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Monoclonal Antibodies
Atezolizumab + Chemotherapy for Thyroid Cancer
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying how well atezolizumab & chemotherapy works in treating patients with anaplastic or poorly differentiated thyroid cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall survival (OS) with targeted therapy + atezolizumab in cohorts 1 and 3 with anaplastic thyroid carcinoma (ATC)
Secondary outcome measures
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)
Efficacy determined per RECIST of taxanes + atezolizumab in cohort 4 with poorly differentiated thyroid cancer (PDTC)
+3 moreTrial 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
Cobimetinib
2017
Completed Phase 3
~2660
Bevacizumab
2013
Completed Phase 4
~5280
Nab-paclitaxel
2014
Completed Phase 3
~2030
Paclitaxel
2011
Completed Phase 4
~5380
Vemurafenib
2015
Completed Phase 3
~3100
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,321 Total Patients Enrolled
Maria E CabanillasPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can perform all self-care but cannot work.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.I am not pregnant or breastfeeding, and if I can have children, I'm using birth control.I haven't taken corticosteroids in the last 10 days, except for necessary replacement therapy.I have not had significant coughing up of blood or tumor bleeding in the last two weeks.I have a measurable thyroid cancer lesion, unless I have anaplastic thyroid cancer.Your liver enzymes (AST and ALT) are not more than 2.5 times the upper limit of normal. If you have liver tumors, they should not be more than 5 times the upper limit of normal.Your blood creatinine level is within a certain range.Your white blood cell count is at least 1.0 x 10^9 per liter.I have been treated with specific immune therapy but not anti-CTLA-4, or I meet the requirements for anti-CTLA-4 treatment.I do not have significant liver disease such as hepatitis or cirrhosis.I have brain metastases that have not been treated.I haven't had chemotherapy in the last 21 days, except for paclitaxel or nab-paclitaxel.I have high blood pressure that is not well-controlled.I have not had a heart attack or severe heart issues in the last 3 months and my heart's pumping ability is within normal range.My thyroid cancer is confirmed to be anaplastic or poorly differentiated.My cancer cannot be removed by surgery and may have spread.I am not willing to have surgery or external radiation.My blood thinner medication and INR levels have been stable for the last 28 days.My cancer has a BRAFV600E mutation and I'm being considered for a specific treatment combination.I am willing to have tumor biopsies before and after atezolizumab treatment, if my doctor agrees it's safe.I am using effective birth control and have a negative pregnancy test if applicable.If you're not taking anticoagulant medication, your blood clotting time should not be too high within 28 days before starting the study treatment.Your platelet count is at least 100 billion per liter.You have a known autoimmune disease that is currently active or suspected.Your total bilirubin level is within a certain range, and it's higher for people with Gilbert's syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort IV (nab-paclitaxel, atezolizumab, paclitaxel,)
- Group 2: Cohort II (atezolizumab, cobimetinib)
- Group 3: Cohort III (atezolizumab, bevacizumab)
- Group 4: Cohort I (vemurafenib, cobimetinib, atezolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential health risks are associated with Atezolizumab use?
"Our safety assessment of Atezolizumab yielded a score of 2, taking into account the Phase 2 status of the drug which implies limited data demonstrating its safety but no evidence for efficacy."
Answered by AI
Under what circumstances does Atezolizumab typically get administered?
"Atezolizumab has proven to be an effective solution for medical professionals seeking treatment options for recurrent cervical cancer, locally advanced non-small cell lung cancer, and metastatic bladder cancer."
Answered by AI
How many participants are involved in this research endeavor?
"Affirmative. In accordance with the information present on clinicaltrials.gov, this medical trial is currently recruiting individuals. This particular investigation was launched on July 27th 2017 and has been modified most recently in October 31st 2022. 50 patients have to be enrolled from a single site for participation."
Answered by AI
Have any other experiments been conducted with Atezolizumab?
"Currently, 1425 studies concerning Atezolizumab are underway with 340 at the Phase 3 stage. Shanghai is a hub for Atezolizumab research but there are 70,082 sites running trials related to this medication across the globe."
Answered by AI
Is the trial currently searching for new participants?
"Affirmative. Clinicaltrials.gov has information showing that this experiment is actively recruiting, first posted on July 27th 2017 and last updated October 31st 2022. The research team requires 50 participants from a single medical facility for the trial's completion."
Answered by AI
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