Cancer Head NeckPhase 1NCT05408871
Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
A Phase 1 study testing adnectin 18F-BMS-986192 Head and Neck Cancer and adnectin 18F-BMS-986192 Brain Metastases in people with Cancer Head Neck and Metastatic Cancer, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Head Neck, Metastatic Cancer, Metastatic Lung Cancer
- What is being tested?
- adnectin 18F-BMS-986192 Head and Neck Cancer and adnectin 18F-BMS-986192 Brain Metastases
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 31 Jan 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to treatment
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University PET Center
New Haven, Connecticut, 06519
About this study
Official title: Pilot Study of 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.
Read the detailed description
This study aims to validate a non-invasive quantitative imaging method of whole tumors using a novel PD-L1 positron emission tomography (PET) tracer in patients with head and neck cancer who undergo resection of primary tumor and locoregional lymph node metastases thus providing an excellent model to perform correlative studies with immunohistochemistry (IHC).
The investigators will extend the study to patients with brain metastases because there is a critical need for a non-invasive test for PD-L1 in this population, as biopsy of these lesions is rare.
In this study, the investigators will image patients with brain metastases, which are predominantly from lung cancer and melanoma, that are planned to undergo biopsy. The ultimate goal of this research is to validate quantitative PD-L1 PET imaging in determining PD-L1 expression within primary and metastatic cancer without the need for biopsy and identify parameters of PD-L1 quantitative PET that will allow its translation into clinical practice. This method can then be used to determine which patients may benefit from immunotherapy.
The primary objective of this study aims 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.
Secondary objectives:
- To establish lesion level association between immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions (as the outcome) and PD-L1 PET measures (VT);
- To establish lesion level association between immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT).
- To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in primary head and neck squamous cell carcinoma (SCC) lesions (as the outcome) and PD-L1 PET measures (VT);
- To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT).
Tertiary objective:
To establish lesion level correlation of IHC measures of total/tumor/inflammatory cell PD-L1 levels to PD-L1 (VT) on PET in brain metastases
- Conditions
- Cancer Head Neck, Metastatic Cancer, Metastatic Lung Cancer
- Being tested
- adnectin 18F-BMS-986192 Head and Neck Cancer, adnectin 18F-BMS-986192 Brain Metastases
- Medical subject headings
- Head and Neck Neoplasms, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adnectin 18F-BMS-986192 Head and Neck CancerDrug
Also called [18F]PDL192
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.
adnectin 18F-BMS-986192 Brain MetastasesDrug
Also called [18F]PDL192
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.
| Study group | Role | What they receive |
|---|---|---|
| Head and neck cancer | Experimental | Participants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection. Receives: Drug: adnectin 18F-BMS-986192 Head and Neck Cancer |
| Brain Metastases | Experimental | Participants with metastases to the brain from melanoma, lung cancer, breast cancer. Receives: Drug: adnectin 18F-BMS-986192 Brain Metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.
Measured: 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
To establish lesion level association comparing immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.
Measured: from with in 2 weeks perioperative up to postoperative
Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer primary lesion
To establish lesion level association comparing the degree of tumor inflammatory cell infiltration seen on IHC in primary head and neck SCC lesions (as the outcome) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.
Measured: 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
To establish lesion level association comparing the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT) using Pearson correlation between pathology based measure and imaging based measure.
Measured: from with in 2 weeks perioperative up to postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start21 Feb 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Why it stopped: PI changed institutions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Head NeckStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Julius Chapiro, Yale University
- Investigators
- Mariam S Aboian, MD PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408871
- Sponsor's protocol ID
- 2000031462
- Other IDs
- 1R21CA259964-01A1
- Status last verified
- Feb 2024
- First submitted
- 1 Jun 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases
- ClinicalTrials.gov ID
- NCT05408871
- Acronym / sponsor ID
- 2000031462
- Conditions
- Cancer Head Neck, Metastatic Cancer, Metastatic Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI changed institutions
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aims to validate a non-invasive quantitative imaging method of whole tumors using a novel PD-L1 positron emission tomography (PET) tracer in patients with head and neck cancer who undergo resection of primary tumor and locoregional lymph node metastases thus providing an excellent model to perform correlative studies with immunohistochemistry (IHC).
The investigators will extend the study to patients with brain metastases because there is a critical need for a non-invasive test for PD-L1 in this population, as biopsy of these lesions is rare.
In this study, the investigators will image patients with brain metastases, which are predominantly from lung cancer and melanoma, that are planned to undergo biopsy. The ultimate goal of this research is to validate quantitative PD-L1 PET imaging in determining PD-L1 expression within primary and metastatic cancer without the need for biopsy and identify parameters of PD-L1 quantitative PET that will allow its translation into clinical practice. This method can then be used to determine which patients may benefit from immunotherapy.
The primary objective of this study aims 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.
Secondary objectives:
- To establish lesion level association between immunohistochemistry measures of PD-L1 levels within primary head and neck cancer lesions (as the outcome) and PD-L1 PET measures (VT);
- To establish lesion level association between immunohistochemistry measures of PD-L1 levels within locoregional metastases within the neck and resected normal lymph nodes (as the outcome) and PD-L1 PET measures (VT).
- To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in primary head and neck squamous cell carcinoma (SCC) lesions (as the outcome) and PD-L1 PET measures (VT);
- To establish lesion level association between the degree of tumor inflammatory cell infiltration on IHC in metastatic head and neck SCC lesion (as the outcomes) and PD-L1 PET measures (VT).
Tertiary objective:
To establish lesion level correlation of IHC measures of total/tumor/inflammatory cell PD-L1 levels to PD-L1 (VT) on PET in brain metastases
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Head and neck cancer | Experimental | Drug: adnectin 18F-BMS-986192 Head and Neck CancerParticipants with head and neck squamous cell carcinoma who plan to undergo tumor resection and lymph node resection. |
| Brain Metastases | Experimental | Drug: adnectin 18F-BMS-986192 Brain MetastasesParticipants with metastases to the brain from melanoma, lung cancer, breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adnectin 18F-BMS-986192 Head and Neck CancerAlso: [18F]PDL192Head 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. | Drug | Head and neck cancer |
| adnectin 18F-BMS-986192 Brain MetastasesAlso: [18F]PDL192Brain 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. | Drug | Brain Metastases |
Primary outcome
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
Time frame: from with in 2 weeks perioperative up to postoperative
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
4 secondary outcomes
Immunohistochemistry vs PET measure of PD-L1 levels in head and neck cancer primary lesion
Time frame: 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
Time frame: from with in 2 weeks perioperative up to postoperative
Immunohistochemistry vs PET measure of infiltrating inflammatory cells in head and neck cancer primary lesion
Time frame: 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
Time frame: from with in 2 weeks perioperative up to postoperative
Results and safety
The study was stopped early (reason given: PI changed institutions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariam S Aboian, MD PhD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing adnectin 18F-BMS-986192 Head and Neck Cancer and adnectin 18F-BMS-986192 Brain Metastases in people with Cancer Head Neck and Metastatic Cancer, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI changed institutions). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: from with in 2 weeks perioperative up to postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.