Early detection of side effects in patients with metastatic melanoma receiving immune checkpoint inhibitor therapy by investigation of the CD8+ immune infiltrate using [89Zr]Zr-Df-IAB22M2C-PET
- Conditions
- C43Malignant melanoma of skin
- Registration Number
- DRKS00028982
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
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)
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • 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 Outcome Measures
Name Time Method • 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.<br>• 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<br>• Assessment of potential side effects of [89Zr]Df-IAB22M2C up to 24h p.i.