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

ConditionsSalivary Gland CancerHER2 Gene Mutation
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Drug

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

  • Standard of Care Radiotherapy

    Radiation

    Radiotherapy to shrink or kill tumors

  • Standard of Care Chemotherapy

    Drug

    Intravenous injection

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: Standard of Care + T-DM1 in HER2-Positive Salivary Gland CancerExperimental treatment 3 interventions

Trial outcomes

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 frame
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

1

Adverse Events

Evaluate adverse events for patient receiving T-DM1, defined as adverse events of all grades utilizing CTCAE v5

Time frame
Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
2

Overall survival (OS) Rate

Overall Survival (OS) estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).

Time frame
Time from study registration to death due to any cause, or censored at date last known alive assessed up to 36 months
3

Distant metastatic-free survival (DMFS) Rate

Distant metastatic-free survival (DMFS) Rate estimated using a Kaplan-Meier or competing risk methodology (whichever is appropriate).

Time frame
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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