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345 active trials for Melanoma

A Clinical Performance Study to Validate the Use of Novel Molecular Diagnostic Assays for the Detection of Cancer Biomarkers in Peripheral Blood and Primary Tumor Tissue of Patients With Recurrent/Metastatic HNSCC, Metastatic NSCLC or Metastatic Melanoma

Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment. Liquid biopsy is a non-invasive approach based on the extraction of information through peripheral blood analysis. It makes it possible to characterize the development of a solid tumor in real time, through detailed molecular analysis of circulating genetic material in peripheral blood.

Start: June 2019

Study of CD160, an Activating NK Cell Receptor, in Melanoma: a Potential Therapeutic Target?

Although immunotherapy revolutionized melanoma outcomes over the last 10 years, only 40-50% of patients respond to treatments and 25% develop acquired resistances. Natural Killer (NK) cells naturally recognize and kill tumor cells. However, the immunosuppressive micro-environment generated by the tumor decreases NK cells' killing activity. CD160 is a NK cell receptor identified and characterized in our laboratory. Engagement of the GPI isoform (CD160-GPI) initiates NK cell cytotoxic response. Upon NK cell activation, a transmembrane isoform (CD160-TM) is neo-synthesized which promotes the amplification of activated NK cell cytotoxicity. The aim of this study is to assess the phenotypic profile of advanced stages melanoma patients' NK cells (mainly CD160-TM expression or its induction) and therefore the therapeutic potential of the use of an anti-CD160-TM agonist antibody to boost the NK-dependent mechanism leading to tumor depletion.

Start: September 2020

Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies

The goal of this clinical research study is to find the highest tolerable dose of MGN1703 that can be given in combination with ipilimumab to patients with advanced tumors. The safety of this drug combination will also be studied. This is an investigational study. MGN1703 is not FDA approved or commercially available. It is currently being used for research purposes only. Ipilimumab is FDA approved and commercially available for the treatment of unresectable (cannot be removed with surgery) or metastatic (has spread) melanoma. Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Start: May 2016

Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma

This phase I/II trial studies the side effects of infliximab and vedolizumab and to see how well they work in treating inflammation of the colon (colitis) caused by immune checkpoint inhibitor therapy in patients with cancer of the genital and urinary organs (genitourinary) or melanoma. Monoclonal antibodies, such as infliximab or vedolizumab, may help to treat immunotherapy induced colitis/diarrhea. This study may help to identify the optimal treatment strategy for immune checkpoint inhibitor-related colitis in patients with genitourinary cancer or melanoma.

Start: July 2020

Immune Responses to Autologous Langerhans-type Dendritic Cells Electroporated With mRNA Encoding a Tumor-associated Antigen in Patients With Malignancy: A Single-arm Phase I Trial in Melanoma

This study is being done to see if the investigators can help the immune system to work against melanoma. A dendritic cell is another type of white blood cell. It has most, if not all, of the proteins needed to make T cells work to destroy cancer cells. However, dendritic cells do not normally have the cancer proteins on their surface. The challenge then is to combine the antigens with dendritic cells to make a vaccine. The investigators think that the body's T cells might then react against the tumor and help destroy it. This study will see if altered dendritic cells will make T cells work against tumor cells. The dendritic cells will be made in a lab and will carry the antigens. These cells then will be injected under the skin. In this study, the investigators are trying to help the body make a stronger immune response against the cancer. The patient will get the same kind of dendritic cell vaccine used in the earlier study, but with one major difference. The dendritic cells will contain messenger-RNA (mRNA). Cells use mRNA to make proteins. The mRNA will be put into dendritic cells by a laboratory method called electroporation. The mRNA is never given to the patient directly. This mRNA will help the dendritic cell make a tumor antigen like what the cancer expresses. The dendritic cell can then put this tumor antigen on its surface so that the body could make a stronger immune response against the tumor.

Start: October 2011

Dietary Intervention in Patients With a History of Melanoma

This research trial studies the effects of diet in patients with a history of melanoma. We are studying the impact of 2 different diets; a whole-foods, fiber-rich diet and a ketogenic diet. Participants will be assigned to one of these diets. During this study, participants will be provided all food at no cost for the entire 6-week study. Food can be picked up or shipped to the participant's home. However, participants will need to come into MD Anderson Cancer Center in Houston, TX, for the initial screening visit and for blood tests every 2 weeks during the study.

