Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION
Melanoma (Skin)Melanoma1 moreThe trial is looking for new and better ways to treat melanoma, an aggressive type of skin cancer. Having surgery to remove the melanoma will cure the majority of patients with early stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their body. Currently, patients who have been cured of melanoma will have appointments in clinic to check that further disease has not developed or returned and some may also receive regular scans. The trial team has developed a blood test that tells us whether cancer cells are still present or is becoming active after a patient has been 'cured' of melanoma, even if a scan looks normal. The test looks for pieces of DNA in the blood that are known to have come from the cancer, which we call 'circulating tumour DNA', or ctDNA. Patients who have ctDNA in their blood have an extremely high chance of the cancer returning. By using the blood test that we have developed we think that we can identify patients earlier than normal. We think that some of the treatments that are used when melanoma cancer has spread may benefit patients at this earlier stage. We want to see if these patients with ctDNA in their blood, who have a higher risk of their cancer returning or spreading, and receive treatment early have a better response to their cancer compared to those patients who receive treatment when their cancer has returned and it can be seen on a scan. This could mean we would be able to offer patients earlier treatment in the future using just a blood test rather than a scan, while also providing reassurance to those patients that do not have ctDNA in their blood that they do not need treatment and their cancer is not returning.
ITIL-168 in Advanced Melanoma
Advanced Cutaneous MelanomaDELTA-1 is a phase 2 clinical trial to evaluate the efficacy and safety of ITIL-168 in adult subjects with advanced melanoma who have previously been treated with a PD-1 inhibitor. ITIL-168 is a cell therapy derived from a patient's own tumor-infiltrating immune cells (lymphocytes; TILs).
LifeChamps Feasibility Study
Melanoma (Skin)The purpose of this study is to collect data from various sources (PROM / PREM, sensors, journal data) to train AI based models in the LifeChamps digital platform in a pre-pilot, as well as partly implement a pilot/feasibility study to examine the applicability of the digital technology developed in LifeChamps, as well as the usability for patients (cancer survivors) and health care professionals
Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US
MelanomaThis study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy. The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.
Immunostimulating Interstitial Laser Thermotherapy in Malignant Melanoma
MelanomaMalignant MelanomaThermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size. The immunologic response has previously been characterized in breast cancer patients after receiving imILT treatment , and presumed abscopal effects induced by imILT have also been described in a malignant melanoma patient. The purpose of this trial is to investigate the functionality and safety of the imILT treatment method in patients diagnosed with malignant melanoma. The inflammatory process, following on the treatment, will also be described in order to provide a more in depth knowledge of the treatment for this indication. The purpose is also to evaluate efficiency when it comes to local tumor destruction as well as understanding of the subsequent immunological effects. Since immunologically based treatment of malignant melanoma is under intense review with so called "immune checkpoint inhibitors" this trial will also provide valuable information on how imILT, in the future, could be combined with these new and, for some patients, very effective treatment regimens. The treatment method has successfully been used for treatment of patients with breast cancer and malignant melanoma . Treatment of breast cancer patients caused an increase of cytotoxic T lymphocytes in the treated tumor, as well as activated dendritic cells at the tumor border. Regulatory T lymphocytes decreased in the regional lymph nodes. This trial is explorative, prospective, open and non-randomized. Five malignant melanoma patients stage III - IV will be treated in this trial, which is estimated to be carried out during a time period of 12 months.
A Study of Glembatumumab Vedotin as Monotherapy or in Combination With Immunotherapies in Patients...
MelanomaThis study will examine the effectiveness and safety of glembatumumab vedotin as monotherapy or in combination with immunotherapies in patients with advanced melanoma.
Complementary Vaccination With Dendritic Cells Pulsed With Autologous Tumor Lysate in Resected Stage...
Malignant MelanomaAdjuvant Drug Therapy1 moreThis phase II, randomized, open-label trial aims to assess whether the vaccination increase RFS in disease free melanoma patients after surgery. Patients will be randomized between Intradermal Autologous Dendritic Cell Vaccine loaded with autologous tumor lysate or homogenate (6 vaccines every 4 weeks) and observation.
MSB0010445 and Stereotactic Body Radiation Therapy in Advanced Melanoma
MelanomaThis is a Phase 2a, open-label, parallel group, partly randomized dose escalation trial to assess the safety and efficacy of a low dose, an intermediate dose, and high dose MSB0010445 given by intravenous infusion to subjects with advanced (unresectable or metastatic) melanoma in combination with stereotactic body radiation therapy (SBRT).
Ipilimumab Administered to Stage IIIC Stage IV Melanoma After Reg. T Cell Depletion With Denileukin...
Metastatic MelanomaThis is an open-label, clinical efficacy study of Ipilimumab in patients with Stage IIIC and Stage IV melanoma who have recently been treated with Denileukin Diftitox. Approximately 42 patients with radiographically measurable melanoma who have received at least one cycle of Denileukin Diftitox will be enrolled and treated in the study.
T Cell Receptor Immunotherapy Targeting MAGE-A3 for Patients With Metastatic Cancer Who Are HLA-A*01...
Breast CancerCervical Cancer3 moreBackground: The National Cancer Institute (NCI) Surgery Branch has developed an experimental therapy for treating patients with cancer that involves taking white blood cells from the patient, growing them in the laboratory in large numbers, genetically modifying these specific cells with a type of virus (retrovirus) to attack only the tumor cells, and then giving the cells back to the patient. This type of therapy is called gene transfer. In this protocol, we are modifying the patients white blood cells with a retrovirus that has the gene for anti-MAGE-A3 incorporated in the retrovirus. Objective: The purpose of this study is to determine a safe number of these cells to infuse and to see if these particular tumor-fighting cells (anti-MAGE A3 cells) cause tumors to shrink and to be certain the treatment is safe Eligibility: - Adults age 18-66 with cancer expressing the MAGE-A3 molecule. Design: Work up stage: Patients will be seen as an outpatient at the National Institutes of Health (NIH) clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed Leukapheresis: If the patients meet all of the requirements for the study they will undergo leukapheresis to obtain white blood cells to make the anti MAGE-A3 cells. {Leukapheresis is a common procedure, which removes only the white blood cells from the patient.} Treatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the anti MAGE-A3 cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment. Follow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits take up to 2 days.