Trial Summary
What is the purpose of this trial?This trial is testing a combination of atezolizumab and chemotherapy in patients with aggressive thyroid cancer. The treatment aims to boost the immune system and stop cancer cell growth. Atezolizumab helps enhance the immune response against cancer cells.
Eligibility Criteria
This trial is for adults with anaplastic or poorly differentiated thyroid cancer that can't be removed by surgery or has spread. They must have proper kidney and liver function, not be pregnant, agree to use contraception, and have no autoimmune diseases. People who've had certain previous cancer treatments or have serious heart conditions, uncontrolled hypertension, active hepatitis or HIV are excluded.Inclusion Criteria
I can perform all self-care but cannot work.
My thyroid cancer is confirmed to be anaplastic or poorly differentiated.
My cancer cannot be removed by surgery and may have spread.
My cancer has a BRAFV600E mutation and I'm being considered for a specific treatment combination.
Exclusion Criteria
I do not have significant liver disease such as hepatitis or cirrhosis.
I have brain metastases that have not been treated.
I have high blood pressure that is not well-controlled.
Treatment Details
The study tests if atezolizumab combined with chemotherapy (paclitaxel, nab-paclitaxel) and targeted drugs (vemurafenib, cobimetinib) improves outcomes in thyroid cancer compared to standard treatments. It examines how well these drugs work together to stop cancer growth by targeting specific enzymes and boosting the immune system's response.
4Treatment groups
Experimental Treatment
Group I: Cohort IV (nab-paclitaxel, atezolizumab, paclitaxel,)Experimental Treatment3 Interventions
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.
Group II: Cohort III (atezolizumab, bevacizumab)Experimental Treatment2 Interventions
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.
Group III: Cohort II (atezolizumab, cobimetinib)Experimental Treatment2 Interventions
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.
Group IV: Cohort I (vemurafenib, cobimetinib, atezolizumab)Experimental Treatment3 Interventions
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.
Atezolizumab is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
🇪🇺 Approved in European Union as Tecentriq for:
- Melanoma
- Hepatocellular carcinoma
- Small cell lung cancer
- Non-small cell lung cancer
- Urothelial carcinoma
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator