Salivary Gland CancerEarly Phase 1NCT05553782
Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
A Early Phase 1 study testing Implantable Microdevice (IMD) in people with Salivary Gland Cancer and Adenoid Cystic Carcinoma of the Salivary Gland, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/ The name of the study intervention involved in this study is: -- implantable microdevice Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Cancer, Adenoid Cystic Carcinoma of the Salivary Gland, Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- Implantable Microdevice (IMD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2023to 1 Aug 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.
- Patients must be deemed medically fit to undergo both percutaneous and surgical procedures by their treating head and neck surgeon and medical oncologist.
- Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.
- Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Participants who are receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Oliver Jonas, Ph.D. contact
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Glenn J Hanna, MD, 617-632-3090, glenn_hanna@dfci.harvard.edu
Glenn J Hanna, MD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Glenn Hanna, MD, 617-632-3090, gjhanna@partners.org
Glenn Hanna, MD
About this study
Official title: Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
This research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/
The name of the study intervention involved in this study is:
-- implantable microdevice
Read the detailed description
This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated head and neck cancer patients undergoing definitive oncologic resection.
- This research study is a Pilot Study, which is the first-time investigators are examining this study device in salivary and head and neck cancers. The placement and removal of the microdevice is being tested for the first time in this type of cancer.
- This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery.
- The microdevice can hold up to 20 drugs alone or in combinations in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers.
It is expected that about 30 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease.
AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.
- Conditions
- Salivary Gland Cancer, Adenoid Cystic Carcinoma of the Salivary Gland, Squamous Cell Carcinoma of Head and Neck, Head and Neck Cancer
- Being tested
- Implantable Microdevice (IMD)
- Keywords
- Salivary Gland Cancer, Adenoid Cystic Carcinoma of the Salivary Gland, Implantable Microdevice IMD, Squamous Cell Carcinoma of Head and Neck
- Medical subject headings
- Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Microdevice (IMD)Combination product
- Percutaneous CT image-guided placement of the microdevice(s). At least one, and up to 3, devices will be placed in each tumor.
- Drugs will be released from the microdevice into local tumor tissues. The duration of drug release will be for a period of 3-5 days while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain.
- Each microdevice harbors up to 20 drugs and/or drug combinations relevant to the treatment of head and neck cancer. The drugs used will include some standard agents approved by the Food and Drug Administration (FDA) for treatment of different types of cancers, or drugs classes under investigational.
- Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine
| Study group | Role | What they receive |
|---|---|---|
| IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM | Experimental | Newly diagnosed, localized head and neck cancers undergoing surgical resection
* Interventional radiology guided IMD placement
* Planned oncologic resection with IMD retrieval 3-5 days after placement
* Standard of care adjuvant treatment
* Tumor specimen analysis for local drug response and molecular analysis Receives: Combination Product: Implantable Microdevice (IMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or Higher Treatment-Related Toxicity Rate
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
Measured: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.
Secondary outcomes (6)
Pharmacodynamic (PD)
Pharmacodynamics reported based on dose/exposure efficacy and safety relationships, there are no clinically significant differences in efficacy and safety between pembrolizumab doses of 200 mg or 2 mg/kg every 3 weeks in patients with melanoma or NSCLC.
Measured: Screening Period 1 day
Evaluate the likelihood of independent drug or combination response/failure in this pilot population to determine the appropriateness of nominating therapies for further clinical investigation
Measured: through study completion, an average of 1 year
Tumor Response
Tumor molecular profiling using a commercially available assay (CARIS® MI Profile) will be performed on pathology material from resection sent for permanent processing using cut unstained tissue slides, in post-operative visit up 14 days
Measured: through study completion, an average of 1 year
Gene Expression Level
Tumor molecular profiling using a commercially available assay (CARIS® MI Profile) will be performed on pathology material from resection sent for permanent processing using cut unstained tissue slides, in post-operative visit up to 14 Days
Measured: through study completion, an average of 1 year
Changes in Tumor Metabolism
Tumor molecular profiling using a commercially available assay (CARIS® MI Profile) will be performed on pathology material from resection sent for permanent processing using cut unstained tissue slides, in post-operative visit up to 14 Days
Measured: through study completion, an average of 1 year
Biomarker levels
For hypothesis-generating biomarker discovery, genome-wide approaches looking at both established and novel candidate biomarkers may be able to identify new biomarkers in head and neck cancer
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Nov 2023
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation
- Responsible party
- Principal investigator, Glenn J. Hanna, M.D., Dana-Farber Cancer Institute
- Investigators
- Glenn J. Hanna, M.D, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553782
- Sponsor's protocol ID
- 22-381
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Drug Screening Using a Novel Implantable Microdevice (IMD) in Head and Neck Cancers: a Window of Opportunity Study
- ClinicalTrials.gov ID
- NCT05553782
- Acronym / sponsor ID
- 22-381
- Conditions
- Salivary Gland Cancer, Adenoid Cystic Carcinoma of the Salivary Gland, Squamous Cell Carcinoma of Head and Neck, Head and Neck Cancer
- Keywords
- Salivary Gland Cancer, Adenoid Cystic Carcinoma of the Salivary Gland, Implantable Microdevice IMD, Squamous Cell Carcinoma of Head and Neck
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Adenoid Cystic Carcinoma Research Foundation
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Aug 2029 (estimated)
- First posted
- 23 Sep 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 research study is studying the effect of different drugs as possible treatments for salivary and other head and neck cancers/
The name of the study intervention involved in this study is:
-- implantable microdevice
Detailed description
This window-of-opportunity pilot study will assess the safety and feasibility of using an implantable microdevice (IMD) to efficiently measure local intratumor response to multiple drugs within previously untreated head and neck cancer patients undergoing definitive oncologic resection.
