Atezolizumab With Chemotherapy in Treating Patients With Anaplastic or Poorly Differentiated Thyroid Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03181100
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Thyroid Gland Carcinoma
  • Poorly Differentiated Thyroid Gland Carcinoma
  • Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8
  • Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8
  • Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8
  • Thyroid Gland Anaplastic Carcinoma
  • Unresectable Thyroid Gland Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Bevacizumab — BIOLOGICAL
    Given IV
  • Cobimetinib — DRUG
    Given PO
  • Nab-paclitaxel — DRUG
    Given IV
  • Paclitaxel — DRUG
    Given IV
  • Vemurafenib — DRUG
    Given PO

Study Details

This phase II trial studies how well atezolizumab in combination with chemotherapy works in treating patients with anaplastic or poorly differentiated thyroid cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Vemurafenib and cobimetinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of cancer cells to grow and spread. Drugs such as nab-paclitaxel and paclitaxel work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial is being done to see if atezolizumab in combination with chemotherapy works better in treating patients with anaplastic or poorly differentiated thyroid cancer compared to standard treatments.

Key Dates

Start date
Jul 27, 2017
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort I (vemurafenib, cobimetinib, atezolizumab)
    Patients receive vemurafenib PO BID on days 1-21, cobimetinib PO QD on days 1-21, and atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity.
  • Experimental: Cohort II (atezolizumab, cobimetinib)
    Patients receive cobimetinib PO QD on days 1-21 and atezolizumab IV over 30-60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression and unacceptable toxicity.
  • Experimental: Cohort III (atezolizumab, bevacizumab)
    Patients receive atezolizumab IV over 30-60 minutes and bevacizumab IV over 60-90 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression and unacceptable toxicity.
  • Experimental: Cohort IV (nab-paclitaxel, atezolizumab, paclitaxel,)
    Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 and atezolizumab IV on day 1 over 30-60 minutes. Patients may receive paclitaxel IV over 30 minutes on day 1 as a substitute for nab-paclitaxel. Cycles repeat every 21 days in the absence of disease progression and unacceptable toxicity.

Primary Outcome Measure

Overall survival (OS) with targeted therapy + atezolizumab in cohorts 1 and 3 with anaplastic thyroid carcinoma (ATC) [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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