Improving Patient and Caregiver Understanding of Risks and Benefits of Immunotherapy for Advanced...
Stage IV MelanomaAdvanced Lung Cancer20 moreThe purpose of this study is to refine and pilot test educational material developed to educate and support patients receiving immunotherapy for advanced cancer. The intervention is an educational video and question prompt list (QPL) to promote communication between patients, caregivers, and the oncology team about the risks and benefits of immunotherapy.
Testing Pembrolizumab Versus Observation in Patients With Merkel Cell Carcinoma After Surgery, STAMP...
Pathologic Stage I Merkel Cell Carcinoma AJCC v8Pathologic Stage II Merkel Cell Carcinoma AJCC v81 moreThis phase III trial studies how well pembrolizumab works compared to standard of care observation in treating patients with stage I-III Merkel cell cancer that has been completely removed by surgery (resected). 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.
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic ConditionsHealthy Volunteers3 moreBackground: - Skin disease can have many causes. It can have widespread consequences, and in rare cases can lead to death. Researchers want to determine the causes of various types of skin diseases and find a way to treat them. Objectives: - To determine the causes of various skin diseases and find ways to treat them. Eligibility: People ages 2 and older who have: A skin disease or at risk of developing a skin disease OR A family member of persons with a skin disease Healthy volunteers ages 2 and older Design: Participants will be screened under a separate protocol. Participants may take a survey about how their skin condition affects their quality of life. Participants will have a medical history and a physical exam including a detailed skin exam. Pictures will be taken of their skin to document any skin disease. Participants will have specimens collected. This may include: Several teaspoons of blood taken at each visit Stool samples Nail and body fluid (like saliva) samples Cheek swabs. The inside of the cheek will be scraped for about a minute in each direction to collect cells. Collection of skin samples with: A swab (like a Q-tip) Gently scraping skin to remove the outer layers of cells Applying and removing 1-inch pieces of tape Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time. An area of skin will be numbed with an injection. A piece of skin the size of a pencil eraser will be removed using a small instrument. A flat scar usually develops at the biopsy site.
French National Database of Rare Dermatological Cancers
Adnexal Tumor of SkinMerkel Cell Carcinoma1 moreMerkel cell carcinoma, advanced basal cell carcinoma requiring systemic treatment, and cutaneous adnexal carcinomas are 3 types of rare skin cancers for which much remains unknown in terms of natural behavior, prognosis, treatment and outcomes. CARADERM is a French prospective national cohort enrolling patients with either one of these 3 tumor types, whose objectives are : to provide epidemiological, clinical and socio-economic characteristics of patients to identify new clinical or epidemiological prognostic factors for these rare cancers to evaluate the impact of various treatments on outcomes
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors...
Solid TumorsMycosis Fungoides6 moreThis is a multicenter, open-label, phase 1 study conducted to test intratumoral injections of TTI-621 in subjects that have relapsed and refractory percutaneously accessible solid tumors or mycosis fungoides. The study will be performed in two different parts. Part 1 is the Dose Escalation phase and Part 2 is the Dose Expansion phase. The purpose of this study is to characterize the safety profile of TTI-621 and to determine the optimal dose and delivery schedule of TTI-621. In addition, the safety and antitumor activity of TTI-621 will be evaluated in combination with other anti-cancer agents or radiation.
Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell...
Advanced or Metastatic Merkel Cell CarcinomaAdvanced or Metastatic Cutaneous Squamous Cell Carcinoma3 moreThis is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.
Safety and Efficacy of XmAb18087 ± Pembrolizumab in Advanced Merkel Cell Carcinoma or Extensive-stage...
Merkel Cell CarcinomaSmall Cell Lung CancerThis is a Phase 1b/2, multiple-dose study designed to describe safety and efficacy, and to assess PK and immunogenicity of XmAb18087 monotherapy and in combination with pembrolizumab in participants with metastatic Merkel cell (MCC) or locoregional MCC that has recurred after locoregional therapy with surgery and/or radiation therapy, and mAb18087 monotherapy in participants with extensive-stage small cell lung cancer (SCLC) that has progressed after standard therapies. This study was terminated by the sponsor. No participants enrolled in Part B.
F16IL2 Plus Paclitaxel in Metastatic Merkel Cell Carcinoma
Merkel Cell CarcinomaThere is no standard treatment for Merkel cell carcinoma(MCC), as no randomized trials have been conducted to establish standard of care. Despite a sizable number of objective responses induced by combination cyototoxic chemotherapy, a prolongation of patients overall survival has never been demonstrated. This open-label, randomized, double-arm, multi-centre, phase II study of F16IL2 in combination with paclitaxel versus paclitaxel monotherapy, proposes to test the therapeutic efficacy of F16IL2 plus paclitaxel in patients with metastatic Merkel cell carcinoma, who are not amenable to surgery. A total of 90 patients with Merkel cell carcinoma will be enrolled and treated during the study; 45 patients will receive the combination treatment of F16IL2 and paclitaxel (Arm A), and 45 patients will receive paclitaxel monotherapy (Arm B).
Cabozantinib in Recurrent/Metastatic Merkel Cell Carcinoma
Merkel Cell CarcinomaSkin CancerThis is an open-label, non-randomized, phase 2 study to assess the feasibility of using cabozantinib in recurrent/metastatic Merkel Cell Carcinoma patients that progressed after platinum-based therapy.
TiTAN-1: Safety, Proliferation and Persistence of GEN-011 Autologous Cell Therapy
MelanomaNon-small Cell Lung Cancer7 moreTiTAN-1 is a first-in-human study of GEN-011, an experimental treatment being evaluated in adult patients with advanced cancer. GEN-011 is a T cell therapy made specific to each patient, using the patient's own circulating immune cells. First, Genocea confirms which cancer proteins are recognized already by each patient's T cells using ATLAS™. Then, immune cells that recognize these cancer proteins are multiplied many times (a process called PLANET™) to create a personalized GEN-011 cell therapy, which is given back to the patient in one or more intravenous (IV) infusions.