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Immuno-pet iMaging resPonses administeRed Immune checkpoiNt inhibiTor — IMPRINT  

NSCLC Clinical Trial

Official title:
Immuno-pet iMaging resPonses administeRed Immune checkpoiNt inhibiTor (IMPRINT)

Clinical Trial Summary

This study investigates whether a single subcutaneous administration of anti-PD-1 antibody can induce CD8+ T-cell tumor-infiltration that can be non-invasively monitored with [89Zr]crefmirlimab berdoxam PET imaging as an imaging biomarker.

Clinical Trial Description

This is a two-armed open-label feasibility study with exploratory endpoints, where subjects are participating for 2 years after completement of enrollment to determine disease-free survival rates. The therapeutic intervention is a single subcutaneous administration of the humanized hinge region-stabilized IgG4 monoclonal anti-PD1 antibody PF-06801591 (sasanlimab) in a fixed dose of 300 mg in a neo-adjuvant setting, with or without radiation therapy, followed by curative-intended surgery. The diagnostic intervention is a radiolabeled imaging tracer [89Zr]Zr-crefmirlimab berdoxam that entails two intravenous administrations of a fixed dose of 1.5 mg protein dose labelled with activity dose 37 MBq Zirconium-89; one at baseline and one at 2 weeks after sasanlimab injection, to visualize CD8+ T-cells in vivo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06218069
Study type Interventional
Source Radboud University Medical Center
Contact Erik HJ Aarntzen, Dr.
Phone +31629669360
Email Erik.Aarntzen@radboudumc.nl
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date August 2024
Completion date March 2027
View Details
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