Is NCT06627244 recruiting in Miami, FL?

Yes, NCT06627244 is currently recruiting participants at its Miami, FL location. This metastatic uveal melanoma clinical trial is actively enrolling qualified participants.

How do I join the metastatic uveal melanoma clinical trial in Miami?

To join this clinical trial in Miami, 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 Miami 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 Miami, FL

Who Can Participate

Inclusion Criteria

Metastatic uveal melanoma, confined mainly to the liver, and documented by pathology review

Serum bilirubin \<2 mg/dl, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x upper limit of normal (ULN)

Mapping angiogram procedure shows radioembolization is feasible and safe to perform

Human leukocyte antigen-A\*02:01(HLA A⁕ 02:01) positive

Patient age ≥ 18 years old

Ability to provide and understand written informed consent

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Patients must have measurable disease or non-measurable disease according to RECIST 1.1 (Eisenhauer et al, 2009).

Exclusion Criteria

Patient with any tumor size \> 8 cm

Total bilirubin \> 1.5 × ULN, except for patients with Gilbert's syndrome, who are excluded if total bilirubin \> 3.0 × ULN or direct bilirubin \> 1.5 × ULN

Clinical laboratory measurements that meet any of the following criteria:

Alanine aminotransferase (ALT) \> 3 × ULN

Aspartate aminotransferase (AST) \> 3 × ULN

Absolute neutrophil count (ANC) \< 1.0 × 10\^9 cells/L

Absolute lymphocyte count \< 0.5 × 10\^9 cells/L

Platelet count \< 75 × 109 platelets/L

Hemoglobin \< 8 g/dL

Angiogram shows vascular shunting which prevents radioembolization

History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies

Patients with clinically significant cardiac disease or impaired cardiac function, including any of the following:

Congestive heart failure (New York Heart Association Class ≥ 3).

Uncontrolled hypertension (consistent findings of systolic blood pressure \[BP\] \> 160 mmHg or diastolic BP \> 110 mmHg).

History of ventricular arrhythmia currently requiring medical treatment.

Uncontrolled atrial fibrillation.

Electrocardiogram (ECG) QT interval corrected for heart rate by Fridericia's method (QTcF) \> 470 msec during screening obtained on triplicate ECGs or known history of congenital prolonged QT syndrome.

Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to screening.

Presence of symptomatic or untreated central nervous system (CNS) metastases or CNS metastases that require doses of corticosteroids within 14 days prior to study treatment Day 1.

Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of Tebentafusp.

Known history of human immunodeficiency virus (HIV) infection. Testing for HIV status is not necessary unless clinically indicated.

Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection.

Malignant disease other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.

Any medical condition that would, in the Investigator's or Sponsor's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results

Patients who received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of the planned first dose of study intervention. The following exceptions are permitted (Section 4.9.1):

Treatment for well-controlled and asymptomatic adrenal insufficiency, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.

Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications).

Premedication for allergy to contrast reagent.

Steroids for management of CNS metastases \> 14 days prior to the planned first dose of study intervention.

To treat asthma or chronic obstructive pulmonary disease exacerbations \> 14 days prior to the planned first dose of study intervention (only short-term oral or IV use in doses \> 12 mg/day prednisone equivalent).

For inhalation in the management of asthma or chronic obstructive pulmonary disease.

Any premedications required per protocol.

Patient with morning cortisol \< lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses). For additional information regarding patients with adrenal insufficiency.

History of interstitial lung disease

History of pneumonitis that required corticosteroid treatment or current pneumonitis

Patients with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn's disease), within 2 years of screening. Note: The following exceptions are permitted:

Managed hypothyroidism (on stable replacement doses)

Asymptomatic adrenal insufficiency (on stable replacement doses) (For additional information regarding patients with adrenal insufficiency.

Resolved childhood asthma/atopy

Well-controlled asthma

Type I diabetes mellitus

Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, tumor biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)

Radiotherapy within 2 weeks of the first dose of study drug, with the exception of palliative radiotherapy to a limited field, such as for the treatment of bone pain or a focally painful tumor mass

Use of hematopoietic colony-stimulating growth factors (eg, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), macrophage colony-stimulating factor (M-CSF)) ≤ 3 weeks prior to start of Tebentafusp. An erythroid-stimulating agent is allowed as long as it was initiated at least 3 weeks prior to the first dose of study treatment and the patient is not red blood cell (RBC) transfusion dependent. For more information on the timing and use of hematopoietic colony-stimulating growth factors during study.

Patient receiving a live or attenuated vaccine(s) ≤ 28 days prior to the first dose of study intervention. Note: Non-live vaccines (including adenoviral and messenger ribonucleic acid (mRNA)-based coronavirus disease-2019 (COVID-19) vaccines) are allowed but are not to be administered for at least 2 weeks before and 3 weeks after start of study treatment and within 24 hours before or after study treatment administration following the first 3 weeks of study treatment.

Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)

Women of childbearing potential (WoCBP) who are sexually active with a non-sterilized male partner, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception during study treatment (defined in Section 4.12), and must agree to continue using such precautions for 6 months after the final dose of Tebentafusp; cessation of birth control after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 4.12.

Male patients must be surgically sterile or use double barrier contraception methods as described in Section 4.12 from enrollment through treatment and for 6 months following administration of the last dose of Tebentafusp.

Prior radioembolization or other regional, liver-directed therapy, including chemotherapy or embolization to same site in the liver

Patients with impaired decision-making capacity.

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 Miami?

Yes, this clinical trial (NCT06627244) has an active research site in Miami, 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 Miami, FL

If you're searching for metastatic uveal melanoma treatment options in Miami, FL, this clinical trial (NCT06627244) 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 Miami 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 Miami, FL

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