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
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 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
Single group
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
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.
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.
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
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
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
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Brigham and Women's Hospital
Lead sponsor
Dana-Farber Cancer Institute
Sponsor institution
Adenoid Cystic Carcinoma Research Foundation
Collaborator
