Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma

Uptake and biodistribution of 89Zirconium-labeled ipilimumab in ipilimumab treated patients with metastatic melanoma - Tumor uptake of 89Zirconium-ipilumumab

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53144

Enrollment

Registered

2015-08-18

Start date

2017-05-11

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Metastasized melanoma or unresectable malignant melanoma - Scheduled for treatment with nivolumab and ipilimumab - Age > 18 years - At least one measurable lesion - WHO performance status 0 or 1

Exclusion criteria

Exclusion criteria: - Previous exposure to ipilimumab - Pregnant or breast feeding women - Concurrent anticancer chemotherapy, immunotherapy or investigational drug during the study or within 4 weeks after starting study drug - Radiotherapy on target lesions during the study or within 4 weeks after starting study drug

Design outcomes

Primary

Measure	Time frame
The primary endpoint is: 1. The detection (visual and quantitative) of 89Zr-ipilimumab in tumor lesions (the short axis diameter of a measurable tumor lesion is >=1 cm. The five largest lesions will be used for evaluation).	—

Secondary

Measure	Time frame
The secondary endpoints are: 1. Clinical outcome (response and survival): - Response after starting therapy with ipilimumab at 12 and 24 weeks and every 12 weeks thereafter - Overall survival 2. The detection (visual and quantitative) of 89Zr-ipilimumab in normal tissue after the first injection of nivolumab/ipilimumab: - visual - quantitative - Visual differences between a regular scanner, with limited field of view, and a long axial field of view PET/CT (total body/Quadra) 3. Side effects: - Adverse events using Common Terminology Criteria Adverse Events, version 4.0 (CTCAE 4.0) - Correlation between side effects of ipilimumab and uptake of 89Zr-ipilimumab in normal tissue 4. Other study parameters: - CTLA-4+CD4+ expression of PBMCs (before start of ipilimumab and during treatment) - Pharmacokinetics of 89Zr-ipilimumab	—

Measure

Time frame

The secondary endpoints are: 1. Clinical outcome (response and survival): - Response after starting therapy with ipilimumab at 12 and 24 weeks and every 12 weeks thereafter - Overall survival 2. The detection (visual and quantitative) of 89Zr-ipilimumab in normal tissue after the first injection of nivolumab/ipilimumab: - visual - quantitative - Visual differences between a regular scanner, with limited field of view, and a long axial field of view PET/CT (total body/Quadra) 3. Side effects: - Adverse events using Common Terminology Criteria Adverse Events, version 4.0 (CTCAE 4.0) - Correlation between side effects of ipilimumab and uptake of 89Zr-ipilimumab in normal tissue 4. Other study parameters: - CTLA-4+CD4+ expression of PBMCs (before start of ipilimumab and during treatment) - Pharmacokinetics of 89Zr-ipilimumab

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Countries

Netherlands

Outcome results