IPILIMUMAB for Skin cancer | Advanced melanoma

Inclusion criteria

• {"criterion_text":"- Advanced/metastatic melanoma\n- Scheduled for treatment with combination treatment of nivolumab and ipilimumab.\n- Age ≥ 18 years.\n- Histological or cytological documentation of cancer is required.\n- WHO Performance Status of 0 or 1.\n- At least 1 measurable lesion.\n- Signed informed consent must be obtained prior to any study procedures.\n- Patients must be able to adhere to the study appointments and other protocol requirements."}

Exclusion criteria

• {"criterion_text":"- Previous exposure to ipilimumab or nivolumab.\n- 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.\n- Concurrent anticancer chemotherapy, immunotherapy or investigational drug therapy during the study or within 4 weeks after starting the study drug.\n- Radiotherapy of target lesions during study or within 4 weeks after starting the study drug. Palliative radiotherapy will be allowed.\n- Major surgery within 28 days of start of study drug.\n- Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results.\n- Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study."}

Primary endpoints

• {"endpoint_text":"- The detection of 89Zr-ipilimumab in tumor lesions. Tumor lesions will be defined using a diagnostic CT-scan or MRI. The short axis diameter of a measurable tumor lesion is ≥1 cm. The five largest lesions will be used for evaluation.","definition_or_measurement_approach":"Tumor lesions defined by diagnostic CT-scan or MRI; measurable lesion short axis diameter ≥1 cm; the five largest lesions will be used for evaluation; uptake assessed visual (uptake above local background) and quantitative (SUVmean and SUVpeak)."}

Secondary endpoints

• {"endpoint_text":"- Response after starting therapy with ipilimumab/nivolumab combination therapy at 12 and 24 weeks and every 12 weeks thereafter","definition_or_measurement_approach":"Tumor response assessed at 12 and 24 weeks and every 12 weeks thereafter (timing of assessments specified)."}
• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":"Overall survival measured as time to death (no additional definition provided)."}
• {"endpoint_text":"- The detection (visual and quantitative) of 89Zr-ipilimumab in normal tissue","definition_or_measurement_approach":"Detection assessed visually and quantitatively (specific quantitative metrics not further specified here)."}
• {"endpoint_text":"- Adverse events using Common Terminology Criteria Adverse Events, version 4.0 (CTCAE 4.0) & Correlation between side effects of ipilimumab/nivolumab combination therapy and uptake of 89Zr-ipilimumab in normal tissue","definition_or_measurement_approach":"Adverse events graded using CTCAE v4.0; correlation analysis between side effects and 89Zr-ipilimumab uptake in normal tissue."}
• {"endpoint_text":"- CTLA-4+CD4+ expression of PBMCs (before start of ipilimumab and during treatment)","definition_or_measurement_approach":"CTLA-4+CD4+ expression measured on PBMCs at baseline and during treatment (assay specifics not provided)."}
• {"endpoint_text":"- Correlation between CTLA-4+CD4+ expression of PBMCs and uptake of 89Zripilimumab in tissues.","definition_or_measurement_approach":"Correlation analysis between PBMC CTLA-4+CD4+ expression and tissue uptake of 89Zr-ipilimumab (specific statistical methods not provided)."}
• {"endpoint_text":"- Pharmacokinetics & dosimetry of 89Zr-ipilimumab","definition_or_measurement_approach":"Pharmacokinetics and dosimetry assessments of 89Zr-ipilimumab (methods not detailed in record)."}
• {"endpoint_text":"- The SUV in tumor lesions will be compared to the SUV in blood. Specific uptake of ipilimumab in tumor lesions is defined as SUVtumor/SUVblood>1.","definition_or_measurement_approach":"Specific uptake defined as SUVtumor/SUVblood > 1; comparison of SUV in tumor vs blood."}
• {"endpoint_text":"- CTLA-4 expression on tumor infiltrating lymphocytes","definition_or_measurement_approach":"CTLA-4 expression measured on tumor infiltrating lymphocytes (methodology not specified)."}

Netherlands

Earliest CTIS Part Ii Submission Date

04-10-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

4

Number Of Sites

1

Number Of Participants

24

Primary sponsor

Full Name

Stichting Amsterdam UMC

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands