A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: - To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: - Major pathologic response (mPR) rate per independent central pathology review - pCR rate and mPR rate per local pathology review - ORR prior to surgery, according to local assessment using RECIST 1.1 - To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) - To evaluate the safety profile of neoadjuvant cemiplimab - To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review - To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
NCT04154943 — Cutaneous Squamous Cell Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/cutaneous-squamous-cell-carcinoma/NCT04154943/
Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service
This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.
NCT04123678 — Melanoma
Status: Completed
http://inclinicaltrials.com/melanoma/NCT04123678/
Test of Developed Interventions to Prevent Skin Cancer: a Randomized Study Targeting Danes Going on Vacation to Sunny Destinations With High UV Index
The aim of the study is to test a series of developed effective interventions targeting Danes going on vacation to sunny destinations to decrease sunburn by increasing use of shade, hats, protective clothing, and sunscreen to prevent skin cancer in the Danish population. It has been estimated that up to 90 % of all skin cancers could be avoided by behavioral changes. One of the main sources of UVR exposure in the Danish population is vacations to destinations with high UV index (UVI).
NCT03607578 — Malignant Melanoma
Status: Completed
http://inclinicaltrials.com/malignant-melanoma/NCT03607578/
A Biomarker Evaluation Trial of UAB30 in Renal Transplant Recipients at High Risk for Non-melanoma Skin Cancer
This is a randomized, double-blind, placebo-controlled biomarker study in renal transplant recipients with actinic damage and a history of basal cell carcinomas and/or cutaneous squamous cell carcinomas. There will be two arms to the study: 1) daily oral UAB30 for 28 days; and 2) daily oral placebo for 28 days. The total duration of the study is anticipated to be 5 years. The hypothesis being tested is that a significantly greater percentage of subjects randomized to oral UAB30 over a period of 28 days will achieve ≥30% reduction in biomarkers of proliferation and ≥30% increase in apoptosis biomarkers than those who receive placebo. Cyclin D1 will serve as the primary biomarker. This investigation will determine whether subjects randomized to UAB30 have an increase in all trans-retinoic acid responsive genes in the skin compared to those receiving placebo. This will include an examination of target effects of UAB30 by evaluating its effects in vivo in humans on the DNA damage response and Src signaling pathways.
NCT03327064 — Non-melanoma Skin Cancer
Status: Withdrawn
http://inclinicaltrials.com/non-melanoma-skin-cancer/NCT03327064/
Randomized Trial of a Photoaging Mirroring Intervention for Skin Cancer Prevention in Secondary Schools in Brazil - Study Protocol
Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.
NCT03178240 — Skin Cancer
Status: Not yet recruiting
http://inclinicaltrials.com/skin-cancer/NCT03178240/
Impact of Preoperative Acetaminophen and Carbohydrate Loading to on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Non-melanoma Skin Cancers
The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.
NCT03131713 — Non-melanoma Skin Cancer
Status: Completed
http://inclinicaltrials.com/non-melanoma-skin-cancer/NCT03131713/
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients
This is a pilot, phase 2, prospective, comparative study to evaluate the safety and efficacy of the combination of Levulan® Kerastick® for Topical Solution and blue light illumination using the BLU-U® Blue Light Photodynamic Therapy Illuminator (LevulanPDT). The study hypothesis is that post solid organ transplantation patients, highly susceptible to non-melanoma skin cancer, can be treated safely and effectively through clinical cyclic application of PDT, lessening morbidity and possible mortality for this immunosuppressed patient population.
NCT03110159 — Skin Cancer
Status: Completed
http://inclinicaltrials.com/skin-cancer/NCT03110159/
A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer
Photodynamic therapy (PDT) is a well established treatment option for superficial non melanoma skin cancer, such as superficial basal cell carcinoma (sBCC) and Bowen Disease (BD). However, a limited uptake of the topically applied photosensitizer methyl aminolevulinate (MAL) may reduce its efficacy. Pretreatment with an ablative carbon dioxide (CO2) laser has recently been studied in order to enhance the skin penetration of this photosensitizer. This study compares the results of a full ablative and a fractional ablative CO2 laser mode as pretreatment of PDT in the management of sBCC and BD. The endpoints efficacy, pain, aesthetics and patient preference are investigated during twelve months of follow up.
NCT03012009 — Superficial Basal Cell Carcinoma
Status: Completed
http://inclinicaltrials.com/superficial-basal-cell-carcinoma/NCT03012009/
A Phase II Study of Talimogene Laherparepvec Followed by Talimogene Laherparepvec + Nivolumab in Refractory T Cell and NK Cell Lymphomas, Cutaneous Squamous Cell Carcinoma, Merkel Cell Carcinoma, and Other Rare Skin Tumors
This phase II trial studies how well talimogene laherparepvec and nivolumab work in treating patients with lymphomas that do not responded to treatment (refractory) or non-melanoma skin cancers that have spread to other places in the body (advanced) or do not responded to treatment. Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving talimogene laherparepvec and nivolumab may work better compared to usual treatments in treating patients with lymphomas or non-melanoma skin cancers.
NCT02978625 — Merkel Cell Carcinoma
Status: Active, not recruiting
http://inclinicaltrials.com/merkel-cell-carcinoma/NCT02978625/
Tele-dermatology of Skin Cancer: a Randomized Trial Comparing Remote Assessment With Conventional Visits in a Cohort of Local Health Authority Employees in the Province of Bergamo (the Shoot the Mole Study)
The purpose of this study is to demonstrate the validity and utility of a tele-dermatology system in the midterm periodic screening of non-widespread skin lesions of recent onset or for which a specialized early classification is deemed to change the prognosis - including precancerous skin lesions as well as melanoma and non-melanoma skin cancers - compared to control visits at fixed follow-up.
NCT02902822 — Melanoma
Status: Completed
http://inclinicaltrials.com/melanoma/NCT02902822/