C43
Conditions
Interventions
Group 1: Melanoma patients receiving therapy with the immune checkpoint inhibitors ipilimumab and nivolumab (standard-of-care) will receive PET/CT examinations with the radiotracers [18F]FDG (glucose
Sponsors
Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All patients must meet all the following criteria: • Male or female patients =18 years of age at the time of signing the informed consent • Patients with metastasized or irresectable melanoma stage III/IV • Eastern Cooperative Oncology Group Performance (ECOG) Status = 2 • Patients scheduled for ICT by tumor board decision • Understand and voluntarily sign an informed consent document prior to any study related assessments/ procedures. • Able to adhere to the study visit schedule and other protocol requirements • Consent to practice double-barrier contraception until end of the study (28 days after last [89Zr]Zr-Df-IAB22M2C injection)
Exclusion criteria
Exclusion criteria: Patients will be excluded if one or more of the following criteria are met: • Known hypersensitivity to [89Zr]Zr-Df-IAB22M2C or its components or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. • Clinical signs of active infection (>Grade 2 according to CTCAE version 5.0). • Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery. • Heart failure NYHA III/IV. • Patients not able to declare meaningful informed consent on their own. • Women during pregnancy and lactation; female patients of childbearing potential or male patients with female partners of childbearing potential not willing to practice effective contraception by using a double-barrier method from Day 0 until 28 days post-dose. • Male patients planning to donate sperm while participating in the study and for at least 28 days after end of study treatment. • Participation in other clinical trials or observation period of competing trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Feasibility of the early detection of immune-mediated ICT side effects by semiquantitative assessment of CD8+ lymphocyte infiltration using noninvasive [89Zr]Zr-Df-IAB22M2C PET imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the prediction of immune-mediated ICT side effects by using noninvasive [89Zr]Zr-Df-IAB22M2C PET imaging for semiquantitative assessment of CD8+ lymphocyte infiltration. • To assess the association of the CD8+ lymphocyte infiltration in the tumors, metastasis and lymphoid organs by [89Zr]Zr-Df-IAB22M2C PET with treatment response to ICT according to clinical standard of care [18F]FDG PET/CT until 6 months after start of ICT • Assessment of potential side effects of [89Zr]Df-IAB22M2C up to 24h p.i. | — |
Countries
Germany
Contacts
Public ContactTeresa Amaral
Universität Tübingen, Hautklinik
Outcome results
None listed