A Study of ONCOS-102 in Combination With Other Novel Immune-therapies in Advanced Treatment-resistant...
MelanomaA Phase 2 study investigating the efficacy and safety of ONCOS-102 alone or in combination with balstilimab (a programmed death receptor-1 [PD-1] inhibitor).
"Dabrafenib and Trametinib in Circulating Free DNA BRAFV600 Mutated Metastatic Melanoma Patients:...
MelanomaThere is evidence from cohort studies and metanalysis that a shift from BRAFWT to BRAF mutated melanomas can occur (Colombino JCO 2012, Valchis EJC 2017). Based on previous studies we expect that 15% of tissue BRAF WT patients treated with anti PD-1 will become circulating free DNA BRAF (CfDNA BRAF) mutation-positive and, at progression, they will be elegible to be treated with dabrafenib/trametinib. We aimed to design a clinical phase II trial in order to evaluate the activity of Dabrafenib and Trametinib in patients with Tissue BRAFWT signature and a molecular shift to circulating free DNA BRAF mutated positive melanomas upon progression to anti PD-1 therapy.
A Phase II Trial of Sunitinib and Nivolumab for KIT-mutated Advanced Melanoma
MelanomaThis will be a phase II trial of the combination of sunitinib and nivolumab in patients with advanced, measurable, metastatic melanoma who harbor mutations in the KIT gene in their tumors. It is a multi-center trial using the FDA-approved doses of both sunitinib and nivolumab. Sunitinib will be provided by Pfizer. Endpoint is RECIST response rate and PFS.
A Pharmacokinetics Study to Investigate the Effect of Ketoconazole on Vemurafenib in Patients With...
Malignant MelanomaNeoplasmsThis open-label, multi-center, three-period, one sequence study will investigate the effect of ketoconazole on the pharmacokinetics of vemurafenib in patients with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Patients will receive a single dose of vemurafenib in Periods A and C and multiple doses of ketoconazole in Periods B and C. Eligible patients will have the option to continue treatment with vemurafenib as part of an extension study (NCT01739764). The anticipated time on study treatment is approximately 19 days.
Internet-based Intervention for Skin Self-Examination in Participants With Increased Risk for Melanoma...
Dysplastic NevusHealth Status Unknown2 moreThis trial studies an internet-based intervention for skin self-examination (SSE) in participants at increased risk for melanoma. Early detection of suspicious growths on the skin can be done by performing regular SSE checks. Using an internet-based intervention, such as mySmartCheck, may help to promote regular, thorough checks on the skin in individuals at increased risk for melanoma.
Vorinostat in Patients With Class 2 High Risk Uveal Melanoma
Uveal MelanomaThis proof-of-concept study will evaluate the ability of vorinostat to induce the transformation of Class 2 uveal melanoma cells into a cell phenotype that resembles normal melanocytes.
Neoadjuvant Use of Talimogene Laherparepvec and BRAF/MEK Inhibitor for Advanced Nodal BRAF Mutant...
Melanoma (Skin)Melanoma Stage IIIb-IVM1a3 moreThis study will investigate whether the use of talimogene laherparepvec (T-VEC) in combination with BRAF/MEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma.
Evaluation of Pathway Modulation by Raf, MEK, & Kinase Inhibitors
Metastatic CancerMelanoma7 moreThis is a pilot study designed to evaluate the cutaneous effect of systemic inhibition of the tyrosine kinase pathway in the presence or absence of solar simulated light exposure. A maximum of 45 subjects will be accrued into the overall study we anticipate approximately 25 patients in the Raf inhibitor group and 10 patients each into the Tyrosine Kinase and MEK inhibitor arms of the study.
Achieving Self-directed Integrated Cancer Aftercare (ASICA) in Melanoma
MelanomaThe ASICA study is looking at how the UK National Health Service (NHS) might use technology in the future to more effectively support people who have been treated for melanoma.
Comparison of Two Strategies for Counseling Skin Examination and Sun Protection in First-degree...
MelanomaScreeningFirst-degree relatives of patients with melanoma have a greater risk of developing melanoma. Patients are advised orally to inform their first-degree relatives that they should protect their skin from UV radiation and ask for a skin examination from a general practitioner or dermatologist. The study will evaluate the effectiveness of a written sheet in addition to the usual oral counselling to increase acceptance of skin examination by the first-degree relatives. If effective, written counselling provided to the patient for relatives should be recommended and generalized.