Study on Atezolizumab with Chemotherapy for Treating Anaplastic or Poorly Differentiated Thyroid Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03181100

Provider View

This clinical trial is exploring whether a combination of the immunotherapy drug atezolizumab and chemotherapy can better treat patients with anaplastic or poorly differentiated thyroid cancer compared to standard treatments.

Patient Parameters

Program Overview

The purpose of this study is to see if combining the immunotherapy drug atezolizumab with chemotherapy can help the body's immune system attack thyroid cancer more effectively. Atezolizumab is a type of immunotherapy that may help the immune system target cancer cells. The study also includes other drugs like vemurafenib, cobimetinib, bevacizumab, nab-paclitaxel, and paclitaxel, which work in different ways to stop cancer cells from growing and spreading. Researchers want to find out if this combination works better than current treatments for patients with anaplastic or poorly differentiated thyroid cancer.

Description

The main goal of this study is to determine if the combination of targeted therapy and atezolizumab can improve the overall survival of patients with anaplastic thyroid cancer (ATC). The study also aims to evaluate the safety and effectiveness of this combination in patients with poorly differentiated thyroid cancer (PDTC). Researchers will look at how well the treatment works in shrinking tumors and preventing cancer from getting worse.

Patients will be divided into four groups based on specific genetic mutations in their cancer:

  • Cohort I (BRAF Mutation): Patients will take vemurafenib and cobimetinib pills and receive atezolizumab through an IV. Treatment cycles repeat every 28 days.
  • Cohort II (RAS, NF1, or NF2 Mutation): Patients will take cobimetinib pills and receive atezolizumab through an IV. Treatment cycles repeat every 28 days.
  • Cohort III (Non-BRAF/Non-RAS Mutation): Patients will receive atezolizumab and bevacizumab through an IV. Treatment cycles repeat every 21 days.
  • Cohort IV: Patients will receive nab-paclitaxel and atezolizumab through an IV. Paclitaxel may be used as a substitute for nab-paclitaxel. Treatment cycles repeat every 21 days.

After completing the study treatment, patients will have follow-up visits every 3 months for the first 2 years, every 6 months for the next 2 years, and then once a year.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with anaplastic or poorly differentiated thyroid cancer.
  • Cancer cannot be removed by surgery or has spread to other parts of the body.
  • Patients with poorly differentiated thyroid cancer must have at least one measurable tumor.
  • Blood tests showing normal liver and kidney function.
  • Adequate blood cell counts.
  • Willing to undergo tumor biopsy before and after treatment.
  • ECOG performance status of 0 to 2, indicating good overall health.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception during the study.
  • Ability to provide informed consent.
  • Additional criteria for patients with BRAF mutation in Cohort 1, including specific blood test results.

Exclusion Criteria

  • Active autoimmune diseases, except for certain stable conditions.
  • Recent use of certain blood thinners or previous treatment with specific immunotherapy drugs.
  • Significant liver disease or infections like HIV or hepatitis.
  • Pregnant or breastfeeding women.
  • Untreated brain metastases.
  • Recent chemotherapy, except for specific drugs allowed in the study.
  • Use of corticosteroids within 10 days before starting atezolizumab, except for certain conditions.
  • Uncontrolled high blood pressure.
  • Additional criteria for specific cohorts, such as eye conditions or heart problems.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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