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Hepatic radiotherapy added to standard of care for the treatment of HLA A*02:01 positive Metastatic Uveal Melanoma patients
EU CTIS ID: 2024-519760-40-00
What this study is testing
To prolong progression free survival (PFS) with the addition of a liver directed therapy to tebentafusp
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- written informed consent
- Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 8.3, for the course of the study starting with the first dose of study therapy through at least 1 weeks after the last dose of treatment
- Will and ability to comply with the protocol
- Age ≥18 years
- Female and male
- PS (ECOG) 0 or 1
You likely can't join if
- Previous systemic therapy for metastatic uveal melanoma
- Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) or active malignancy requiring intervention
- Hypersensitivity to the active substance or to any of the excipients
- other serious or uncontrolled medical disorder, active infection, physical exam or laboratory findings, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements
- Previous liver directed therapy
- Largest liver metastasis > 8 cm
See the full eligibility criteria
Who can join
- written informed consent
- Female subjects of childbearing potential must be willing to use an adequate method of contraception as outlined in Section 8.3, for the course of the study starting with the first dose of study therapy through at least 1 weeks after the last dose of treatment
- Will and ability to comply with the protocol
- Age ≥18 years
- Female and male
- PS (ECOG) 0 or 1
- Histologically or cytologically confirmed metastatic uveal melanoma HLA-A*02:01 positive
- Presence of liver metastases, at least one measurable lesion (RECIST v 1.1), with largest liver metastasis ≤ 8 cm
- Adequate bone marrow, renal and liver functions: absolute neutrophil count > 1.0 x 109/L; absolute lymphocyte count > 0.5 x 109/L; platelet count > 100 x 109/L;hemoglobin > 8 g/dl;serum creatinine < 1.5 x upper limit of normal (ULN) and/or creatinine clearance > 50 ml/min;total bilirubin < 1.5 x ULN (with the exception of patients with Gilbert Syndrome who will be excluded if total bilirubin > 3.0 x ULN or direct bilirubin > 1.5 x ULN); alanine aminotransferase < 3.0 x ULN; aspartate aminotransferase < 3.0 x ULN
- Woman of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drugs
- Male subjects with female partners of childbearing potential must be willing to use adequate contraception as outlined in Section 8.3 – of the protocol, starting with the first dose of study therapy through at least 1 weeks after the last dose of treatment
What rules you out
- Previous systemic therapy for metastatic uveal melanoma
- Previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) or active malignancy requiring intervention
- Hypersensitivity to the active substance or to any of the excipients
- other serious or uncontrolled medical disorder, active infection, physical exam or laboratory findings, altered mental status, or psychiatric condition that, in the opinion of the investigator, would limit a subject’s ability to comply with the study requirements
- Previous liver directed therapy
- Largest liver metastasis > 8 cm
- Symptomatic central nervous system metastases
- Participants 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 > 160 mmHg or diastolic > 110 mmHg). - History of ventricular arrhythmia currently requiring medical treatment. - Uncontrolled atrial fibrillation. - Electrocardiogram (ECG) QT interval corrected > 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
- Morning cortisol < lower limit of normal (unless the participant has asymptomatic adrenal insufficiency and is receiving stable replacement doses)
- Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn’s disease), within2 years of screening. The following exceptions are permitted: - Vitiligo - Alopecia - Managed hypothyroidism (on stable replacement doses) - Asymptomatic adrenal insufficiency (on stable replacement doses) - Psoriasis - Resolved childhood asthma/atopy - Well-controlled asthma - Type I diabetes mellitus
- Participants 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: - 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.