Melanoma Clinical Trials

Showing 1-10 of 10 items
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  • Nivolumab and Ipilimumab With or Without Sargramostim in Treating Patients With Stage III-IV Melanoma That Cannot Be Removed by Surgery
  • This randomized phase II/III trial studies the side effects and best dose of nivolumab and ipilimumab when given together with or without sargramostim and to see how well they work in treating patients with stage III-IV melanoma that cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab and nivolumab, may kill tumor cells by blocking blood flow to the tumor, by stimulating white blood cells to kill the tumor cells, or by attacking specific tumor cells and stop them from growing or kill them. Colony-stimulating factors, such as sargramostim, may increase the production of white blood cells. It is not yet known whether nivolumab and ipilimumab are more effective with or without sargramostim in treating patients with melanoma.
  • Diagnoses: Melanoma, Cutaneous Skin Cancer
  • Status: Recruiting
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  • RTA 408 Capsules in Patients With Melanoma - REVEAL
  • Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other therapies, however, approved therapies are rarely curative. It is now well accepted that tumors are able to evade detection and eradication by the immune system, even though many tumor types, particularly melanoma, are capable of eliciting a strong immune response (Swann, 2007). Substantial mechanistic work in recent years has revealed the key role of myeloid-derived suppressor cells (MDSCs) in masking cancer cells from the immune system, promoting both tumor progression and resistance to cancer immunotherapy. The immune-suppressive effect of MDSCs is dependent on the production of reactive oxygen species (ROS) and reactive nitrogen species (RNS). High levels of these reactive molecules and their by-products, such as nitrotyrosine, have been correlated with poor clinical outcomes in melanoma. Currently available melanoma therapies do not target MDSCs. In animals, RTA 408 significantly reduces tumor nitrotyrosine burden, inhibits the activity of MDSCs, and augments T-cell anticancer activity at relevant doses. Thus, through inhibition of MDSC activity and suppression of tumor ROS/RNS, RTA 408 may work in combination with T-cell-activating therapeutics such as ipilimumab to enhance the natural immune anticancer response. RTA 408 also has direct anticancer effects via inhibition of NF-kappa B. Chronic activation of NF-kappa B is associated with tumor progression, metastasis, and resistance to therapy. This proposed study is designed to assess the safety, efficacy, pharmacodynamics, and pharmacokinetics of RTA 408 in combination with ipilimumab or nivolumab in patients with unresectable or metastatic melanoma. In this open-label, multicenter, dose-escalation, Phase 1b/2 study, patients who qualify will receive RTA 408 at the assigned dose level in combination with ipilimumab or nivolumab. Patients will receive RTA 408 orally once daily for 1 week prior to initiation of ipilimumab or nivolumab. For patients treated with ipilimumab , the run-in period will be followed by RTA 408 orally once daily in combination with ipilimumab administered at Weeks 1, 4, 7, and 10. After Week 10, patients will receive maintenance treatment with RTA 408 alone once daily. For patients treated with nivolumab, the run-in period will be followed by RTA 408 orally once daily in combination with nivolumab administered approximately every two weeks as clinically indicated. Each patient will continue at the assigned RTA 408 dose level until disease progression occurs, toxicity requiring discontinuation from study drug (i.e., RTA 408) is experienced, the patient has completed approximately 72 weeks of treatment, the patient is discontinued from the study drug for another reason, or the patient withdraws consent. Patients will return 4 weeks after RTA 408 treatment completion for a follow-up visit. The starting RTA 408 dose level for the first dose-escalation cohort in this study has been selected based on available safety and pharmacodynamic data from a Phase 1 study of RTA 408 (NCT02029729). Subsequent cohorts will be enrolled at dose levels based on available safety and PD data from this study, but they will not be greater than 2-fold above the prior dose level. Phase 1b (dose-escalation): In the phase 1b/2 portion of this study, 12 patients will be enrolled in each dose cohort, with six patients administered RTA 408 plus ipilimumab and the remaining six administered rTA 408 plus nivolumab. Subsequent cohorts will assess escalating the doses of RTA 408 administered in combination with ipilimumab or nivolumab. Dose escalation decisions will be based on ongoing review of all available safety information for enrolled patients. Phase 2: The Phase 2 portion of the study may include separate expansion cohorts consisting of patients treated with either of the combination therapies. Each expansion cohort will include an additional 24 patients enrolled at the selected Phase 2 dose level to achieve a total of 30 patients at that RTA 408 dose in combination with ipilimumab or nivolumab.
  • Diagnoses: Melanoma
  • Status: Recruiting
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  • A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma
  • This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the participant's own melanoma. It is known that melanomas have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the melanoma to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.
  • Diagnoses: Melanoma
  • Status: Recruiting
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  • Ipilimumab With or Without Dabrafenib, and/or Trametinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
  • This randomized phase I trial studies the side effects and best way to give ipilimumab with or without dabrafenib and/or trametinib in treating patients with melanoma that is metastatic or cannot be removed by surgery. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether ipilimumab works better with or without dabrafenib and/or trametinib in treating melanoma.
  • Diagnoses: Melanoma
  • Status: Recruiting
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  • Dendritic Cell Activating Scaffold in Melanoma
  • This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma. The purpose of this study is to determine if it is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects. Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.
  • Diagnoses: Melanoma
  • Status: Recruiting
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Showing 1-10 of 10 items
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