Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases

NCT05408871 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: 20000314621R21CA259964-01A1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.

Conditions

Cancer Head Neck; Metastatic Cancer; Metastatic Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Non-invasive quantitative PD-L1 levels will be measured using PET measures (VT) of lesions for the groups of PD-L1 levels (PD-L1 ≥90% vs <1%, PD-L1 ≥50% vs <1%) in head and neck cancer primary lesions

  To test the difference in non-invasive quantitative PD-L1 PET measures (VT) of lesions between different groups of PD-L1 levels (PD-L1 ≥90% vs \<1%) in head and neck cancer primary lesions

  from with in 2 weeks perioperative up to postoperative

Secondary Outcomes (4)

• Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer primary lesion

  from with in 2 weeks perioperative up to postoperative

• Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes

  from with in 2 weeks perioperative up to postoperative

• Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer primary lesion

  from with in 2 weeks perioperative up to postoperative

• Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer locoregional neck metastatic lesions and resected normal lymph nodes

  from with in 2 weeks perioperative up to postoperative

Other Outcomes (1)

• Immunohistochemistry vs PET measure of PD-L1 levels within resected brain metastasis tumor cells

  from with in 2 weeks perioperative up to postoperative

Study Arms (2)

Head and neck cancer

EXPERIMENTAL

Participants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection.

Drug: adnectin 18F-BMS-986192 Head and Neck Cancer

Brain Metastases

EXPERIMENTAL

Participants with metastases to the brain from melanoma, lung cancer, breast cancer.

Drug: adnectin 18F-BMS-986192 Brain Metastases

Interventions

adnectin 18F-BMS-986192 Head and Neck Cancer DRUG

Head and Neck Cancer: PET imaging will be performed after initial diagnosis and within 2 weeks of MRI or CT of the neck done as standard of care. MRI will include T1 weighted pre and post gadolinium spin echo, diffusion weighted imaging, and T2 weighted imaging. CT of the head and neck with contrast will be performed per standard clinical protocol. Patients will get one intravenous line and one radial artery line placed prior to imaging and up to 5.5mCi (204MBq) of \[18F\] PDL192 tracer will be administered intravenously, as a bolus, once the patient is positioned on the scanner. 42 PET data will be acquired at single bed position and in list mode for 120 min after the start of tracer administration. Samples will be drawn from radial artery line.

Also known as: [18F]PDL192

Head and neck cancer

adnectin 18F-BMS-986192 Brain Metastases DRUG

Brain Metastases: Recruited patients will undergo standard clinical MRI within 2 weeks prior to PET, including T1 weighted pre- and post-gadolinium spin-echo and gradient-echo imaging, diffusion weighted imaging, susceptibility weighted imaging (2D SWI), T2 weighted imaging, 3D FLAIR, and combined DCE and dynamic susceptibility contrast (DSC) perfusion (DCE perfusion will be performed first, DSC perfusion will utilize T2 spin echo images). DCE perfusion will be processed on syngo Tissue 4D software (Siemens). DSC perfusion will be processed with syngo MR Perfusion Engine (Siemens). Patients will get one intravenous line and one radial artery line placed prior to imaging and up to 5.5mCi (204MBq) of \[18F\] PDL192 tracer will be administered intravenously, as a bolus, once the patient is positioned on the scanner. 42 PET data will be acquired at single bed position and in list mode for 120 min after the start of tracer administration. Samples will be drawn from radial artery line.

Also known as: [18F]PDL192

Brain Metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable squamous cell carcinoma of the oropharynx (HPV positive and HPV negative).
• Resectability will be confirmed by a surgical co-investigator.
• If available, HPV-association determined by institutional p16 testing (CINtec antibody demonstrating strong and diffuse nuclear and cytoplasmic staining is at least 70% of cells).
• Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter.
• aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal.
• Albumin \> 0 g/dl.
• Creatinine \< 5 x upper limit of normal.
• Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment
• Patients with brain metastases
• Tumor size equal or greater than 1 cm
• Resectability or need for laser interstitial thermal therapy (LITT) will be confirmed by a surgical co-investigator.
• Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter
• AST and ALT \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal.
• Albumin \> 0 g/dl.
• Creatinine \< 5 x upper limit of normal.

You may not qualify if:

• Medical contraindication to surgery.
• Full dose anticoagulation.
• Concomitant invasive malignancy, or malignancy within 2 years except for hormonally responsive breast or prostate cancer, resected non-melanoma skin cancer, resected uterine cervical carcinoma.
• Inability to give informed consent.
• Prior systemic therapy, radiation or gross resection for the tumor under study.
• Women may not be pregnant or breast-feeding.
• Receipt of other systemic therapy including investigational agents, radiation or gross resection for treatment of the tumor under study.
• Medical contraindication to brain surgery.
• Full dose anticoagulation.
• Inability to give informed consent.
• Women may not be pregnant or breast-feeding.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale University PET Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasm Metastasis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mariam S Aboian, MD PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Model Details: Patients with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection (Aim1). Patients with metastases to the brain from melanoma, lung cancer, breast cancer (Aim 2).12 patients with head and neck cancer will be recruited for Aim 1. 12 patients with brain metastases will be recruited for Aim 2.

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 7, 2022
• Study Start: February 21, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 15, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)