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Tyrosine Kinase Inhibitor
Lenvatinib + Pembrolizumab for Advanced Thyroid Cancer
Phase 2
Recruiting
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
Patients who are unwilling to undergo surgery or external beam radiation
Pathologic findings supporting the clinical impression of anaplastic thyroid carcinoma, including diagnoses consistent with anaplastic thyroid carcinoma, undifferentiated carcinoma, squamous carcinoma, carcinoma with spindled, giant cell, or epithelial features, poorly differentiated carcinoma with pleomorphism, extensive necrosis with tumor cells present
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is studying how well lenvatinib and pembrolizumab work together to treat patients with anaplastic thyroid cancer that cannot be removed by surgery or has spread to other parts of the body.
Who is the study for?
This trial is for adults with advanced anaplastic thyroid cancer that's either spread to nearby areas and can't be surgically removed, or has metastasized. Participants need functioning major organs, no recent surgeries, controlled blood pressure without intense medication, and no severe heart issues. They must not have had chemotherapy within the last week or suffer from unmanaged autoimmune diseases. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The study tests a combination of lenvatinib (which may halt tumor growth by blocking enzymes needed for cell growth) and pembrolizumab (an immunotherapy drug that might help the immune system fight cancer). The goal is to see if this combo works better than each drug alone in treating stage IVB/C anaplastic thyroid cancer.See study design
What are the potential side effects?
Possible side effects include high blood pressure, fatigue, liver problems like increased enzymes, kidney issues reflected by changes in urine protein levels, bleeding risks especially if there's tumor invasion into major vessels, as well as potential allergic reactions to the drugs' components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not willing to have surgery or radiation treatment.
Select...
My thyroid cancer diagnosis includes specific aggressive features.
Select...
My cancer cannot be removed by surgery and has spread.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 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
Progression free survival
Tumor response
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, lenvatinib)Experimental Treatment2 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive lenvatinib PO daily on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Lenvatinib
2005
Completed Phase 4
~2690
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,292 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,618 Total Patients Enrolled
Maria E CabanillasPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe allergic reaction to pembrolizumab or any of the substances it contains.My thyroid cancer diagnosis includes specific aggressive features.I am willing to have tumor biopsies before and after treatment, unless my doctor advises against it.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am not pregnant or breastfeeding.I haven't had chemotherapy in the last week or still have side effects from it.I am not willing to have surgery or radiation treatment.Your liver enzymes (AST and ALT) should not be higher than a certain level. If you have liver metastases, the limit is slightly higher.My blood pressure is high despite taking medication.Your blood creatinine level is not more than 1.5 times the upper limit of normal.My blood thinner medication and INR levels have been stable for the last 28 days.I can care for myself and am up and about more than 50% of my waking hours.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 6 months after treatment.I agree to use birth control and not donate sperm for 8 months after my last treatment dose.You have HIV, active hepatitis B, or active hepatitis C. If you had hepatitis B in the past, you can still join the study, but you need to be watched closely for reactivation. If you had hepatitis C in the past, you can join as long as a specific test shows no active virus in your blood.I haven't had serious coughing up of blood or tumor bleeding in the last two weeks.I have not received any anti-angiogenic treatments.I have had or currently have lung inflammation treated with steroids.Your total bilirubin level should be within a certain range, unless you have Gilbert's syndrome, in which case it can be slightly higher.Your white blood cell count is at least 1.0 x 10^9/L.I have a BRAFV600E mutation and cannot take dabrafenib/trametinib.My urine protein levels are low based on a 24-hour test.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.Your platelet count is at least 100 billion per liter.I have brain metastases that have not been treated.I have not had major surgery within the last week.My cancer cannot be removed by surgery and has spread.I do not have any open wounds or fistulas.I do not have serious heart problems like recent heart attacks or severe heart failure.I have not received a live vaccine in the last 30 days.My electrolyte levels are normal, except possibly for calcium which I am treating.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, lenvatinib)
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.
Pembrolizumab is commonly used for what type of patient?
"Pembrolizumab is an immunotherapy medication that can be used to treat various conditions, such as malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Has the US government given its stamp of approval to Pembrolizumab?
"Pembrolizumab falls into the Phase 2 category, meaning that while there is some evidence of its safety, none exists yet for its efficacy. Our team at Power has given it a score of 2."
Answered by AI
Are patients still being recruited for this experiment?
"Yes, this is an active study that was originally posted on 11/21/2021 according to clinicaltrials.gov."
Answered by AI
What is the research history of Pembrolizumab?
"At the moment, there are 1076 clinical trials underway that are studying Pembrolizumab. Of those active trials, 134 are in Phase 3. Although a large number of the studies for Pembrolizumab originate from Sacramento, California, there are 37371 locations around the world where trials for this treatment are taking place."
Answered by AI
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