What side effects are associated with this type of intervention?

Common treatments for thyroid cancer, particularly those involving immunotherapy with monoclonal antibodies like atezolizumab, can lead to a range of side effects. These include immune-related adverse events (irAEs) such as dermatologic issues (rash, pruritus), gastrointestinal problems (diarrhea), hepatic effects (elevated liver enzymes), and endocrine disturbances (thyroiditis, adrenal insufficiency). Additionally, patients may experience fatigue, infusion reactions, and less commonly, severe inflammatory responses in various organs. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid cancer, including targeted therapies and immunotherapies. For instance, lenvatinib and sorafenib are kinase inhibitors approved for differentiated thyroid cancer, while vandetanib and cabozantinib are approved for medullary thyroid cancer. In terms of immunotherapy, pembrolizumab, a monoclonal antibody targeting PD-1, has shown efficacy in various cancers, including thyroid cancer, by enhancing the immune system's ability to attack tumor cells. These treatments share similarities with atezolizumab, which is being studied for its potential to help the immune system target and inhibit the growth and spread of thyroid cancer cells.

What other types of research exist?

Promising alternatives to Atezolizumab for thyroid cancer patients include Nivolumab and Pembrolizumab, both of which are immune checkpoint inhibitors targeting PD-1. Additionally, combination therapies involving Vemurafenib and Cobimetinib, which target specific enzymes needed for cancer cell growth, may also be considered.

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Monoclonal Antibodies

Atezolizumab + Chemotherapy for Thyroid Cancer

Q: What is the mechanism of action of this treatment?

The most common treatments for thyroid cancer, particularly those similar to atezolizumab, include immunotherapy and chemotherapy. Atezolizumab is an immunotherapy that uses monoclonal antibodies to help the immune system target and destroy cancer cells by inhibiting the PD-L1 pathway, which tumors use to evade immune detection. Other treatments like vemurafenib and cobimetinib inhibit specific enzymes necessary for cancer cell growth, while bevacizumab targets VEGF to prevent tumor blood vessel formation. Chemotherapy agents like nab-paclitaxel and paclitaxel work by disrupting cell division and spreading. These mechanisms are crucial for thyroid cancer patients as they offer targeted approaches to halt cancer progression and improve survival rates.

Phase 2

Waitlist Available

Led By Maria E Cabanillas

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance score (PS) =< 2

Histologically confirmed anaplastic thyroid or poorly differentiated thyroid carcinomas

Must not have

Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease

Untreated brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include allergic reactions to monoclonal antibodies like atezolizumab; nerve damage from paclitaxel; high blood pressure from bevacizumab; joint pain from vemurafenib; rash from cobimetinib; plus common chemo side effects like fatigue, nausea, hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can perform all self-care but cannot work.

Select...

My thyroid cancer is confirmed to be anaplastic or poorly differentiated.

Select...

My cancer cannot be removed by surgery and may have spread.

Select...

My cancer has a BRAFV600E mutation and I'm being considered for a specific treatment combination.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have significant liver disease such as hepatitis or cirrhosis.

Select...

I have brain metastases that have not been treated.

Select...

I have high blood pressure that is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (OS) with targeted therapy + atezolizumab in cohorts 1 and 3 with anaplastic thyroid carcinoma (ATC)

Secondary study objectives

Adverse events of targeted therapy + atezolizumab in cohorts 1-3 with anaplastic thyroid carcinoma (ATC) and poorly differentiated thyroid cancer (PDTC)

Adverse events of taxanes + atezolizumab in cohort 4 with poorly differentiated thyroid cancer (PDTC)

Progression-free survival anaplastic thyroid carcinoma (ATC) and poorly differentiated thyroid cancer (PDTC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nab-paclitaxel

2014

Completed Phase 3

~1950

Bevacizumab

2013

Completed Phase 4

~5540

Cobimetinib

2017

Completed Phase 3

~3300

Paclitaxel

2011

Completed Phase 4

~5370

Vemurafenib

2015

Completed Phase 3

~3550

Atezolizumab

2016

Completed Phase 3

~5860

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for thyroid cancer, particularly those similar to atezolizumab, include immunotherapy and chemotherapy. Atezolizumab is an immunotherapy that uses monoclonal antibodies to help the immune system target and destroy cancer cells by inhibiting the PD-L1 pathway, which tumors use to evade immune detection. Other treatments like vemurafenib and cobimetinib inhibit specific enzymes necessary for cancer cell growth, while bevacizumab targets VEGF to prevent tumor blood vessel formation. Chemotherapy agents like nab-paclitaxel and paclitaxel work by disrupting cell division and spreading. These mechanisms are crucial for thyroid cancer patients as they offer targeted approaches to halt cancer progression and improve survival rates.