Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.
Eligibility criteria
Qualifiers
Subject must have histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced salivary gland carcinoma (including any histologic subtype), as defined by 2017 American Joint Committee on Cancer (AJCC), 8th edition.
Willing to provide tissue from a diagnostic biopsy or at the time of cancer resection, and blood samples before, during, and after treatment.
Tumor HER2 expression staining intensity of 2 or 3+ by IHC (from either a preoperative biopsy or resection specimen at the time of oncologic surgery)
HER2 amplification as determined by FISH (HER2/CEP 17 ratio greater than or equal to 2.0 or HER2 mean copy number greater than or equal to 4.0)
Disqualifiers
Patient with AJCC 2017 8th edition stage I or stage IVC (metastatic) disease, or unresectable disease.
Subject who has had prior radiation and/or chemotherapy for head and neck cancer.
Any history of prior HER2 directed therapy.
Active or uncontrolled infection.
Trial design
Treatments tested in this trial
- Ado-trastuzumab (T) emtansine (T-DM1)
- Standard of Care Radiotherapy
- Standard of Care Chemotherapy
Treatment groups
37 Participants
are divided into 1 treatment groupSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Genentech, Inc.
Collaborator
Source ClinicalTrials.gov