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New treatment option for Metastatic Uveal Melanoma
Official title Tebentafusp-tebn With LDT in Metastatic UM
ClinicalTrials.gov ID: NCT06626516
What this study is testing
What is Tebentafusp-Tebn?
Tebentafusp-Tebn is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for metastatic uveal melanoma.
Also referred to as kimmtrak, IMCgp100.
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 study is a multicenter, open label phase I/ II trial to assess the safety and clinical efficacy of tebentafusp-tebn in combination with liver-directed therapies in HLA-A\ 0201 positive patients with metastatic uveal melanoma. In Part 1 of the study, the Prinicipal Investigator will investigate the safety and efficacy of tebentafusp-tebn in combination with hepatic IE in patients with a low to moderate hepatic disease burden.
- 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
- 1\. Age ≥18 years of age 2. Histologically or cytologically confirmed metastatic uveal melanoma in the liver. Patients must have at least one...
- Prior surgery or ablation for oligometastatic disease is allowable.
- Palliative radiation of non-target lesions also allowable. ii. Part 2: Patients may have had prior systemic therapy with chemotherapy, immunotherapy...
- Platelet count ≥ 100,000/mm³
- Hemoglobin \> 8.0g/dL
You likely can't join if
- Parts 1 and 2:
- Failure to meet any of the criteria set forth in the Inclusion criteria section
- History of prior tebentafusp-tebn use
- Prior chemoembolization in Part 2 is not permitted
- History of severe immediate or delayed hypersensitivity reaction to biologic drugs, monoclonal antibodies, iodinated contrast agent
- Presence of symptomatic liver failure including ascites and hepatic encephalopathy
See the full eligibility criteria
- 1\. Age ≥18 years of age 2. Histologically or cytologically confirmed metastatic uveal melanoma in the liver. Patients must have at least one measurable liver metastasis that is ≥ 10 mm in longest diameter by CT scan or...
- Prior surgery or ablation for oligometastatic disease is allowable.
- Palliative radiation of non-target lesions also allowable. ii. Part 2: Patients may have had prior systemic therapy with chemotherapy, immunotherapy, or targeted therapy. They can also have had prior liver directed...
- Platelet count ≥ 100,000/mm³
- Hemoglobin \> 8.0g/dL
- ANC ≥ 1500
- AST and/or ALT \< 3x upper limited of normal (ULN)
- Total bilirubin ≤ 2.0 mg/ml
- Note: Patients with hyperbilirubinemia clinically consistent with an inherited disorder of bilirubin metabolism (e.g., Gilbert syndrome) will be eligible at the discretion of the treating physician and/or the principal...
- PT/PTT \< 1.5x ULN
- Creatinine clearance \> 60mL/min
- Potassium, magnesium, corrected calcium, and phosphate within normal laboratory parameters 10. Women must not be pregnant or breast-feeding. 11. Women of child-bearing potential and men must agree to use adequate...
- Parts 1 and 2:
- Failure to meet any of the criteria set forth in the Inclusion criteria section
- History of prior tebentafusp-tebn use
- Prior chemoembolization in Part 2 is not permitted
- History of severe immediate or delayed hypersensitivity reaction to biologic drugs, monoclonal antibodies, iodinated contrast agent
- Presence of symptomatic liver failure including ascites and hepatic encephalopathy
- Presence of symptomatic or untreated central nervous system (CNS) metastases, or CNS metastases that require corticosteroids within 21 days prior to initiation of study therapy. Patients with brain metastases may be...
- History of another malignancy except for: 1) those who have been disease-free for 3 years prior to study treatment; 2) patients with a history of completely resected non-melanoma skin cancer; 3) patients with indolent...
- 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
- No outstanding toxicities from prior therapies greater than Grade 1. Except for prior immune related side effects such as endocrinopathy that are managed with a stable dose of thyroid or steroid supplement.
- Use of any investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study therapy and during the study.
- Use of hematopoietic colony-stimulating growth factors (eg. G-CSF, GMCSF, M-CSF) within 14 days prior to study treatment initiation. An erythroid-stimulating agent is allowed as long as it was initiated at least 2 weeks...
- Known history of human immunodeficiency virus infection (HIV). Testing for HIV is not necessary unless clinically indicated
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Testing for HBV or HCV status is not necessary unless clinically indicated or if the patient has a history of HBV or HCV infection.
- Patients receiving systemic steroid therapy or any immunosuppressive medication. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable.
- History of bleeding diathesis
- Pregnant, likely to become pregnant, or breastfeeding women
- Uncontrolled concurrent illness, evaluated at investigator discretion
- Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy, or any anatomic abnormalities that would interfere with immunoembolization or chemoembolization:
- Patients with occlusion of the main portal vein
- Inadequate collateral flow around an occluded portal vein as determined by angiography
- Arteriovenous shunt identified on arteriography of the hepatic artery
- Any medical condition that, in the Investigator's judgement, would prevent patient participation in the clinical study due to safety concerns, compliance with study procedures or interpretation of study results
- Part 1 Only:
- History of severe immediate or delayed hypersensitivity reaction to GM-CSF
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, 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 Philadelphia, 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.