Testing Ado-Trastuzumab Emtansine vs. Usual Chemotherapy for HER2-Positive Salivary Gland Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05408845

Provider View

This study is exploring whether a new drug, ado-trastuzumab emtansine, can better shrink tumors in patients with HER2-positive salivary gland cancer that has returned, spread, or cannot be removed by surgery, compared to the usual chemotherapy treatment.

Patient Parameters

Program Overview

This phase II trial is investigating if ado-trastuzumab emtansine can effectively reduce tumors in patients with HER2-positive salivary gland cancer that has come back, spread to other parts of the body, or cannot be surgically removed. Ado-trastuzumab emtansine is a combination of a monoclonal antibody, trastuzumab, and a chemotherapy drug, emtansine. It targets HER2-positive cancer cells and delivers the chemotherapy directly to them. The study aims to see if this treatment works better than the usual chemotherapy with docetaxel and trastuzumab.

Description

The main goal of this study is to see if ado-trastuzumab emtansine (T-DM1) can help patients live longer without their cancer getting worse, compared to the usual treatment of docetaxel plus trastuzumab for HER2-positive salivary gland cancer that has returned or spread.

Secondary goals include comparing how well the cancer responds to each treatment, overall survival rates, and the side effects experienced by patients. The study will also look at patient-reported side effects to understand how tolerable each treatment is.

Exploratory goals involve assessing the response in patients who switch treatments after their cancer progresses and collecting blood and tissue samples for future research on how tumor genetics affect treatment outcomes.

Participants are randomly assigned to one of two groups:

  • Group 1: Receives docetaxel and trastuzumab intravenously every 21 days for up to 6 cycles, unless the cancer progresses or side effects become too severe.
  • Group 2: Receives ado-trastuzumab emtansine intravenously every 21 days, unless the cancer progresses or side effects become too severe.

After completing the study treatment, patients will have follow-up visits every 3 months for 2 years, then every 6 months for 3 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with HER2-positive salivary gland cancer, including subtypes like salivary duct carcinoma and adenocarcinomas.
  • Cancer must be HER2-positive based on specific lab tests.
  • Cancer that cannot be removed by surgery, has returned, or has spread to other parts of the body.
  • Patients with treated brain metastases are eligible if follow-up scans show no progression.
  • Patients with new or growing brain metastases may be eligible if immediate treatment is not needed.
  • Must have measurable or non-measurable disease.
  • Recent medical exams and imaging tests required.
  • Age 18 or older.
  • Adequate heart function and blood cell counts.
  • Normal kidney and liver function.
  • HIV-positive patients on effective treatment with undetectable viral load are eligible.
  • Hepatitis B and C patients must have undetectable viral loads on treatment.
  • Negative pregnancy test for those of childbearing potential.
  • Willing to use effective contraception during and after treatment.
  • Previous or current cancer that does not interfere with this study is allowed.
  • Must provide informed consent.

Exclusion Criteria

  • Previous treatment for this cancer in the advanced stage.
  • Severe heart conditions or recent heart attack.
  • Active infections requiring IV antibiotics.
  • Severe nerve damage or lung disease.
  • Recent severe bleeding events.
  • Allergic reactions to similar drugs.
  • High cumulative doses of certain chemotherapy drugs.
  • Pregnant or breastfeeding individuals.

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