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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Cancer Institute (NCI)

Criteria

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.