TerminatedPhase 1NCT05408871

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

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.

Checked against the public recordLast updated Feb 15, 2024 · Source: ClinicalTrials.gov

StatusTerminated
PhasePhase 1
U.S. locations1
SponsorYale University
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Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 1
Sponsor
Yale University
Interventions being studied
Drug: adnectin 18F-BMS-986192 Head and Neck Cancer; Drug: adnectin 18F-BMS-986192 Brain Metastases
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Biomarkers
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Public criteria

Who may be able to participate

Inclusion Criteria for Head and Neck Cancer: * 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 Inclusion Criteria for Brain Metastases: * 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. * Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment Exclusion Criteria for Head and Neck Cancer: * 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. Exclusion Criteria for Brain Metastases: * Medical contraindication to brain surgery. * Full dose anticoagulation. * Inability to give informed consent. * Women may not be pregnant or breast-feeding.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

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Study sites

U.S. locations

  • Yale University PET CenterNew Haven, Connecticut

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 15, 2024. Always confirm current availability with the study team.

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