Is NCT06246149 recruiting in Lake Success, NY?

Yes, NCT06246149 is currently recruiting participants at its Lake Success, NY location. This uveal melanoma clinical trial is actively enrolling qualified participants.

How do I join the uveal melanoma clinical trial in Lake Success?

To join this clinical trial in Lake Success, 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 Lake Success 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.

Uveal Melanoma Clinical Trial in Lake Success, NY

About This Uveal Melanoma Study in Lake Success

At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence following treatment of the primary tumour. Observation is currently the standard of care in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall survival in patients with metastatic uveal melanoma in a randomized trial. Based on the results in the advanced setting, it is hypothesized that treatment with tebentafusp may reduce the risk of development of disease recurrence.

Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Who Can Participate

Inclusion Criteria

Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy

Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks )

High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site.

ECOG performance status of 0 or 1

18 years or older

HLA-A\*02:01 positivity by local assessment

No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization

Adequate organ function

Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks

Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.

For patients of childbearing / reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.

For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.

Written informed consent according to ICH/GCP and local regulations

Exclusion Criteria

Clinically significant cardiac disease or impaired cardiac function, including any of the following:

Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment

QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes)

Acute myocardial infarction or unstable angina pectoris \< 6 months prior to screening

Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization

Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as \>200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is not necessary unless clinically indicated.

Participant with history of HBV infection will be eligible if on stable anti-viral therapy for \> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening.

Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.

History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible.

Participants 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)

Resolved childhood asthma/atopy

Well-controlled asthma

Type I diabetes mellitus

Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.

Known contraindication to imaging tracer or any product of contrast media and MRI and/or CT contraindications

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 Lake Success?

Yes, this clinical trial (NCT06246149) has an active research site in Lake Success, NY 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.

Uveal Melanoma Treatment Options in Lake Success, NY

If you're searching for uveal melanoma treatment options in Lake Success, NY, this clinical trial (NCT06246149) 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 Lake Success research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced 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 uveal melanoma clinical trials near you to find additional studies recruiting in your area.

Uveal Melanoma Clinical Trial in Lake Success, NY

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