Start: April 2019

Well-Being and Health-Related Quality of Life in Melanoma Patients During COVID-19 Pandemic

The primary purpose of this study is to gain an understanding of how experiences during the COVID-19 pandemic, regardless of COVID-19 status, may have impacted multiple domains of health-related quality of life and other areas such as COVID-19 specific psychological distress, and disruptions to health care, finances and social interactions. We will also evaluate the extent to which resiliency factors such as social support, perceived benefits under times of stress, and ability to manage stress may buffer associations between COVID-19 experiences and HRQoL. To meet these objectives, we have developed a 10-minute questionnaire that taps into these areas and is based on prior work addressing concerns of other pandemics or national crises. Participants will have previously consented to protocol PA15-0336 and have provided prior lifestyle data. This will allow us to connect the COVID-19 survey data with prior existing data.

Start: June 2020

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.

Start: June 2013

Dose-seeking Study of Pembrolizumab Plus Vemurafenib and Cobimetinib Advanced Melanoma

The study plans to treat patients with pembrolizumab and thus blocking the PD-1/PD-L1 axis would render tumor-infiltrating lymphocytes (TILs) in the tumor parenchyma more functional as a consequence of BRAF inhibition, such that T cell activation by BRAFi would not be dampened by the PD-1/PD-L1 interaction. This combination would reverse dysfunction among T cells in the tumor parenchyma, maximizing T cell mediated immune anti-tumor efficacy. Progression free survival (PFS) with pembrolizumab in KEYNOTE-001 was 57% at 6 months, and 46.4% in the more recently reported phase III trial. PFS with vemurafenib treatment in BRIM-3 was ~50% at 6 months. Combined treatment with pembrolizumab, cobimetinib and vemurafenib for BRAF mutant melanoma is hypothesized to be safe and to improve the PFS compared to these recent historical controls. Because this combination has not yet been tested, and because the primary objective is to assess safety, the investigators are staging accrual in the first phase of the trial. The study aims to accrue up to 30 patients to the mTPI design of this study with the expectation that there will be at least 30 patients treated at RP2D. In case there are less than 30 patients on the RP2D, additional patients will be accrued. Patients will continue to receive treatment with pembrolizumab, vemurafenib and cobimetinib until disease progression or dose limiting toxicity. Patients with treatment response and no dose limiting toxicity may receive treatment with pembrolizumab for up to 24 months.

Start: July 2016

Microbiome Immunotherapy Toxicity and Response Evaluation

This is a observational study to investigate how the microbiome correlates with efficacy and toxicity of immune checkpoint inhibitors in patients with advanced cancer.

Start: July 2020

PDL1 Expression in Cancer (PECan Study).

Measurement of PDL1 expression in cancer to monitor treatment response. A prospective single centre non-randomised exploratory observational study. To determine the baseline level and variability within and between patients and tumour types of PDL1 expression in melanoma and non-small cell lung cancer in immunotherapy naïve patients using [99mTc]-anti-PDL1 SPECT and immunohistochemistry.

