Atezolizumab + Chemotherapy for Thyroid Cancer

Overseen by Maria E. Cabanillas, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

Research Team

Maria E. Cabanillas, M.D.

Principal Investigator

M.D. Anderson Cancer Center

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.

Ability to provide informed consent

I have a measurable thyroid cancer lesion, unless I have anaplastic thyroid cancer.

Exclusion Criteria

I do not have eye conditions that exclude me from cohorts 1 and 2.

I do not have a history of serious heart problems, including specific heart rhythm issues.

You have HIV, active hepatitis B, or hepatitis C infections. If you had hepatitis B in the past, you can join the study, but you will need to be watched closely by a specialist. If you have hepatitis C antibodies, you can join only if a specific test is negative.

Treatment Details

Interventions

• Atezolizumab (Monoclonal Antibodies)
• Bevacizumab (Monoclonal Antibodies)
• Cobimetinib (Other)
• Nab-paclitaxel (Other)
• Paclitaxel (Other)
• Vemurafenib (Other)

Trial Overview 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.

Participant Groups

Group I: Cohort IV (nab-paclitaxel, atezolizumab, paclitaxel,) Experimental Treatment 3 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 Treatment 2 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 Treatment 2 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 Treatment 3 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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Dr. Peter WT Pisters

M.D. Anderson Cancer Center

Chief Executive Officer since 2017

MD from University of Western Ontario

Dr. Jeffrey E. Lee

M.D. Anderson Cancer Center

Chief Medical Officer

MD from Stanford University School of Medicine

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School