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Skin Neoplasms clinical trials

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NCT ID: NCT06320353 Active, not recruiting - Skin Melanoma Clinical Trials

Study сomparing the Efficacy and Safety of RPH-075 and Keytruda® in Patients With Unresectable or Metastatic Skin Melanoma

Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The goal of this double-blind, randomized study is to establish the equivalence of the efficacy, safety and immunogenicity of the drugs RPH-075 (international nonproprietary name (INN) is pembrolizumab) and Keytruda® (INN is pembrolizumab) when used in patients with unresectable or metastatic skin melanoma first or second line therapy in a monotherapy regimen. The main task is to evaluate and compare the effectiveness of RPH-075 and Keytruda® drugs when used in patients with unresectable or metastatic skin melanoma as a 1 or 2 line therapy in monotherapy regimen, according to the objective response rate (ORR) parameter for up to 24 weeks of therapy.

NCT ID: NCT06227416 Active, not recruiting - Clinical trials for Squamous Cell Carcinoma

Skin Tumor Biomarkers by Mass Spectrometry Imaging

Start date: June 15, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate the ability of mass spectrometry imaging to locate aggregates of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) ex-vivo, and to distinguish areas containing these carcinomas from normal skin. It is suggested that non-melanoma skin cancer (NMSC) cells show a different profile of endogenous lipids than healthe skin tissue which can be used as identifying biomarkers. If that hypothesis is correct it will be possible in the future to develop real-time tissue diagnosis and treatment of NMSC using mass spectrometry guided surgery. Method between 60 and 100 patients with BCCs, SCCs, and actinic keratoses (AK) will be recruited. For patients referred for Mohs surgical procedure at the Department of Dermatology, Bispebjerg Hospital, to treat BCCs or SCCs, three skin sections (5-10 um thick) of the tissue that is already removed will be use in our study. One section will be HE stained so we know exactly where the regions of interest are. Two sections will be used for MS analysis (MSI spectrum and REIMS spectrum). When patients are referred for a procedure to have treated several actinic keratoses (grade 1, 2 or 3) at Department of Dermatology, Bispebjerg Hospital we will take an extra punch biopsy (2-4 mm) depending on the size of the lesion. The biopsy is embedded and sectioned. We will use 3 skin sections (5-10 um thick) we will again use one section for HE staining and two for MS analysis. Multivariate statistical analysis will be performed on all mass spectra using Matlab or similar program. Linear discriminant analysis will be used to identify spectral differences between pre-malignant, cancer and normal tissue. Classification performance will be recorded with a leave-one- patient- out cross- validation scheme.

NCT ID: NCT05774600 Active, not recruiting - Skin Cancer Clinical Trials

Virtual Sun Safe Workplaces Ph II (SSW Works)

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Americans who work outdoors are exposed to an extreme amount of solar ultraviolet radiation over a lifetime that substantially increases their risk for developing skin cancer. In Phase I, the feasibility of a virtual learning environment (VLE) for distributing the effective Sun Safe Workplaces (SSW) intervention to American employers will be established with input from senior managers and Hispanic and African American outdoor workers and development and evaluation of a prototype of the SSW Works VLE. In Phase II, the full SSW Works will be produced and tested for effectiveness at improving outdoor workers' sun protection in a randomized trial enrolling employers nationwide.

NCT ID: NCT05539157 Active, not recruiting - Clinical trials for Malignant Solid Tumor

Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

Start date: October 18, 2022
Phase: Phase 1
Study type: Interventional

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

NCT ID: NCT05451680 Active, not recruiting - Skin Tumor Clinical Trials

Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

NCT ID: NCT05200143 Active, not recruiting - Clinical trials for Refractory Cutaneous Melanoma

Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma

Start date: June 8, 2022
Phase: Phase 2
Study type: Interventional

The primary objective of this clinical trial is to evaluate the clinical efficacy and progression free survival of the triplet combination of ipilimumab + nivolumab + cabozantinib in patients with anti-PD-1/PD-L1 refractory metastatic cutaneous melanoma.

NCT ID: NCT05176470 Active, not recruiting - Stage IV Melanoma Clinical Trials

Neoadj Admin Autologous Tumor Infiltrating Lymphocytes & Pembrolizumab for Treatment of Adv Melanoma Patients

Start date: July 1, 2022
Phase: Phase 1
Study type: Interventional

This phase I/II trial tests the safety and side effects of LN-144 (Lifileucel) and pembrolizumab in treating patients with stage IIIB-D or stage IV melanoma that has spread to nearby tissue or lymph nodes. Biological therapies, such as LN-144 (Lifileucel), use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lifileucel and pembrolizumab may make the tumor smaller.

NCT ID: NCT04967196 Active, not recruiting - Metastatic Melanoma Clinical Trials

Ipilimumab and Nivolumab for the Treatment of Stage III-IV Unresectable Metastatic Melanoma

Start date: September 16, 2021
Phase: Phase 1
Study type: Interventional

This phase I trial identifies the best dose of ipilimumab that can be administered through the DoseConnect™ device followed by nivolumab in treating patients with stage III melanoma that cannot be removed by surgery (unresectable) or stage IV melanoma that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

NCT ID: NCT04940299 Active, not recruiting - Metastatic Melanoma Clinical Trials

Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma

Start date: September 23, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial investigates the side effects of tocilizumab, ipilimumab, and nivolumab in treating patients with melanoma, non-small cell lung cancer, or urothelial carcinoma that has spread to nearby tissue or lymph nodes (locally advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tocilizumab is a monoclonal antibody that may interfere with the immune system to decrease immune-related toxicities. Giving tocilizumab, ipilimumab, and nivolumab may kill more tumor cells.

NCT ID: NCT04913220 Active, not recruiting - Malignant Melanoma Clinical Trials

A Study of SAR444245 Combined With Cemiplimab for the Treatment of Participants With Various Advanced Skin Cancers (Pegathor Skin 201)

Start date: July 15, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: -To determine the antitumor activity of SAR444245 in combination with cemiplimab. Secondary Objectives: - To determine the recommended phase 2 dose and to assess the safety profile of SAR444245 when combined with cemiplimab - To assess other indicators of antitumor activity - To assess the concentrations of SAR444245 when given in combination with cemiplimab - To assess the immunogenicity of SAR444245 - To assess active concentrations of cemiplimab when given in combination with SAR444245