- This research study is a Pilot Study, which is the first-time investigators are examining this study device in salivary and head and neck cancers. The placement and removal of the microdevice is being tested for the first time in this type of cancer.
- This research study involves drugs that are released by a small implantable microdevice (IMD) as small as the tip of a needle, that is inserted into the tumor and is then removed 3-5 days later during surgery.
- The microdevice can hold up to 20 drugs alone or in combinations in very small concentrations that are able to access the cancer through small pores in the device. When the device is removed along with the cancer at the time of surgery, it will be evaluated to understand which drug(s) may be effective to treat these cancers.
It is expected that about 30 people will take part in this research study.
The U.S. Food and Drug Administration (FDA) has not approved the microdevice a treatment for any disease.
AACRF, a research foundation, is supporting this research study by providing funding for the research study, the study drugs and study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM | Experimental | Combination Product: Implantable Microdevice (IMD)Newly diagnosed, localized head and neck cancers undergoing surgical resection * Interventional radiology guided IMD placement * Planned oncologic resection with IMD retrieval 3-5 days after placement * Standard of care adjuvant treatment * Tumor specimen analysis for local drug response and molecular analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must have histologically confirmed head and neck cancer (salivary or ACC type, or squamous cell carcinoma) without evidence of recurrent, metastatic or advanced, incurable disease undergoing definitive surgical management; any stage disease is permitted (American Joint Committee on Cancer 2017 8th edition).
- Age 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- A measurable primary tumor site both clinically and radiologically measuring at least 1 x 1 cm.
- Participants will undergo laboratory testing within 7 days prior to the microdevice placement: they are required to have a platelet count ≥50,000/mcL, PT/INR <2, and aPTT <1.5x upper limit of normal.
Key exclusion criteria (4 listed)
- Participants who are receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the device placement and the potential risk to the pregnancy of the surgery/device placement.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures. If the patient is on systemic anticoagulation, this should be discussed with the overall PI and treating surgeon
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 |
|---|---|---|
| Implantable Microdevice (IMD)* Percutaneous CT image-guided placement of the microdevice(s). At least one, and up to 3, devices will be placed in each tumor. * Drugs will be released from the microdevice into local tumor tissues. The duration of drug release will be for a period of 3-5 days while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. * Each microdevice harbors up to 20 drugs and/or drug combinations relevant to the treatment of head and neck cancer. The drugs used will include some standard agents approved by the Food and Drug Administration (FDA) for treatment of different types of cancers, or drugs classes under investigational. * Drugs may include all or a subset of the following which each may be tested as single agents or in any number of combinations including, but not limited to: Lenvatinib, Axitinib, All trans retinoic acid (ATRA), Venetoclax, Pembrolizumab, Cisplatin, Carboplatin, Vinorelbine | Combination product | IMD PLACEMENT + SURGICAL RESECTION + ADJUVANT TREATMENT ARM |
Primary outcome
Grade 3 or Higher Treatment-Related Toxicity Rate
Time frame: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.
All grade 3 or higher adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv5 as reported on case report forms were counted. Rate is the proportion of treated participants experiencing at least one treatment-related grade 3 or higher AE of any type during the time of observation.
6 secondary outcomes
Pharmacodynamic (PD)
Time frame: Screening Period 1 day
Evaluate the likelihood of independent drug or combination response/failure in this pilot population to determine the appropriateness of nominating therapies for further clinical investigation
Time frame: through study completion, an average of 1 year
Tumor Response
Time frame: through study completion, an average of 1 year
Gene Expression Level
Time frame: through study completion, an average of 1 year
Changes in Tumor Metabolism
Time frame: through study completion, an average of 1 year
Biomarker levels
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Oliver Jonas, Ph.D. contact
Glenn J. Hanna, M.D principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Implantable Microdevice (IMD) in people with Salivary Gland Cancer and Adenoid Cystic Carcinoma of the Salivary Gland, run by Brigham and Women's Hospital at 2 sites 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenn J. Hanna, M.D. ((617) 632-3090, glenn_hanna@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade 3 or Higher Treatment-Related Toxicity Rate (time frame: AE assessed on post-operative visit, which take placed between 7-14 days after the surgical procedure.). 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 26 Jan 2026.