Status:
UNKNOWN
Uptake and Biodistribution of 89Zirconium-labeled Ipilimumab in Ipilimumab Treated Patients With Metastatic Melanoma
Lead Sponsor:
Amsterdam UMC, location VUmc
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Rationale: Ipilimumab, a monoclonal antibody targeting CTLA-4, is approved for the treatment of metastatic melanoma and significantly increases median overall survival. However, use of this drug is a...
Detailed Description
see above
Eligibility Criteria
Inclusion
- Advanced/metastatic melanoma.
- Scheduled for treatment with 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.
- 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.
Key Trial Info
Start Date :
February 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 15 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03313323
Start Date
February 16 2017
End Date
February 15 2022
Last Update
April 15 2021
Active Locations (1)
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1
VU Medical Center
Amsterdam, North Holland, Netherlands, 1181HV