Melanoma

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Melanoma Clinical TrialsGeneral Purpose:

Melanoma is a highly-malignant type of skin cancer that will affect over 76,000 individuals in the United States in 2012. If you have been diagnosed with melanoma, you may be interested in pursuing melanoma clinical trials in order to gain access to cutting-edge treatment options that might prove to be more effective than conventional therapies.

If you have not been diagnosed but are at an increased risk of melanoma due to family history, genetic characteristics (e.g., fair skin), high lifetime cumulate exposure to sunlight, or other risk factors, you may be interested in volunteering for a clinical trial designed to evaluate new methods of preventing melanoma.

Regardless of what prompted your search, rest assured that there are numerous melanoma-focused clinical trials currently underway, all of which are designed to gain a better understanding of the disease and discover more effective ways to prevent and treat it.

What Will Melanoma Clinical Trials Be Like?

When participating in a melanoma clinical trial, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Some of the following tests and procedures may be used during melanoma clinical trials:

  • Physical exam
  • Detailed personal history of sun exposure and exposure to artificial sources of Melanoma Clinical Trialsultraviolet (UV) radiation, such as tanning beds.
  • Detailed family history of melanoma and other cancer.
  • Detailed history of medication use, current and prior, to document exposure to drugs that increase sensitivity to sunlight or suppress the immune system.
  • Detailed history of dermatologic procedures, such as mole removals or prior scarring or other trauma to the skin.
  • Biopsy
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.

Typical Melanoma Clinical Trial Protocol:

Current melanoma-focused research is devoted to finding new and better ways to treat melanoma and prevent it from spreading to other sites of the body. In addition, since most Melanoma Clinical Trialsskin cancers can be prevented, a great deal of research centers on new and more effective ways to educate the public about the importance of sun protection, as well as the usefulness of regular skin exams. Possible examples of melanoma clinical trials include the following:

  • A study designed to conduct genetic testing among healthy individuals with a family history of melanoma in order to determine the frequency of specific gene mutations known to increase an individual’s risk of developing melanoma.
  • A study designed to investigate if early testing of lymph node DNA can help to identify melanomas that have begun to spread and better target which patients can benefit from further treatment.
  • A clinical trial that compares the use of standard chemotherapy alone versus standard chemotherapy plus a targeted therapy that works to boost the body’s natural immune response to melanoma cells to determine a) which treatment is more effective and b) if one produces more side effects than the other.
  • A clinical trial to determine if a newly-developed anti-melanoma vaccine given to patients with advanced melanoma can help to increase the amount of the tumor that shrank in response to standard chemotherapy and the length of time before it starts to grow again.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug Melanoma Clinical Trialscompared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms Related to Melanoma:

“melanoma treatment,” “melanoma chemotherapy,” “melanoma radiation therapy,” “melanoma management,” “melanoma surgery,” “advanced melanoma,” “melanoma screening,” “metastatic melanoma,” “melanoma genetics,” “melanoma family history,” and “melanoma symptoms.”

Current Search Term:

“Melanoma”

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LY3022855 With BRAF/MEK Inhibition in Patients With Melanoma


Condition:   Melanoma
Interventions:   Drug: LY3022855;   Drug: Vemurafenib;   Drug: Cobimetinib
Sponsors:   Dana-Farber Cancer Institute;   Eli Lilly and Company
Not yet recruiting - verified April 2017


SAbR Plus Ipilimumab Plus Nivolumab in Metastatic Melanoma Patients


Conditions:   Melanoma;   Metastatic Melanoma
Interventions:   Radiation: SAbR;   Drug: Ipilimumab;   Drug: Nivolumab
Sponsor:   University of Texas Southwestern Medical Center
Not yet recruiting - verified April 2017


Tracing Dissemination of Melanoma Cells in Healthy Tissues


Condition:   Melanoma
Intervention:   Procedure: Melanoma and peritumoral skin excision
Sponsors:   Assistance Publique - Hôpitaux de Paris;   Institut National de la Santé Et de la Recherche Médicale, France
Not yet recruiting - verified July 2016


Pharmacodynamics Study of MRX34, MicroRNA Liposomal Injection in Melanoma Patients With Biopsy Accessible Lesions


Condition:   Melanoma
Interventions:   Drug: MRX34;   Drug: Dexamethasone
Sponsor:   Mirna Therapeutics, Inc.
Withdrawn - verified July 2016


Prospective Melanoma Database


Condition:   Melanoma
Intervention:   Other: clinical biological data collection on melanoma
Sponsor:   Institut Claudius Regaud
Recruiting - verified July 2016


BGB324 in Combination With Pembrolizumab or Dabrafenib/Trametinib in Metastatic Melanoma


Condition:   Melanoma
Interventions:   Drug: BGB324+pembrolizumab;   Drug: BGB324+dabrafenib and trametinib;   Drug: pembrolizumab;   Drug: dabrafenib and trametinib
Sponsors:   Haukeland University Hospital;   BerGenBio ASA
Recruiting - verified January 2017


