A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type...
Metastatic MelanomaThis study will evaluate the efficacy and safety of cobimetinib plus atezolizumab in participants with BRAFV600 wild-type melanoma with central nervous system (CNS) metastases and of cobimetinib plus atezolizumab and vemurafenib in BRAFV600 mutation-positive melanoma patients with CNS metastases.
AI Augmented Training for Skin Specialists
MelanomaSkin CancerBackground: The worldwide incidence of skin cancer has been rising for 50 years, in particular the incidence of malignant melanoma has increased approx. 2-7% annually and is the most common cancer amongst Danes aged 15-34. Currently there is a significant amount of misdiagnosis of skin cancer and mole cancer, and most excised skin lesions are benign. Previous studies have shown that there is no significant increase in doctors diagnostic accuracy during the first 6 years of clinical work. The resources spend on healthy people could be put to better use, if the Benign-Malignant Ratio could be lowered. This could potentially be done by better educating the doctors during their everyday clinical practice. Aim: The aim of this study is to investigate the dose/response effect of an AI augmented training and clinical feedback on the diagnostic accuracy of skin cancer and clinical decisions among doctors from specialized skin cancer centers. Research question: How much specialized doctors need to train before their diagnostic accuracy and clinical decisions change?
Prolgolimab 250 mg Q3W in Patients With Unresectable or Metastatic Melanoma
Unresectable or Metastatic MelanomaMulticentre, single-arm, open-label efficacy, pharmacokinetics, and safety study to demonstrate non-inferiority of prolgolimab 250 mg every 3 weeks versus historical data for prolgolimab 1 mg/kg every 2 weeks in patients with unresectable or metastatic melanoma, as well as collecting pharmacokinetics and safety data. The study is conducted under the same conditions as the previously conducted study BCD-100-2/MIRACULUM. This means that this Study No. BCD-100-8/FLAT has identical parameters such as: selection criteria for subjects in the study, defining the population, research centers, procedures for evaluating effectiveness and safety, permitted prior and concomitant therapy of the underlying disease.
Pembrolizumab and All-Trans Retinoic Acid Combination Treatment of Advanced Melanoma
Stage IV MelanomaStage III Melanoma1 moreThis is a Phase I/Ib investigator-initiated open label of the combination of VESANOID and pembrolizumab treatment.
LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma
MelanomaThis research study is studying a combination of targeted therapies as a possible treatment for advanced melanoma that was found to have a BRAF V600E or BRAF V600K genetic mutation The interventions involved in this study are: LY3022855 Vemurafenib Cobimetinib
A Phase Ib Study of LXH254-centric Combinations in NSCLC or Melanoma
Non-Small Cell Lung CancerMelanomaTo characterize safety and tolerability and identify a recommended dose and regimen for the LXH254 in combination with LTT462 or trametinib or ribociclib.
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced Melanoma...
MelanomaThe purpose of this study is to determine whether relatlimab in combination with nivolumab is more effective than nivolumab by itself in treating unresectable melanoma or melanoma that has spread.
A Randomized, Controlled, Multi-center, Phase III Clinical Study to Investigate Recombinant Humanized...
Metastatic MelanomaUnresectable MelanomaThis is one phase III, randomized, open-label study in comparison of JS001 with dacarbazine as the 1st-line therapy for adult (≥18 years) subjects with unresectable or metastatic melanoma. The subjects will be 1:1 randomized and stratified in accordance with acral lentiginous melanoma and M stage (M0vsM1a/M1bvsM1c). Using standard dose and dose interval, the subjects will be given JS001 240mg intravenously, once every two weeks, or dacarbazine 1000mg/m2, d1, intravenously, once every three weeks. One cycle of therapy is 6 weeks (3 doses of JS001 or 2 doses of dacarbazine per cycle).
A Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics...
Advanced Solid Tumors (Part A/B/C/D)Non-small Cell Lung Cancer (Part E)6 moreThis dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IPI-549 monotherapy and IPI-549 in combination with nivolumab in subjects with advanced solid tumors.
Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard...
Advanced Malignant Solid NeoplasmClinical Stage III Cutaneous Melanoma AJCC v827 moreThis phase Ib trial studies the side effects and best dose of selinexor when given together with several different standard chemotherapy or immunotherapy regimens in treating patients with malignancies that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Selinexor may stop the growth of cancer cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Studying selinexor with different standard chemotherapy or immunotherapy regimens may help doctors learn the side effects and best dose of selinexor that can be given with different types of treatments in one study.