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

Recruiting

Conditions: melanoma
10040900

Registration Number: NL-OMON53144

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 22

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

- 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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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