Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is a phase II, open-label, non-randomized, multi-institutional study investigating postoperative or adjuvant human epidermal growth factor receptor (HER2)-directed therapy with adjuvant ado-trastuzumab emtansine (T-DM1) in HER2-positive salivary gland carcinomas (SGC). This research study is: - Studying the use of T-DM1 in combination with radiation and chemotherapy; and the use of maintenance T-DM1 alone for up to a year after surgery - Evaluating the effectiveness, safety, and toxicity of T-DM1 T-DM1 is a specialized antibody targeting HER-2 (a protein that is expressed in some breast and salivary gland cancers). The drug is a HER-2 antibody that is bound to a chemotherapy agent (DM1) and delivered intravenously. T-DM1 then binds cancer cells that express HER-2 and is taken up into the cell to allow DM1 to kill cancer cells in a more targeted way. This allows the use of a targeted treatment along with chemoradiation to treat HER-2 expressing salivary cancers. The U.S. Food and Drug Administration (FDA) has not approved T-DM1 for HER2-positive salivary gland cancer but it has been approved for other uses (for breast cancers that express HER2 protein). The research study procedures include: screening for eligibility and study treatment including evaluations and follow up visits. This research study involves radiation, chemotherapy, and targeted therapy given after surgery for up to 1-year, and participants will be followed for 3 years. It is expected that about 55 people will take part in this research study. Genentech is supporting this research study by providing the research study drug, T-DM1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04620187
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Glenn J Hanna, MD
Phone 617-632-3090
Email glenn_hanna@dfci.harvard.edu
Status Recruiting
Phase Phase 2
Start date December 24, 2020
Completion date February 1, 2026

See also
  Status Clinical Trial Phase
Terminated NCT03729297 - Cabozantinib in Advanced Salivary Gland Cancer Patients Phase 2
Active, not recruiting NCT01969578 - Androgen Deprivation Therapy in Advanced Salivary Gland Cancer Phase 2
Completed NCT01703455 - Activity of Sorafenib in Salivary Gland Cancer Phase 2
Recruiting NCT04140526 - Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC Phase 1/Phase 2
Active, not recruiting NCT05010629 - 9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma Phase 2
Active, not recruiting NCT03781986 - APG-115 in Salivary Gland Cancer Trial Phase 1/Phase 2
Completed NCT03319641 - PSMA-PET Imaging for Advanced ACC/SDC N/A
Recruiting NCT02012699 - Integrated Cancer Repository for Cancer Research
Recruiting NCT04028479 - The Registry of Oncology Outcomes Associated With Testing and Treatment
Recruiting NCT05483374 - The Head and Neck Registry of the European Reference Network on Rare Adult Solid Cancers
Completed NCT04291300 - Lutetium-177-PSMA Radioligand Therapy in Advanced Salivary Gland Cancer Patients Phase 2
Active, not recruiting NCT03172624 - Study of Nivolumab Plus Ipilimumab in Patients With Salivary Gland Cancer Phase 2
Completed NCT00509002 - Iressa Study in Patients With Salivary Gland Cancer Phase 2
Active, not recruiting NCT05008237 - Weekly Docetaxel Plus Cisplatin as First-line Chemotherapy in Metastatic Salivary Gland Cancer Patients : a Multicenter Phase II Study Phase 2
Recruiting NCT03360890 - Pembrolizumab With Chemotherapy for Poorly Chemo-responsive Thyroid and Salivary Gland Tumors Phase 2
Not yet recruiting NCT05898373 - Vedicitumomab Alone or in Combination for the Treatment of Locally Advanced or Metastatic SDC Phase 1/Phase 2
Active, not recruiting NCT02069730 - A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes N/A
Recruiting NCT04209660 - Lenvatinib and Pembrolizumab in People With Advanced Adenoid Cystic Carcinoma and Other Salivary Gland Cancers Phase 2
Completed NCT01344356 - Stereotactic Body Radiotherapy for Head and Neck Tumors Phase 4
Completed NCT03602079 - Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Phase 1/Phase 2