CD8 PET Imaging in Metastatic Solid Tumours
NCT Number: NCT06534190
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Locally Advanced Solid Tumor
Interventions: RADIATION: 89Zr-Df-crefmirlimab PET scan|DRUG: Nivolumab|DRUG: Cetrelimab|OTHER: zirconium Zr 89 crefmirlimab berdoxam
Sponsor: University Medical Center Groningen
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-11
Locations: VUMC, Amsterdam, 1081 HV, Netherlands|University Medical Center Groningen, Groningen, 9713 GZ, Netherlands|Vall d'Hebron Institute of Oncology (VHIO) / Vall d'Hebron Institute Research (VHIR), Barcelona, 08035, Spain|University of Cambridge, Cambridge, CB2 1TN, United Kingdom

Summary:
This is a multi-center, single-arm trial designed to evaluate the safety and imaging characteristics of 89Zr-Df-crefmirlimab in patients with locally advanced or metastatic solid tumours prior to and during PD-1 antibody therapy.

Primary Outcome Measures: Whole body distribution of 89Zr-Df-crefmirlimab, Evaluate whole body distribution of 89Zr-Df-crefmirlimab in cancer patients prior to and during treatment with an anti-PD-1 antibody by measuring standardized uptake values (SUV) in tumours, healthy tissues and organs., 2 years|Pharmacokinetics (PK) of 89Zr-Df-crefmirlimab, Description of pharmacokinetics (PK) of 89Zr-Df-crefmirlimab by measuring standardized uptake value (SUV) on PET scans performed in patients prior to and during treatment with an anti-PD-1 antibody., 2 years|Tumour tracer uptake with immune cell CD8 expression, Results of immunohistochemical (IHC) scoring of CD8 expression will be described. These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images., 2 years|Changes in tumour volumetry, mpMRI parameters and MRI based texture metrics, DCE-MRI sequences will be evaluated and both semi-quantitative and pharmacokinetic quantitative parameters will be derived using a two-compartmental model., 2 years
Secondary Outcome Measures: Incidence, nature, and severity of adverse events (AE) according to NCI-CTCAE v5.0, Adverse events will be assessed using the NCI-CTCAE v5.0 criteria, categorizing the severity from Grade 1 (mild) to Grade 5 (death)., Up to 100 days after the last study procedure (treatment discontinuation visit)|correlate mpMRI parameters, correlate mpMRI parameters such as Ktrans derived from DCE-MRI; f, D derived from IVIM-DWI and DDKI and K derived from DK-MRI with tumour and immune cell CD8 expression as well as T cell infiltration, 2 years|Treatment response with nivolumab or cetrelimab, correlate response to treatment with nivolumab or cetrelimab, according to the RECIST v1.1 and iRECIST criteria with 89Zr-Df-crefmirlimab uptake in tumour lesions., 2 years
Other Outcome Measures: 89Zr-Df-crefmirlimab uptake with markers of immune infiltrates and other biomarkers for response to ICI therapy, Results of immunohistochemical (IHC) scoring of markers of immune infiltrate other then CD8 expression, such as PDL1, will be described as a semi-quantative score. These IHC results will be compared with imaging tracer standardized uptake value (SUV) in defined volumes of interest (VOIs) of tumor lesions on the PET scan images., 2 years