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New treatment option for Mestastatic Uveal Melanoma
Official title Neoadjuvant Tebentafusp in Patients With Metastatic Uveal Melanoma
ClinicalTrials.gov ID: NCT07057596
What this study is testing
What is Tebentafusp?
Tebentafusp is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for mestastatic uveal melanoma.
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
- Uveal melanoma (UM) is a rare type of melanoma, with an incidence of 4.4 cases per million in Europe each year. During recent years, different treatment approaches have been tested in patients with metastatic UM.
- 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
- Patients must have histologically confirmed metastatic uveal melanoma with Human leukocyte antigen-A\ 0201 positive determined by local assay.
- Patients with histologically proven metastatic uveal melanoma in the liver with reectable or potentially resectable liver metastases evaluated by...
- Minor resection (i.e., less than a hemihepatectomy)
- Major resection (i.e., hemihepatectomy or extended hepatectomy)
- Bilobar resection (including atypical resection).
You likely can't join if
- Presence of extrahepatic disease.
- Patients with concomitant malignancy other than non-melanoma skin cancer, or superficial bladder cancer controlled with local treatment. Patients...
- 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.
See the full eligibility criteria
Who can join
- Patients must have histologically confirmed metastatic uveal melanoma with Human leukocyte antigen-A\ 0201 positive determined by local assay.
- Patients with histologically proven metastatic uveal melanoma in the liver with reectable or potentially resectable liver metastases evaluated by imaging in a multidisciplinary committee. Metastasis can be considered...
- Minor resection (i.e., less than a hemihepatectomy)
- Major resection (i.e., hemihepatectomy or extended hepatectomy)
- Bilobar resection (including atypical resection).
- Must meet the following criteria related to prior treatment:
- No prior systemic therapy in the metastatic or advanced setting including chemotherapy, immunotherapy, or targeted therapy.
- No prior local, liver-directed therapy including chemotherapy, radiotherapy, radiofrequency ablation (RFA), or embolization.
- Prior neoadjuvant or adjuvant therapy is allowed provided it was administered in the curative setting in patients with localized disease.
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written and signed informed consent.
- Male or female patients age ≥ 18 years of age at the time of informed consent.
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-1
- Adequate organ function as defined below (without transfusion):
- Hemoglobin ≥9.0 g/dL.
- Absolute neutrophil count (ANC) \>1.5 x 109/L (\> 1500 per mm3).
- Platelet count ≥ 100 x 109/L (\>75,000 per mm3).
- Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the...
- Both AST and ALT must be \< 5 x ULN.
- Creatinine clearance ⩾50 ml/min calculated by Cockcroft-Gault (Table 4) or another validated method.
- Potassium, magnesium, corrected calcium or phosphate abnormality of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) \> grade 1.
What rules you out
- Presence of extrahepatic disease.
- Patients with concomitant malignancy other than non-melanoma skin cancer, or superficial bladder cancer controlled with local treatment. Patients with prior malignancy must have been disease free for 5 years.
- 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.
- Acute myocardial infarction or unstable angina pectoris \< 6 months prior to Screening.
- History of adrenal insufficiency.
- History of interstitial lung disease
- History of pneumonitis that required corticosteroid treatment or current pneumonitis
- History of colitis or inflammatory bowel disease.
- 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 study drug.
- Known history of human immunodeficiency virus (HIV) infection. Testing for HIV status is not necessary unless clinically indicated or if required by local regulations.
- 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.
- Previous treatment with Tebentafusp.
- Patients receiving systemic steroid therapy or any other immunosuppressive medication at any dose level. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable.
- 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...
- Use of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GMCSF, M-CSF) ≤ 2 weeks prior to the start of study drug. Patients must have completed therapy with hematopoietic colony-stimulating factor at least 2...
- Hypersensitivity to the active substance of tebentafusp or to any of its excipients, including: Citric acid monohydrate (E330) Di-sodium hydrogen phosphate (E339) Mannitol (E421) Trehalose Polysorbate 20 (E432).
- Patients whose circumstances will not permit study completion or adequate follow up.
- 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 child-bearing 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 1 week following administration of the last dose of study drug.
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, State of Berlin, Germany
- L'Hospitalet de Llobregat, Barcelona, Spain
- Madrid, Madrid, Spain
- Valencia, Valencia, Spain
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 Berlin, State of Berlin, Germany; L'Hospitalet de Llobregat, Barcelona, Spain; Madrid, Madrid, Spain; Valencia, Valencia, Spain. 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.