Is NCT07276386 recruiting in Tampa, FL?

Yes, NCT07276386 is currently recruiting participants at its Tampa, FL location. This metastatic uveal melanoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic uveal melanoma 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.

Metastatic Uveal Melanoma Clinical Trial in Tampa, FL

About This Metastatic Uveal Melanoma Study in Tampa

This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\*02:01-positive patients.

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Who Can Participate

Inclusion Criteria

Patient is ≥18 years of age on the day of signing informed consent.

ECOG performance status of 0 or 1.

Histologically or cytologically confirmed liver metastasis of uveal melanoma.

HLA-A\*02:01 positive status.

Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver.

Patient deemed suitable for PHP and tebentafusp.

Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.

Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Male patients of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study therapy through 150 days after the last dose of study therapy. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.

Limited extrahepatic disease would be allowed initially, that can be treated with stereotactic body radiation therapy (SBRT) or surgical resection prior to the start of tebentafusp. This concept is similar to the FOCUS trial - definition of "treatable" limited disease at the discretion of the PI.

Ability to provide and understand written informed consent prior to any study procedures.

Exclusion Criteria

Life expectancy of less than 6 months.

More than 50% of the liver volume replaced by tumor as measured by MRI.

Extrahepatic disease as measured by CT of thorax abdomen and pelvis. (See inclusion criteria #10 above for limited treatable extrahepatic disease.)

History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease that precludes the use of general anesthesia.

History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia.

Patients who are unable to undergo general anesthesia for any reason.

Reduced renal function defined as Serum Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockcroft and Gault formula.

Reduced hepatic function (defined as AST, ALT, bilirubin\>2.5\*ULN and PT-INR\>1.5) or medical history of liver cirrhosis (Child-Pugh Class B or C) or evidence of portal hypertension by history, endoscopy or radiology.

Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L.

Use of live vaccines four weeks before the last study treatment.

History of severe reactions to melphalan, heparin or iodine contrast. Iodine contrast reaction history patients permitted if patient will be treated with pre-meds, or if still problematic, treating physician may switch to MRI TAP.

Known human immunodeficiency virus (HIV) infection, acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.

Active autoimmune disease or a documented history of autoimmune disease requiring active systemic immunosuppressive treatment. Type-1 diabetes, atopic dermatitis, and hypothyroidism are exceptions to this.

A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.

Concomitant therapy with any other anti-cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications (other than physiologic (i.e., \>10 mg) doses of steroids or as specified in exclusion #14) or use of other investigational drugs.

Has a known additional malignancy that is progressing or requires active treatment.

Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 150 days after the last dose of study drug.

A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate in the opinion of the treating investigator.

Previous treatment with PHP or tebentafusp.

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 (NCT07276386) 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.

Metastatic Uveal Melanoma Treatment Options in Tampa, FL

If you're searching for metastatic uveal melanoma treatment options in Tampa, FL, this clinical trial (NCT07276386) 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 metastatic uveal 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 metastatic uveal melanoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Uveal Melanoma Clinical Trial in Tampa, FL

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