Study on Pembrolizumab and Chemotherapy for Thyroid and Salivary Gland Tumors That Don't Respond Well to Treatment

Sponsor: University of Chicago

Sponsor score: 0

ClinicalTrials ID:NCT03360890

Provider View

This clinical trial is testing a combination of the immunotherapy drug pembrolizumab and the chemotherapy drug docetaxel to see if they can help treat thyroid and salivary gland tumors that have not responded well to standard treatments.

Patient Parameters

Program Overview

This study is exploring whether a combination of pembrolizumab, an immunotherapy drug, and docetaxel, a chemotherapy drug, can effectively treat thyroid and salivary gland tumors that have not responded to standard treatments. Participants will receive these medications every three weeks for several cycles, followed by maintenance therapy with pembrolizumab alone.

Description

Eligible patients will be divided into two groups based on their type of cancer:

  • Group 1: Patients with salivary gland tumors that have no standard treatment options.
  • Group 2: Patients with aggressive thyroid cancer that have no standard treatment options.

Both groups will undergo a biopsy and start treatment with pembrolizumab and docetaxel every three weeks for 3 to 6 cycles. If the tumor is accessible, a biopsy will be done after three weeks of treatment.

After completing the initial cycles, patients will continue with pembrolizumab alone every three weeks until the cancer progresses or for up to 35 cycles (about 2 years).

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of cancer that cannot be surgically removed or cured with standard treatments:
    • Group A: Salivary gland cancers like mucoepidermoid carcinoma or adenocarcinoma.
    • Group B: Thyroid cancer that does not respond to radioactive iodine and other treatments.
  • Must be in good general health with an ECOG performance status of 0 or 1.
  • Must agree to a biopsy if the tumor is accessible and safe to biopsy.
  • Must have measurable disease according to specific criteria.
  • Must have a life expectancy of more than 12 weeks.
  • Must provide tissue samples for PD-L1 testing.
  • Must be 18 years or older.
  • Must have adequate organ function as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use two methods of birth control or abstain from sex during the study and for 120 days after the last dose.
  • Men must agree to use contraception during the study and for 120 days after the last dose.

Exclusion Criteria

  • Currently participating in another study or have recently received investigational treatment.
  • Have an immune deficiency or are taking high doses of steroids or other immune-suppressing drugs.
  • Have a history of active tuberculosis.
  • Are allergic to pembrolizumab, docetaxel, or their ingredients.
  • Have received certain cancer treatments recently and have not recovered from side effects.
  • Have another progressing cancer that requires treatment.
  • Have active brain metastases or cancer in the brain lining.
  • Have an active autoimmune disease requiring treatment in the past two years.
  • Have a history of non-infectious lung inflammation.
  • Have any condition that could interfere with the study or pose a risk to the patient.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Are pregnant or breastfeeding, or planning to conceive during the study.
  • Have a history of HIV, unless well-controlled.
  • Have active hepatitis B or C.
  • Have received a live vaccine recently.
  • Have had an organ transplant requiring immune-suppressing drugs.
  • Have significant heart disease or recent heart attack.

Locations

FACILITYZIPCITYSTATE
University of Chicago Comprehensive Cancer Center60637ChicagoIllinois

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