Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

NCT04620187 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20-432
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Salivary Gland Cancer; HER2 Gene Mutation

Keywords

Salivary Gland Cancer; HER2 Gene Mutation

Outcome Measures

Primary Outcomes (1)

• 2 Year Disease-free survival (DFS) Rate

  Kaplan-Meier method will be used to estimate 2 Year Disease-free survival (DFS) Rate

  Time from the date of study registration to first invasive local, regional, distant recurrence, or death due to any cause assessed up to 36 months

Secondary Outcomes (3)

• Adverse Events

  Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months

• Overall survival (OS) Rate

  Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months

• Distant metastatic-free survival (DMFS) Rate

  Time from study registration to the earlier of the first occurrence of distant or metastatic disease, or death due to any cause assessed up to 36 months

Study Arms (1)

Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer

EXPERIMENTAL

Participants will undergo standard of care surgery followed by standard of care radiation and chemotherapy with the addition of T-DM1. Study cycles are 21 days (3 weeks): * Participants will be given the study treatment T-DM1 at a predetermined dose (3.6 mg/kg) intravenously once (1x) every 3 weeks for up to 52 weeks (or about 1 year). * Participants will be given standard of care radiation and chemotherapy * Radiation will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1 * Chemotherapy (cisplatin 40 mg/m2 intravenously or carboplatin AUC 2 intravenously) will be given on Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, and Cycle 3 Day 1 Participants will be followed for 2 years.

Drug: Ado-trastuzumab (T) emtansine (T-DM1); Radiation: Standard of Care Radiotherapy; Drug: Standard of Care Chemotherapy

Interventions

Standard of Care Radiotherapy RADIATION

Radiotherapy to shrink or kill tumors

Also known as: Radiation

Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer

Standard of Care Chemotherapy DRUG

Intravenous injection

Also known as: Cisplatin, carboplatin

Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer

Ado-trastuzumab (T) emtansine (T-DM1) DRUG

Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)

Also known as: Kadcyla

Standard of Care + T-DM1 in HER2-Positive Salivary Gland Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• HER2 positive disease as defined by any of the following:
• 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)
• HER2 or ERBB2 mutated on tumor genomic sequencing assay (see Section 9.1 for permitted HER2 mutations)
• Age 18 years or older
• ECOG performance status ≤ 1 (Karnofsky ≥ 60%, see Appendix A)
• Participant must have normal organ and marrow function as defined below within 14 days prior to study registration:
• leukocytes ≥ 3,000/mcL
• absolute neutrophil count ≥ 1,000/mcL
• hemoglobin ≥ 9.0 g/dL
• platelets ≥ 100,000/mcL
• total bilirubin ≤ 2.0 g/dL
• AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal

You may not qualify if:

• 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.
• Pregnant or lactating women.
• Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Has a known additional malignancy that is progressing or requires active treatment.
• Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.

Sponsors & Collaborators

• Genentech, Inc.: collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (13)

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

RECRUITING

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

RECRUITING

University of Washington Medical Center

Seattle, Washington, 98195, United States

RECRUITING

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

Maytansine; Ado-Trastuzumab Emtansine; Radiation; Cisplatin; Carboplatin

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Physical Phenomena; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Glenn J Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Glenn J Hanna, MD

CONTACT

617-632-3090; glenn_hanna@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 6, 2020
• Study Start: December 24, 2020
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (13)