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New treatment option for Uveal Melanoma
Official title Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT06070012
What this study is testing
What is Tebentafusp?
Tebentafusp is an investigational medicine, being studied as a potential treatment for uveal melanoma.
Also referred to as Kimmtrak.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase II open-label, single-arm, multi-center study of tebentafusp in HLA- A\ 0201 positive previously untreated (1L) untreated metastatic uveal melanoma (mUM) with an integrated circulating tumor DNA (ctDNA) biomarker.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed untreated metastatic uveal melanoma (mUM). HLA-A\ 0201 genotype positive as assessed using a CLIA-certified...
- If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\ 0201 positive status confirmed prior to...
- If the patient is known to be HLA-A\ 0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI...
- The following HLA testing methodologies are suitable to determine HLA-A\ 0201 positivity:
- Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.
You likely can't join if
- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.
- 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...
- QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.
- NOTE: If the initial automated QTcF interval is \> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at...
- NOTE: Acute myocardial infarction or unstable angina pectoris \< 6 months prior to Screening.
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed untreated metastatic uveal melanoma (mUM). HLA-A\ 0201 genotype positive as assessed using a CLIA-certified blood typing method and confirmed by central review.
- If HLA-A status is not known, blood for HLA-A testing must be submitted during Screening, and HLA-A\ 0201 positive status confirmed prior to enrollment using a CLIA- certified blood typing method.
- If the patient is known to be HLA-A\ 0201 positive, this information must be provided in the Screening packet and centrally reviewed by treating PI and Sponsor-Investigator prior to enrollment.
- The following HLA testing methodologies are suitable to determine HLA-A\ 0201 positivity:
- Multiplex real-time PCR based testing performed by entities including but not limited to Labcorp, and American Red Cross.
- HLA testing as part of peripheral blood molecular profiling technology including but not limited to Caris Life Sciences Molecular Profiling Technology.
- Patients be willing to undergo ctDNA assessment using Signatera assay.
- Have provided newly obtained core biopsy of a tumor lesion not previously irradiated.
- Adequate organ function on screening labs obtained within 4 weeks of Week 1 day 1
- Must meet the following criteria related to prior treatment:
- No prior systemic therapy in the metastatic or advanced setting including chemotherapy, or targeted therapy.
- NOTE: Patients must be tebentafusp naïve.
- NOTE: Patients must not have received prior PD-1, CTLA-4, LAG-3 directed Immune Checkpoint Inhibitor therapy delivered in the adjuvant, and/or neoadjuvant settings unless such therapy was received \>6 months prior...
- No prior regional, liver-directed therapy including chemotherapy, radiotherapy, or embolization.
- Prior surgical resection of oligometastatic disease is allowed.
- Prior neoadjuvant or adjuvant therapy is allowed provided administered in the curative setting in patients with localized disease.
- Life expectancy of \>6 months as estimated by the investigator.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at Screening.
- Patients have measurable disease according to RECIST v.1.1.
- All other relevant medical conditions must be well-managed and stable, in the opinion of the investigator, for at least 28 days prior to first administration of study drug.
What rules you out
- History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies.
- 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...
- QTcF \> 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome.
- NOTE: If the initial automated QTcF interval is \> 470 msec at screening, for the purpose of determining eligibility, the mean QTcF, based on at least 3 ECGs obtained over a brief time interval (ie, within 30 minutes)...
- NOTE: 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 the prior 3 weeks to study Day 1.
- Presence of active brain metastases.
- NOTE: Patients with brain metastases are eligible if all lesions have been treated surgically and/or radiosurgically and there is no evidence of progression for at least 2 weeks by MRI prior to the first dose of study...
- NOTE: Patients with any evidence of leptomeningeal disease are excluded.
- Active infection requiring systemic antibiotic therapy.
- NOTE: Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug.
- Known history of uncontrolled active human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection.
- NOTE: Testing for HIV, HBV and/or HCV is not necessary unless clinically indicated or the patient has a history of HBV/HCV and/or HIV infection.
- NOTE: Patients with curatively treated HBV and/or HCV infection may be enrolled. In these instances, HBV (quantitative HBV DNA) and/or HCV (quantitative HCV RNA) resolution must be documented using a quantitative viral...
- NOTE: Patients with HIV who are stably controlled on highly active antiretroviral therapy (HAART) therapy with a low HIV viral load may be enrolled. In these instances, stable control is defined as HAART compliant with...
- Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following:
- Completely resected carcinoma in situ of any type, resected basal cell and squamous cell carcinomas.
- Malignancies that were treated curatively and have not recurred within 2 years prior to study treatment;
- Any malignancy considered to be indolent that has never required therapy Sponsor-Investigator evaluation.
- Any medical condition that would, in the judgment of the Sponsor-Investigator, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or...
- Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. NOTE: Local steroid therapies (eg, otic...
- History of symptomatic autoimmune disease including:
- Interstitial lung disease.
- Pneumonitis requiring corticosteroid treatment or current pneumonitis.
- Colitis or inflammatory bowel disease. NOTE: However, patients with a history of autoimmune disease who are currently on physiologic hormone repletion (prednisone or equivalent of 10mg or less) and are otherwise...
- 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...
- 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, G-CSF, GM-CSF, M-CSF) ≤ 2 weeks prior to start of study drug. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks prior to...
- 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 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...
- Male patients must be surgically sterile or use double barrier contraception methods from enrollment through treatment and for 6 months following administration of the last dose of study drug.
- Receipt of live or attenuated vaccinations 2 weeks prior to starting study therapy. Patients may receive vaccinations on treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.