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Melanoma clinical trials

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NCT ID: NCT03932253 Suspended - Melanoma Clinical Trials

MEK Inhibitor FCN-159 To Treat Advanced Melanoma With NRAS-aberrant (Ia) and NRAS-mutant (Ib)or NF1-mutant(1b)

Start date: March 21, 2019
Phase: Phase 1
Study type: Interventional

Melanoma is one of the most common cutaneous cancers worldwide. Activating mutations in RAS oncogenes are found in a third of all human cancers and NRAS mutations are found in 15%-20% of melanomas. Acquisition of a functional mutation in NRAS results in activation of the Ras / Raf / MEK / ERK signaling pathway leading to unconstrained cell growth and cell transformation. NRAS mutation status was identified as an independent poor prognostic factor in stage IV melanoma. No drug was approved to treat melanoma patients with NRAS mutation or amplification until now. FCN-159, an oral and potent MEK1/2 inhibitor, has more than 10 folds higher selectivity against activated MEK1 and MEK2 compared with trametinib, and has demonstrated significant antitumor growth inhibition in two patient-derived xenograft (PDX) models with NRAS mutation. Approximately 10%-15% of melanomas is reported to be NF1-mutant. NF1 gene is located in chromosome 17 q11.2 and encodes neurofibromin 1. Neurofibromin 1 is a RAS-specific GTP enzyme-activated protein that converts RAS from the active guanosine triphosphate (GTP) binding state to the inactivated guanosine diphosphate (GDP) binding state and acts as a negative regulatory factor for RAS and its downstream MAPK and PI3K-Akt pathways. Recent treatments of NF1 mutation focus on the downstream of the MAPK pathway, such as MEK kinase. Blocking the MEK kinase can reduce neurofibroma in mice with NF1 mutation and prolong the survival time of mice with malignant peripheral nerve sheath tumor (MPNST) xenograft. In the NF1 mutant monocytic leukemia mouse model, the use of MEK inhibitors can improve mouse survival rate. This is the first in human study to evaluate the safety and anti-tumor activity in patients.

NCT ID: NCT03929029 Active, not recruiting - Melanoma Clinical Trials

Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma

Start date: November 11, 2020
Phase: Phase 1
Study type: Interventional

This research study is studying a new type of personalized neoantigen vaccine (NeoVax) plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for melanoma. The drugs involved in this study are: - Personalized Neoantigen Vaccine - Poly-ICLC (Hiltonol®) - Montanide® - Ipilimumab (Yervoy™) - Nivolumab (Opdivo®)

NCT ID: NCT03928275 Withdrawn - Clinical trials for Cutaneous Metastatic Melanoma

The Response to Intralesional IL-2 and/or BCG Treatment for Cutaneous Metastatic Melanoma

Start date: December 1, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The investigators aim to include 100 local participants over the next 5 years in a two-stage sequential randomized interventional study of intralesional Interleukin-2 (IL-2) and Bacillus Calmette Guerin (BCG) to assess the utility of treating cutaneous metastatic melanoma (CMM).

NCT ID: NCT03927742 Completed - Melanoma (Skin) Clinical Trials

Wearable Device Intervention to Improve Sun Behaviors in Melanoma Survivors

Start date: June 9, 2020
Phase: N/A
Study type: Interventional

Over 5 million new cases of skin cancer are diagnosed in the United States each year, more than all other cancers combined. Most of these cases are caused by excess exposure to ultraviolet radiation from the sun and artificial sources such as indoor tanning. Melanoma, approximately 87,000 of the annual skin cancer cases and one of the more deadly skin cancers, is on the rise. Previous research on these individuals suggests that while some change how much time they spend in the sun and adopt ways to protect themselves when in the sun, many do not. In our previous study, we found that 20% of melanoma survivors reported a sunburn in the past year and 10% intentionally went outside for a tan, both strong indicators of inappropriate sun exposure. Melanoma survivors are at high risk of second melanomas, making it critical that they spend less time in the sun or take actions to protect themselves when they are in the sun. No studies to date have investigated technology-based strategies in melanoma survivors to improve sun exposure and protection behaviors. This project will test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will increase sun protection behaviors in melanoma survivors. The use of wearable technology devices (e.g., Fitbit) has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. We will test the technology device versus a similar control device in 368 melanoma survivors and compare sun protection behaviors between the two groups. This project has the potential to identify a strategy that could significantly lower the number of melanoma survivors who go on to have a second melanoma diagnosis. Importantly, this easy to use technology could also be utilized by survivors' family members, who are also at higher risk for melanoma, and the general population as a means to reduce risk of all forms of skin cancer.

NCT ID: NCT03925350 Recruiting - Metastatic Melanoma Clinical Trials

Efficacy and Safety Study of Niraparib in Melanoma With Genetic Homologous Recombination (HR) Mutation

Start date: March 20, 2019
Phase: Phase 2
Study type: Interventional

This open-label phase II trial studies how well niraparib works in treating patients with advanced, metastatic melanoma with the homologous recombination (HR) pathway gene mutation / alteration. Niraparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The trial is designed to assess the efficacy and safety of niraparib in patients with HR mutation/ alteration whose disease progressed on prior immunotherapy and/or BRAF-targeting therapy.

NCT ID: NCT03922880 Completed - Uveal Melanoma Clinical Trials

Study of Immunotherapy Plus ADI-PEG 20 for the Treatment of Advanced Uveal Melanoma

Start date: April 16, 2019
Phase: Phase 1
Study type: Interventional

This study is measuring the safety of the study drug, ADI-PEG 20, combined with immunotherapy drugs nivolumab and ipilimumab in treating patients with advanced uveal melanoma.

NCT ID: NCT03917069 Recruiting - Advanced Melanoma Clinical Trials

Nab-PCE vs PC for MM After Failure of Anti-PD-1

Start date: March 23, 2019
Phase: Phase 2
Study type: Interventional

This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin - Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin - endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.

NCT ID: NCT03915678 Recruiting - Pancreatic Cancer Clinical Trials

Atezolizumab Combined With BDB001 AnD Immunogenic Radiotherapy in Patients With Advanced Solid Tumors

AGADIR
Start date: March 31, 2021
Phase: Phase 2
Study type: Interventional

Basket trial concept to independently and simultaneously assess the effects of the association of atezolizumab + BDB001 + radiotherapy in multiple solid tumors.

NCT ID: NCT03913923 Active, not recruiting - Melanoma Clinical Trials

Study of Efficacy and Safety of BCD-217 (Anti-CTLA-4 and Anti-PD-1) Followed By BCD-100 (Anti-PD-1) Versus BCD-100 Monotherapy as First-Line Treatment in Patients With Unresectable or Metastatic Melanoma

OBERTON
Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter randomized double-blind placebo-controlled phase II clinical trial. The purpose of this trial is to evaluate efficacy and safety of therapy consisting of BCD-217 (fixed dose combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies) and sequential BCD-100 (anti-PD-1 monoclonal antibody) versus BCD-100 monotherapy as first-line treatment in patients with treatment-naïve unresectable or metastatic melanoma.

NCT ID: NCT03911869 Terminated - Brain Metastases Clinical Trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

POLARIS
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.