Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Hollandia
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stichting Amsterdam UMC
- Trial code
- EU 2024-516547-11-00
- Record updated
- 2024. október 8.
- Original description
To assess uptake (visual = uptake above local background, and quantitative, expressed as SUVmean and SUVpeak) of 89Zr-ipilimumab in tumor lesions as well as its biodistribution in ipilimumab/nivolumab combination treated patients.Read full original descriptionShow less
To assess uptake (visual = uptake above local background, and quantitative, expressed as SUVmean and SUVpeak) of 89Zr-ipilimumab in tumor lesions as well as its biodistribution in ipilimumab/nivolumab combination treated patients.
Inclusion: Advanced/metastatic melanoma; Scheduled for treatment with combination treatment of nivolumab and ipilimumab; Age ≥ 18 years; Histological or cytological documentation of cancer is required; WHO Performance Status of 0 or 1; At least 1 measurable lesion; Signed informed consent must be obtained prior to any study procedures; Patients must be able to adhere to the study appointments and other protocol requirements.
Exclusion: Previous exposure to ipilimumab or nivolumab; Pregnant or breast-feeding subjects. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g. cervical cap, condom and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug; Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug; Radiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed; Major surgery within 28 days of start of study drug; Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results; Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.