Louisville, KYNCT01638676Now EnrollingIRB Ready

Melanoma Clinical Trial in Louisville, KY

Access cutting-edge melanoma treatment through this phase 1/2 clinical trial at a research site in Louisville. Study-provided care at no cost to qualified participants.

Sponsored by University of Louisville

Quick Self-Assessment

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Expert Care in Louisville

Access melanoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related melanoma treatment provided free

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Check if you qualify for this melanoma clinical trial in Louisville, KY

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Louisville

    Convenient for KY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Louisville site if eligible
  4. 4Begin participation

About This Melanoma Study in Louisville

The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Sponsor: University of Louisville

Who Can Participate

Inclusion Criteria

Male or female patients ≥ 18 years of age;
Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2;
Life expectancy ≥ 3 months;
At least 1 site of radiographically measurable disease by RECIST 1.1
Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing:
Absolute neutrophil count (ANC) ≥ 1.0 x 109/L;
Platelet count ≥ 50 x 109/L;
Hemoglobin ≥ 8 g/dL;
Serum creatinine ≤ 2 x upper limit of normal (ULN)
Total serum bilirubin ≤ 3 x ULN;
Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present.
Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician;
Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year;
Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

Exclusion Criteria

Prior treatment with Vemurafenib;
Known hypersensitivity to Metformin or any of its components;
Previous progression of melanoma while on Metformin;
Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia;
Pregnant, breast-feeding, or refusing double barrier contraception, oral contraceptives, or avoidance of pregnancy measures;
Have any other uncontrolled infection or medical condition that could interfere with the conduct of the study

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Louisville?

Yes, this clinical trial (NCT01638676) has an active research site in Louisville, KY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Melanoma Treatment Options in Louisville, KY

If you're searching for melanoma treatment options in Louisville, KY, this clinical trial (NCT01638676) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Louisville research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced melanoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all melanoma clinical trials near you to find additional studies recruiting in your area.

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