Start: August 2020

CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Solid Tumors

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors

Start: February 2018

LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma

This 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

Start: June 2017

Neoadjuvant T-VEC in High Risk Early Melanoma

Despite the recent notable advances in the treatment of advanced melanoma with application of growing immunotherapies, patterns of response and factors resulting in treatment failure are poorly understood. Moreover, the application of these therapeutics has been limited in the neoadjuvant setting, particularly in earlier stage disease, even though this strategy has improved tolerance and efficacy with other modalities of therapy in other cancer types. Survival remains significantly poorer for thicker and ulcerated lesions with T3b and T4 lesions demonstrating less than 50% survival at 5 years independent of other prognostic indicators. Oncolytic viral therapies (OVT) stimulate or suppress the immune system in different ways to stop cancer cells from growing and intra-lesional OVT has demonstrated comparable efficacy and durability with greater tolerability than most effective systemic therapy. Talimogene laherparepvec (T-VEC) is the only phase III approved intra-lesional therapy in melanoma and has demonstrated significantly improved overall response rate (64%) and bystander effect (34% in uninjected lesions) in the therapeutic setting for advanced disease. The investigators propose an open-label, Phase 2 study of talimogene laherparepvec (T-VEC), in the neoadjuvant setting for patients with high-risk, resectable primary and cutaneous melanoma prior to definitive excision. The central hypothesis of this proposal is that neoadjuvant intra-lesional therapy with T-VEC in high risk early stage melanoma will effectively treat local and subclinical distant disease by enhanced immune recognition, immunomodulation of the nodal basin, and still allow for standard of care surgery. The primary aim of this study will be to evaluate for histologic response of melanoma with secondary aim to determine changes in immune response and draining sentinel nodes as well as relationship of immune phenotype to response rate, stage and nodal burden. The investigators plan for thorough exploratory analysis of genetic and microenvironmental changes to identify actionable targets in incomplete as well as evaluation of changes in sentinel burden and subsequent rates of locoregional disease control, recurrence-free survival and overall survival in long term follow up. The investigators predict that histologic clearance of the primary tumor in the surgical specimen will be associated with improved RFS. In summary, the goal of this project is to conduct a phase II study to evaluate efficacy of Talimogene laherparepvec in the neoadjuvant setting for primary invasive melanoma in effort to improve currently poor outcomes for these tumors. This strategy has not yet been explored in early phase disease despite dramatic results seen with neoadjuvant therapeutics in other cancer types and recent clinical studies demonstrating efficacy of this approach in advanced resectable melanoma. Our ability to predict non-responder from responder to immunotherapeutic agents such as T-VEC is not yet defined and the risk of universal exposure to these systemic agents may outweigh the hypothesized benefit given the potential for immune-mediated toxicity as well as associated costs. More importantly, mechanistic dissection of pathways and molecular/immunological signatures of response and resistance offer the promise of a more rational and targeted selection of immunotherapy to maximize benefits and minimize risks. This study would be first in kind to target high earlier stage melanoma in the neoadjuvant setting with a less toxic intra-tumoral immunotherapy with key correlative endpoints regarding immune mechanisms of response.

Start: May 2020

Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases

There is currently an urgent need for low cost and well tolerated intralesional agents for the management of in transit and cutaneous melanoma metastases that are unsuitable for, or resistant to, other therapies. This pilot study will determine whether intralesional injections of the sclerosant polidocanol into intransit and cutaneous melanoma lesions shows promise for efficacy, safety and ease of use that will enable this inexpensive and widely available agent to undergo further evaluation.

Start: May 2020

Camrelizumab Plus Apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma

It is a single-center,exploratory clinical trial aimed to evaluate the objective response rate (ORR) of Camrelizumab combined with apatinib and Temozolomide as First Line Therapy in Advanced Acral Melanoma.

Start: May 2020

An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma

The purpose of this study is to determine whether an investigational immunotherapy Nivolumab, when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or stage IV Melanoma

Start: April 2017

OH2 Injection in Solid Tumors

This phase I study evaluates the safety and efficacy of OH2 as single agent or in combination with Keytruda, an anti-PD-1 antibody, in patients with malignant solid tumors (Melanoma). OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

Start: March 2020

Pembrolizumab and EDP1503 in Advanced Melanoma

This study is being done to determine if orally administered EDP1503 will enhance the response to standard immunotherapy treatment (pembrolizumab) in participants with advanced melanoma. The study will involve initial administration of EDP1503 for a run-in period (2 weeks) followed by administration of both EDP1503 (twice daily) and pembrolizumab (every 3 weeks). Mandatory biopsies are required before starting study treatment and after 2 weeks of EDP1503 dosing.

Start: October 2018

Study in Patients With Unresectable And Metastatic Melanoma: The Optimize Study

This study evaluates the different patterns of care for patients who have unresectable or metastatic melanoma. The dosing, duration, regimen, indication, and treatments will be observed. The survival rate of these patients will also be observed.

Start: July 2015