ptake of 89Zr-labeled ipilimumab measured with PET-scan in patients who are treated with ipilimumab

Phase 1

• Conditions: Advanced melanoma; MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-003616-31-NL
• Lead Sponsor: VU medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-18
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

•Advanced/metastatic melanoma
oScheduled for treatment with combination treatment of nivolumab and ipilimumab.
oAge = 18 years.
oHistological or cytological documentation of cancer is required.
oWHO Performance Status of 0 or 1.
oAt least 1 measurable lesion.
oSigned informed consent must be obtained prior to any study procedures.
oPatients must be able to adhere to the study appointments and other protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24

Exclusion Criteria

oPrevious exposure to ipilimumab or nivolumab.
oPregnant 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.
oConcurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug.
oRadiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed.
oMajor surgery within 28 days of start of study drug.
oSubstance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.
oAny condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified