Stage III/IV Cutaneous Squamous Cell Carcinoma

Date Added
April 22nd, 2025
PRO Number
Pro00144157
Researcher
William Albergotti

List of Studies

Keywords
Cancer/Skin, Drug Studies, Men's Health, Stage III, Stage IV, Women's Health
Summary

This phase III study evaluates whether cemiplimab can shrink or prevent the return of cancer when combined with the usual approach for skin cancer more effectively than the usual approach alone. This study will enroll adults diagnosed with stage III/IV cutaneous squamous cell carcinoma. If eligible to participate in this study participants will be randomly assigned to 1 of 2 groups. Group 1 will receive the usual surgery used to treat this type of cancer. After surgery, they may get the usual type of radiation, depending on the results from the tumor tissue removed during surgery. Group 2 will receive cemiplimab before surgery every 3 weeks for up to 12 weeks. They may also receive radiation after surgery depending on the tumor tissue results from surgery. If treated with cemiplimab before surgery, then tumor tissue results will also determine whether or not they receive cemiplimab every 6 weeks for up to 24 weeks, after surgery, and radiation if given. Participants will be asked to complete quality of life questionnaires to understand how they are feeling during treatment and the effects of the treatment. Participants will be checked for sides effects 3 to 4 months for 2 years after treatment. After that, every 6 months for 1 year and then annually. The main risks are tiredness, diarrhea or constipation, nausea, rash or itching, change in thyroid function, and risk of progression of the cancer to require earlier surgery or to become inoperable. Alternatives to this treatment is standard of care surgery and radiation. The study benefit is cemiplimab may help in shrinking or stabilizing this type of skin cancer.

Institution
MUSC
Recruitment Contact
HCC clinical trails office
843-792-9321
hcc-clinicaltrials@musc.edu

Morbidity of locally recurrent cutaneous squamous cell carcinoma – a comparative case-control study

Date Added
November 25th, 2024
PRO Number
Pro00140037
Researcher
Joel Cook

List of Studies


Keywords
Cancer/Skin
Summary

To determine if locally recurrent cutaneous squamous cell carcinoma (cSCC) leads to increased patient morbidity, and, if so, to what extent. The main outcome will be the margin required to clear locally recurrent cSCC versus that of similar primary cSCC. Secondary outcomes will analyze number of mohs micrographic surgery (MMS) layers, the difference in area between the clinical lesion and the defect size, closure types and sizes, loss of function, and referrals (radiation, oncology, reconstruction, etc.) required for treatment.

Institution
MUSC
Recruitment Contact
Siddharth Srikakolapu
8438765074
srikakol@musc.edu

Utility and Histologic Effects of the J-Tip Device in Dermatologic Conditions Requiring Local Anesthesia

Date Added
May 2nd, 2023
PRO Number
Pro00107787
Researcher
Lara Wine Lee

List of Studies


Keywords
Cancer/Skin, Skin
Summary

This project is a pilot study to determine if use of the J-Tip Needle-Free Injection System, used to administer local anesthesia, has any effects on the appearance of skin samples when viewed under a microscope compared with skin samples that have been injected with local anesthesia using a needle. If use of the J-Tip device for local anesthesia delivery is shown not to alter the microscopic appearance of skin, anesthesia for skin biopsies in the future may potentially be performed without a needle, allowing for less fear and pain.

Institution
MUSC
Recruitment Contact
Lara Wine Lee
(843) 792-3021
winelee@musc.edu

Melanoma Margins Trial (MelMarT-II): A Phase III, multi-centre, multi-national randomised control trial investigating 1cm v 2cm wide excision margins for primary cutaneous melanoma

Date Added
September 1st, 2022
PRO Number
Pro00123127
Researcher
Andrea Abbott

List of Studies


Keywords
Cancer/Skin
Summary

This study is for patients with melanoma. This study is being done to answer if a 1-centimeter margin as good as a 2-centimeter margin at reducing the risk of melanoma returning.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

STAMP: Surgically Treated Adjuvant Merkel cell carcinoma with Pembrolizumab

Date Added
February 26th, 2019
PRO Number
Pro00086647
Researcher
Thai Ho

List of Studies

Keywords
Cancer, Cancer/Skin
Summary

This study is for patients that have been diagnosed with Merkle Cell Carcinoma. The investigational drug in this study is pembrolizumab. The purpose of this study is to compare the usual approach of post-surgery observation with or without radiation to using pembrolizumab with or without radiation after surgery. Participants can expect to be on this study for a total of 5 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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