cervical cancer, CSCC, Metastatic solid tumors, microsatellite instable (MSI)-high/deficient mismatch repair (dMMR) cancer, non-small-cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), small cell lung cancer (SCLC) and head and neck squamous cell carcinoma (HNSCC)., these may include but are not limited to melanoma, urothelial cell carcer (UCC)
Conditions
Brief summary
Comparison of standardized uptake values in tumor lesions and tumor-to-blood ratios at different time points and different 89Zr-DFO-REGN3767 antibody dose levels., To evaluate the biodistribution and PK of 89Zr-DFO-REGN3767 antibody by measuring standardized uptake value (SUV) on 89Zr-DFO-REGN3767 PET scans in patients with histologically or cytologically documented locally advanced or metastatic solid tumors who based on available clinical data may benefit from treatment with cemiplimab with or without platinum-based chemotherapy., Safety evaluation through summaries of adverse events, changes in laboratory test results and changes in vital signs after exposure to 89Zr-DFO-REGN3767.
Detailed description
Comparison of tracer uptake, expressed as standardized uptake values, in different tumor lesions within and between patients on 89Zr-PET scans., Correlation of tumor tracer uptake with tumor and immune cell LAG3 expression as assessed by immunohistochemistry on a tumor biopsy sample., Correlation of tumor tracer uptake with response to cemiplimab with or without platinum-based chemotherapy, according to RECIST v1.1., Assessment of change in tumor and normal organ tracer uptake after 2 cycles of cemiplimab with or without chemotherapy
Interventions
DRUGFianlimab
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of standardized uptake values in tumor lesions and tumor-to-blood ratios at different time points and different 89Zr-DFO-REGN3767 antibody dose levels., To evaluate the biodistribution and PK of 89Zr-DFO-REGN3767 antibody by measuring standardized uptake value (SUV) on 89Zr-DFO-REGN3767 PET scans in patients with histologically or cytologically documented locally advanced or metastatic solid tumors who based on available clinical data may benefit from treatment with cemiplimab with or without platinum-based chemotherapy., Safety evaluation through summaries of adverse events, changes in laboratory test results and changes in vital signs after exposure to 89Zr-DFO-REGN3767. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of tracer uptake, expressed as standardized uptake values, in different tumor lesions within and between patients on 89Zr-PET scans., Correlation of tumor tracer uptake with tumor and immune cell LAG3 expression as assessed by immunohistochemistry on a tumor biopsy sample., Correlation of tumor tracer uptake with response to cemiplimab with or without platinum-based chemotherapy, according to RECIST v1.1., Assessment of change in tumor and normal organ tracer uptake after 2 cycles of cemiplimab with or without chemotherapy | — |
Countries
Netherlands
Outcome results
None listed