A Clinical Trial of Patients With Melanoma


Condition:   Melanoma
Interventions:   Drug: Digoxin Combination;   Drug: Dabrafenib;   Drug: Trametinib
Sponsor:   University of Texas Southwestern Medical Center
Recruiting - verified November 2016


A Phase 3 Study of Pembrolizumab + Epacadostat or Placebo in Subjects With Unresectable or Metastatic Melanoma (Keynote-252 / ECHO-301)


Condition:   Melanoma
Interventions:   Drug: pembrolizumab + epacadostat;   Drug: pembrolizumab + placebo
Sponsors:   Incyte Corporation;   Merck Sharp & Dohme Corp.
Recruiting - verified April 2017


Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma


Condition:   Malignant Melanoma
Intervention:  
Sponsor:   Universitair Ziekenhuis Brussel
Recruiting - verified September 2016


Study Assessing Two Models of Hypofractionated Protontherapy on Large Choroidal Melanomas


Condition:   Melanoma
Intervention:   Radiation: Protontherapy
Sponsor:   Centre Antoine Lacassagne
Recruiting - verified June 2016


Diagnostic Imaging Study for the Melanoma Advanced Imaging Dermatoscope (mAID)


Condition:   Melanoma
Intervention:  
Sponsors:   Daniel Gareau;   Oregon Health and Science University;   University of California, Irvine
Recruiting - verified August 2016


Melanoma Perception and Health Literacy in People of Color


Condition:   Melanoma
Interventions:   Behavioral: ABCDEs of Melanoma Skin Cancer;   Behavioral: ABCDEs of Melanoma
Sponsor:   Northwestern University
Completed - verified November 2016


Regorafenib, C-kit Mutated Malignant Melanoma, 2nd Line Therapy


Condition:   Melanoma
Intervention:   Drug: regorafenib
Sponsor:   Yonsei University
Recruiting - verified January 2017


Ipilimumab and All-Trans Retinoic Acid Combination Treatment of Stage IV Melanoma


Condition:   Melanoma
Interventions:   Drug: All-Trans Retinoic Acid;   Drug: Ipilimumab
Sponsor:   University of Colorado, Denver
Active, not recruiting - verified February 2017


Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients


Condition:   Melanoma
Interventions:   Drug: Dabrafenib;   Drug: Trametinib;   Drug: Metformin
Sponsors:   James Graham Brown Cancer Center;   University of Louisville
Recruiting - verified November 2016


LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma


Condition:   Melanoma
Interventions:   Drug: LGX818;   Drug: MEK162;   Drug: LEE011;   Drug: BGJ398;   Drug: BKM120;   Drug: INC280
Sponsor:   Array BioPharma
Active, not recruiting - verified March 2017


Treatment of Advanced Melanoma With MK-3475 and Peginterferon


Condition:   Melanoma
Interventions:   Drug: MK-3475;   Drug: Peginterferon alfa-2b
Sponsors:   Hassane M. Zarour, MD;   Merck Sharp & Dohme Corp.;   Melanoma Research Alliance
Recruiting - verified July 2016


A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma


Condition:   Melanoma
Interventions:   Biological: Poly-ICLC;   Biological: Peptides
Sponsor:   Patrick Ott, MD
Recruiting - verified September 2016


In Vivo Real-time Detection of Circulating Melanoma Cells


Condition:   Melanoma
Intervention:  
Sponsor:   University of Arkansas
Recruiting - verified August 2016


Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma


Condition:   Melanoma
Interventions:   Drug: Talimogene laherparepvec plus ipilimumab;   Drug: Ipilimumab
Sponsor:   Amgen
Active, not recruiting - verified February 2017


A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients


Condition:   Melanoma
Interventions:   Drug: Vemurafenib;   Drug: Metformin
Sponsors:   James Graham Brown Cancer Center;   University of Louisville
Recruiting - verified November 2016


Sun Exposure and Melanoma in Agricultural Workers


Condition:   Melanoma
Intervention:  
Sponsor:   National Cancer Institute (NCI)
Completed - verified January 25, 2017


The Use of Dendritic Cell/Tumor Hybridomas as a Novel Tumor Vaccine in Patients With Advance Melanoma


Condition:   Metastatic Melanoma
Intervention:   Biological: DC/tumor fusion vaccine
Sponsors:   Beth Israel Deaconess Medical Center;   Genzyme, a Sanofi Company
Completed - verified March 2017


Pilot hu14.18-IL2 in Resectable Recurrent Stage III or Stage IV Melanoma


Condition:   Melanoma
Interventions:   Drug: hu14.18-IL2;   Drug: hu14.18-IL2
Sponsors:   University of Wisconsin, Madison;   National Cancer Institute (NCI);   EMD Serono
Active, not recruiting - verified June 2016


Vaccination Plus Ontak in Patients With Metastatic Melanoma


Condition:   Melanoma
Interventions:   Drug: 4-peptide melanoma vaccine;   Drug: 4-peptide melanoma vaccine plus Ontak;   Drug: ontak
Sponsors:   University of Chicago;   Eisai Inc.
Active, not recruiting - verified August 2016

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