NCT04605614

64Cu-DOTA-pembrolizumab PET for the Study of PD1 Expression

A Phase I Study of 64Cu Pembrolizumab PET Imaging for In Vivo Expression of PD1

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial evaluates the best dose and side effects of copper (64Cu)-DOTA-pembrolizumab positron emission tomography (PET) for the study of PD1 expression. 64Cu is a radiotracer that binds to a molecule, PD1, that is found on immune cells that are found in the tumor. PD1 is short for 'programmed cell death protein 1'. When 64Cu-DOTA-pembrolizumab is injected into the patient's bloodstream, the 64Cu-pembrolizumab travels throughout the body and sticks to any tumor that has PD1 positive immune cells. Identifying the expression of PD1 in the tumor may help assess whether patients will respond to immunotherapy, and may detect clusters of immune cells when they are still too small to be detected by other Food and Drug Administration (FDA) approved techniques.

Detailed description

PRIMARY OBJECTIVE: I. To assess safety and tolerability of unlabeled pembrolizumab followed by 64Cu-tetraxetan (DOTA)-pembrolizumab positron emission tomography, at each dose level, by evaluation of toxicities including: type, frequency, severity, attribution, time course and duration. SECONDARY OBJECTIVES: I. Generate initial estimates of the biodistribution of the 64Cu-DOTA-pembrolizumab and the preferred dose of cold antibody. II. Determine the dose of pre-administered unlabeled pembrolizumab that improves image quality by qualitative assessment by the radiologist of 64Cu-DOTA-pembrolizumab. III. Evaluate the performance of 64Cu-DOTA-pembrolizumab in detecting tumor lesions. OUTLINE: This is a dose-escalation study of 64Cu-DOTA-pembrolizumab. Patients receive pembrolizumab intravenously (IV) over 30 minutes, and within 6 hours also receive 64Cu-DOTA-pembrolizumab via slow IV push over \> 1 minute on day 0. Patients then undergo PET over 60 minutes on day 1. After completion of study treatment, patients are followed up for 3 days.

Conditions

• Hematopoietic and Lymphoid Cell Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
RADIATION	Copper Cu 64-DOTA-pembrolizumab	Given IV
BIOLOGICAL	Pembrolizumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET

Timeline

• Start date: 2022-08-15
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2020-10-28
• Last updated: 2022-06-09

Regulatory

• FDA-regulated drug study