NCT05728372

64Cu-DOTA Pembrolizumab for Imaging Metastatic Solid Tumors in Patients Receiving Stereotactic Body Radiation

Pilot Trial Using 64Cu-DOTA Pembrolizumab (64CDP) in Patients Receiving Stereotactic Body Radiation Therapy for Oligo-Progressive Solid Tumors

• Status: Withdrawn
• Phase: EARLY_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 clinical trial tests how well using 64Cu-DOTA pembrolizumab (64CDP) with positron emission tomography (PET) scans works to find tumor cells in patients with cancers that have spread from where it first started to other places in the body (metastatic). 64CDP is a compound with pembrolizumab that is joined with a radioactive substance used for diagnostic purpose. Pembrolizumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Targeted drugs such as pembrolizumab may the improve uptake of the radioactive substance in tumor cells. 64CDP may improve ability to evaluate response to treatment in patients with solid tumors.

Detailed description

PRIMARY OBJECTIVES: I. To describe toxicities of 64Cu-DOTA-pembrolizumab (64CDP) positron emission tomography, by evaluation of toxicities including: type, frequency, severity, attribution, time course, and duration. II. To identify changes in 64Cu-DOTA-pembrolizumab (64CDP) uptake in radiated metastatic lesions pre- and post-SBRT. OUTLINE: Patients receive standard of care pembrolizumab intravenously (IV) at baseline. Patients then receive 64CDP IV days 1 and 29 on study. Patients undergo PET scan on days 2 and 30 on study. Patients also undergo standard of care SBRT days 8-18.

Conditions

• Metastatic Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Copper Cu 64-DOTA-pembrolizumab	Given IV
PROCEDURE	Positron Emission Tomography	Undergo PET scan
RADIATION	Stereotactic Body Radiation Therapy	Undergo SBRT

Timeline

• Start date: 2023-08-25
• Primary completion: 2026-11-08
• Completion: 2026-11-08
• First posted: 2023-02-15
• Last updated: 2023-10-10

Regulatory

• FDA-regulated drug study