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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

No Placebo-Only Group

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 below

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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.

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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:

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I have previously been treated with specific immunotherapy drugs.

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I have a history of HIV, Hepatitis B, or Hepatitis C.

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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.

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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

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.

Secondary study objectives

Association between safety and toxicity of patients with unresectable or metastatic anaplastic thyroid cancer

Awards & Highlights

No Placebo-Only Group

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

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

0 / 14Eligibility criteria met