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

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Neoplasms

Clinical Trial Details

NCT number	NCT04605614
Study type	Interventional
Source	City of Hope Medical Center
Contact
Status	Withdrawn
Phase	Phase 1
Start date	August 15, 2022
Completion date	October 30, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT06030427` - Virtual Mindfulness and Weight Management to Mitigate Risk of Relapse and Improve Wellbeing in Cancer Survivors	N/A
Completed	`NCT04337203` - Shared Healthcare Actions and Reflections Electronic Systems in Survivorship	N/A
Recruiting	`NCT05660421` - Itacitinib for the Treatment Steroid Refractory Immune Related Adverse Events Arising From Immune Checkpoint Inhibitors	Phase 2
Suspended	`NCT04060849` - Nozin in Preventing Respiratory Viral Infections in Patients Undergoing Stem Cell Transplant, PREV-NOSE STUDY	Phase 1
Recruiting	`NCT06192875` - A Novel Molecular Approach to Blood DNA Screening for Cancer: Specificity Assessment (The NOMAD Study)
Completed	`NCT04122118` - Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor	N/A
Active, not recruiting	`NCT04940299` - Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma	Phase 2
Active, not recruiting	`NCT03168737` - 18F-Fluoroazomycin Arabinoside PET-CT in Diagnosing Solid Tumors in Patients	Phase 1
Active, not recruiting	`NCT06062901` - An Educational Intervention on Provider Knowledge for the Support of Cancer Survivors	N/A
Active, not recruiting	`NCT02444741` - Pembrolizumab and Stereotactic Body Radiation Therapy or Non-Stereotactic Wide-Field Radiation Therapy in Treating Patients With Non-small Cell Lung Cancer	Phase 1/Phase 2
Terminated	`NCT04081298` - eHealth Diet and Physical Activity Program for the Improvement of Health in Rural Latino Cancer Survivors	N/A
Active, not recruiting	`NCT04555837` - Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer	Phase 1/Phase 2
Completed	`NCT04983901` - PHASE II SINGLE-CENTER, RANDOMIZED, OPEN-LABEL, PROSPECTIVE, STUDY TO DETERMINE THE IMPACT OF SERIAL PROCALCITONIN	Phase 2
Active, not recruiting	`NCT04602026` - The RIOT Trial: Re-Defining Frailty and Improving Outcomes With Prehabilitation for Pancreatic, Liver, or Gastric Cancer	N/A
Recruiting	`NCT04871542` - Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Active, not recruiting	`NCT04592250` - Financial Toxicity in Cancer Patients
Recruiting	`NCT05112614` - Role of Gut Microbiome in Cancer Therapy
Active, not recruiting	`NCT04296305` - Effect of Opioid Infusion Rate on Abuse Liability Potential of Intravenous Hydromorphone for Cancer Pain	Phase 4
Recruiting	`NCT05873608` - Communication Issues in Patient and Provider Discussions of Immunotherapy	N/A
Recruiting	`NCT02464696` - Non-invasive Ventilation in Reducing the Need for Intubation in Patients With Cancer and Respiratory Failure	N/A