A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma...
MelanomaVaccine adjuvants are compounds used to increase specific immune responses to antigens, but have minimal toxicity or lasting immune effects on their own. This study investigates the use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to Montanide® in study subjects with melanoma in complete clinical remission.
Vemurafenib Plus Cobimetinib Plus PEG-interferon in Advanced Melanoma Patients Harboring the V600BRAF...
MelanomaThe hypothesis of this study is to evaluate the safety and the efficacy of Vemurafenib/PEG-interferon combination and the IFNAR1 upregulation lead by this treatment.
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
Mucosal MelanomaRecurrent Melanoma9 moreThis pilot phase II trial studies how well epacadostat and vaccine therapy work in treating patients with stage III-IV melanoma. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vaccines made from peptides and antigens may help the body build an effective immune response to kill tumor cells. Giving epacadostat with vaccine therapy may be an effective treatment for advanced melanoma.
Phase 2 Study of Ipilimumab in Japanese Advanced Melanoma Patients
MelanomaThe purpose of this study is to assess the safety of Ipilimumab monotherapy in Japanese subjects with advanced melanoma
Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
MelanomaThe primary objective was to estimate the proportion of participants with detectable talimogene laherparepvec deoxyribonucleic acid (DNA) in the blood and urine at any time after administration of talimogene laherparepvec within the first 3 cycles.
IVAC MUTANOME Phase I Clinical Trial
MelanomaClinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma
Bioequivalence & Food Effect Study in Patients With Solid Tumor or Hematologic Malignancies
Hematological NeoplasmsNon-Hodgkin's Lymphoma18 moreThis is a Phase 1, open-label, multicenter, randomized, 2-stage crossover study consisting of 2 phases: Stage I - Pharmacokinetics (Bioequivalence), with an Extension Stage II - Pharmacokinetics (Food Effect) with an Extension This study will enroll approximately 60 subjects in stage I and 60 subjects in stage II with hematologic or solid tumor malignancies, excluding gastrointestinal tumors and tumors that have originated or metastasized to the liver for which no standard treatment exists or have progressed or recurred following prior therapy. Subjects must not be eligible for therapy of higher curative potential where an alternative treatment has been shown to prolong survival in an analogous population. Approximately 23 sites in the US and 2 in Canada will participate in this study.
Trial of Ipilimumab After Isolated Limb Perfusion, in Patients With Metastases Melanoma
In-transit Metastases Melanoma Stage IIIB and IIICIsolated limb perfusion (ILP) results in good response rates for locally advanced melanoma (stage IIIB and IIIC, AJCC 2009). Outcome is influenced by stage of disease, reflecting the aggressiveness of the melanoma. Our objective is to demonstrate at least a doubling of the progression free survival for the patients having an adjuvant treatment by Ipilimumab in this patient population with unfavourable characteristics. PFS ranges from 10-12 months. So at least a doubling of this period would be a clinically highly significant result.
Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in...
CancerMelanomaThis was a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or metastatic Acral lentiginous or cutaneous melanoma. This study evaluated the objective response rate (ORR), progression free survival (PFS), duration of response, overall survival (OS), safety and efficacy, to assess steady state (all subjects) exposure to dabrafenib, dabrafenib metabolites, and trametinib and characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of dabrafenib and trametinib. Enrolled subjects were administered dabrafenib 150 milligram (mg) orally twice daily and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent, or study closure. After treatment discontinuation, subjects were followed for survival and disease progression as applicable.
Safety and Tolerability of Pembrolizumab (MK-3475) + Pegylated Interferon Alfa-2b and Pembrolizumab+...
Renal Cell CarcinomaMelanomaThis study is being done to analyze the safety, tolerability, and efficacy of treatment for advanced melanoma (MEL) and renal cell carcinoma (RCC) using combination regimens of pembrolizumab + pegylated interferon alfa-2b (PegIFN-2b) and pembrolizumab + ipilimumab (IPI). The primary hypothesis is that these combinations will be sufficiently well-tolerated to permit continued clinical investigation.