Is NCT04741997 recruiting in Tampa, FL?

Yes, NCT04741997 is currently recruiting participants at its Tampa, FL location. This melanoma stage iii clinical trial is actively enrolling qualified participants.

How do I join the melanoma stage iii clinical trial in Tampa?

To join this clinical trial in Tampa, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Tampa clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Melanoma Stage III Clinical Trial in Tampa, FL

About This Melanoma Stage III Study in Tampa

The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

Inclusion Criteria

Age ≥ 18 years at the time of informed consent

Histologically confirmed diagnosis of melanoma. Any primary or unknown origin is permitted.

Melanoma must have a BRAFV600 mutation (using a CLIA-validated assay), either stage III (B/C/D) or Stage IV (AJCC 8th edition).

ECOG performance status ≤ 2

Adequate laboratory parameters as well:

a. Hemoglobin ≥ 8 g/dL.

b. Platelets ≥ 75 × 109/L;

c. AST and ALT ≤ 2.5 × ULN; in participants with liver metastases ≤ 5 × ULN;

d. Total bilirubin ≤ 1.5 × ULN and \< 2 mg/dL; OR total bilirubin \>1.5 × ULN with indirect bilirubin \< 1.5 × ULN;

e. Serum creatinine ≤ 2.0 × ULN

Female participants of childbearing potential as described in protocol, must have a negative serum or urine β-HCG test result. Female participants of childbearing potential must agree to use methods of contraception that are highly effective or acceptable, as described in Section 4.3.1. Participants must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy. Male participants must agree to use methods of contraception that are highly effective or acceptable per protocol.

Exclusion Criteria

Participants may have received prior therapy with BRAF and/or a MEK inhibitor if it was completed at least 6 months prior to study enrollment. Patients who had prior disease progression while on BRAF/MEK inhibitor therapy are not eligible. (Progression after stopping treatment is permitted.) Participants may have received prior therapy an anti-PD-1/PD-L1 or CTLA-4 inhibitor.

Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs due to toxicity.

Participants who have had major surgery or radiotherapy ≤ 14 days prior to start of study treatment or who have not recovered from side effects of such procedure.

Participants must be willing to avoid consuming grapefruit, pomegranates, star fruits, Seville oranges or products containing the juice during the study while they are taking encorafenib/binimetinib.

Uncontrolled or symptomatic brain metastases or leptomeningeal carcinomatosis that are not stable, require steroids, are potentially life-threatening or have required radiation within 28 days prior to starting study drug. Patients with previously treated brain metastases may participate provided they are stable (e.g.,without evidence of progression by radiographic imaging for at least 28 days before the first dose of study treatment and neurologic symptoms have returned to baseline).

Impaired cardiovascular function as below:

a. Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 3);

b. presence of uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia

c. Baseline QTcF interval ≥ 500 ms.

Known history of retinal vein occlusion (RVO)

Current use of a prohibited medication (including herbal medications, supplements, or foods), as described in protocol, or use of a prohibited medication ≤ 1 week prior to the start of study treatment.

Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization.

Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization.

Pregnancy or breast feeding.

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 Tampa?

Yes, this clinical trial (NCT04741997) has an active research site in Tampa, FL 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 Stage III Treatment Options in Tampa, FL

If you're searching for melanoma stage iii treatment options in Tampa, FL, this clinical trial (NCT04741997) 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 Tampa research site is actively enrolling participants for this clinical trial. You'll receive care from experienced melanoma stage iii 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 stage iii clinical trials near you to find additional studies recruiting in your area.

Melanoma Stage III Clinical Trial in Tampa, FL

Expert Care in Tampa

IRB Approved

No-Cost Care

Apply for This Tampa Location

Why Participate?

Simple Process