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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A Phase 2/3 Study of Indoximod or Placebo Plus Pembrolizumab or Nivolumab in Subjects With Unresectable or Metastatic Melanoma


Condition:   Melanoma
Interventions:   Drug: Pembrolizumab + Indoximod;   Drug: Pembrolizumab + Placebo;   Drug: Nivolumab + Indoximod;   Drug: Nivolumab + Placebo
Sponsor:   NewLink Genetics Corporation
Not yet recruiting


Phase I Study of INCB039110 in Combination With Dabrafenib and Trametinib in Patients With BRAF-mutant Melanoma and Other Solid Tumors.


Condition:   Melanoma
Interventions:   Drug: Trametinib;   Drug: Dabrafenib;   Drug: INCB039110
Sponsors:   Massachusetts General Hospital;   Incyte Pharmaceuticals;   Sundry
Not yet recruiting


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


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
Recruiting


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


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


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.
Active, not recruiting


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


Condition:   Melanoma
Intervention:   Drug: regorafenib
Sponsor:   Yonsei University
Recruiting


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


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


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


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


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


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
Active, not recruiting


A Study to Compare Quality of Life and Compliance in Patients Receiving High-dose Interferon Versus Pegylated Interferon in Patients With Surgically Resected Melanoma


Condition:   Melanoma
Intervention:  
Sponsors:   Sanjiv Agarwala, MD;   Merck Sharp & Dohme Corp.
Recruiting


In Vivo Real-time Detection of Circulating Melanoma Cells


Condition:   Melanoma
Intervention:  
Sponsor:   University of Arkansas
Recruiting


Ipilimumab With or Without Talimogene Laherparepvec in Unresected Melanoma


Condition:   Melanoma
Interventions:   Drug: Talimogene laherparepvec;   Drug: Ipilimumab
Sponsor:   Amgen
Active, not recruiting


Interleukin-2 in Metastatic Melanoma


Condition:   Melanoma Metastatic
Intervention:   Drug: Interleukin-2
Sponsor:   Western Regional Medical Center
Terminated


Dacarbazine and Carmustine in Metastatic Melanoma


Condition:   Melanoma Metastatic
Interventions:   Drug: Dacarbazine;   Drug: Carmustine;   Drug: Neulasta
Sponsor:   Western Regional Medical Center
Terminated


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


Dendritic Cells (DC) Vaccine for Metastatic Melanoma


Condition:   Metastatic Melanoma
Intervention:   Biological: Vaccination
Sponsors:   John Kirkwood;   National Institutes of Health (NIH);   National Cancer Institute (NCI)
Terminated


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


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


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


Characterization of the Melanoma-Specific Immune Response


Condition:   Melanoma
Intervention:  
Sponsor:   University of California, Davis
Recruiting


Temozolomide Versus Dacarbazine in Stage IV Metastatic Melanoma (Study P03267)


Condition:   Melanoma
Interventions:   Drug: Temozolomide;   Drug: Dacarbazine
Sponsors:   Merck Sharp & Dohme Corp.;   European Organisation for Research and Treatment of Cancer - EORTC
Completed

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