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PD-1 Inhibitor
Pembrolizumab for Thyroid Cancer
Phase 2
Recruiting
Led By Saad A Khan
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Subjects must have received radiation therapy or surgery to primary tumor and have subsequent evidence of ATC/UTC.
Must not have
Prior therapy with certain immunotherapy agents
Known history of Human Immunodeficiency Virus (HIV) infection or Hepatitis B or Hepatitis C virus infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Summary
This trial is testing a new immunotherapy drug to see if it can extend the lives of patients with an aggressive form of thyroid cancer who have no other treatment options.
Who is the study for?
Adults with advanced anaplastic or undifferentiated thyroid cancer, who have no curative treatment options left. Participants must have certain blood cell counts within a healthy range, measurable disease progression, and be in relatively good physical condition (ECOG 0-1). They should not be pregnant and agree to use contraception. Exclusions include recent other cancer treatments, live vaccines, active infections like HIV or hepatitis B/C, autoimmune diseases needing treatment in the last 2 years, severe allergies to pembrolizumab components.
What is being tested?
The trial is testing Pembrolizumab (Keytruda), given intravenously every three weeks at a dose of 200 mg. It continues until the patient's disease progresses further, they can't tolerate it anymore, withdraw consent or pass away. The goal is to see how effective this drug is for treating this type of thyroid cancer.
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems (hepatitis), skin reactions (rash/itching), digestive issues (colitis/diarrhea) and hormone gland problems like thyroid disorders. Other possible side effects are fatigue and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I've had radiation or surgery for my tumor and now have ATC/UTC.
Select...
My cancer can be measured by scans and has grown in previously treated areas.
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My thyroid cancer cannot be removed by surgery or has spread.
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I am 18 years old or older.
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I am 18 years old or older.
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My kidney function tests are within the required range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have previously been treated with specific immunotherapy drugs.
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I have a history of HIV, Hepatitis B, or Hepatitis C.
Select...
I have not had radiotherapy in the last 2 weeks.
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I have received a transplant from a donor.
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I have or had lung inflammation not caused by infection, treated with steroids.
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I am currently being treated for an infection.
Select...
I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Association between safety and toxicity of patients with unresectable or metastatic anaplastic thyroid cancer
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab 200 mgExperimental Treatment1 Intervention
Participants will receive pembrolizumab (Keytruda) 200 mg administered by IV infusion every 3 weeks. Participants will remain on study and receive pembrolizumab for the nominal duration of treatment (35 cycles, approximately 2 years) or until there is evidence of disease progression by RECIST, unacceptable toxicity, withdrawal of consent, or discontinuation of the trial for any other reason.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab (Keytruda)
2020
Completed Phase 1
~10
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,963 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,374 Total Patients Enrolled
Saad A KhanPrincipal InvestigatorStanford University
1 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have previously been treated with specific immunotherapy drugs.I have a history of HIV, Hepatitis B, or Hepatitis C.My thyroid cancer has spread, but it's either been fully removed by surgery or doesn't need neck surgery/radiation.I have not received a live vaccine in the last 30 days.I have not had radiotherapy in the last 2 weeks.I have received a transplant from a donor.I've had radiation or surgery for my tumor and now have ATC/UTC.My hemoglobin level is high enough without needing blood transfusions or medications to increase it.I have or had lung inflammation not caused by infection, treated with steroids.You have a disease that can be measured using specific guidelines.You have a strong allergic reaction to pembrolizumab or any of its ingredients.My cancer can be measured by scans and has grown in previously treated areas.My thyroid cancer cannot be removed by surgery or has spread.I haven't had cancer treatment in the last 4 weeks.I am 18 years old or older.I am currently being treated for an infection.My thyroid cancer is confirmed to be anaplastic or undifferentiated.You have other medical conditions, mental health issues, or problems with drugs or alcohol.I do not have active brain metastases or cancer in the lining of my brain, with some exceptions.I have no other cancers needing treatment in the past year.I have an autoimmune disease but haven't needed systemic treatment in the last 2 years.Your blood and body chemistry need to be within certain ranges.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.Your platelet count is at least 100,000 per microliter within 10 days before starting the treatment with pembrolizumab.Your absolute neutrophil count should be at least 1500 per microliter within 10 days before starting the pembrolizumab treatment.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.My kidney function tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab 200 mg
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.
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