Phase II Study of Radiation and Pembrolizumab for Anaplastic Thyroid Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05059470

Provider View

This clinical trial is testing whether adding the drug pembrolizumab after radiation therapy can help control anaplastic thyroid cancer that is localized to the neck. The study aims to find out how long patients can live without the cancer getting worse and to assess overall survival rates.

Patient Parameters

Program Overview

This study is exploring the use of pembrolizumab, a type of immunotherapy, after radiation treatment in patients with stage IVB anaplastic thyroid cancer (ATC) that is confined to the neck. The goal is to see if this combination can help patients live longer without the cancer progressing or spreading. Patients will be divided into groups based on the dose of radiation they receive before starting pembrolizumab.

Description

The main goal of this study is to determine how long patients with stage IVB anaplastic thyroid cancer can live without their cancer getting worse after receiving radiation therapy followed by pembrolizumab. The study will also look at overall survival rates and how long patients remain free of cancer after treatment.

Patients will be divided into groups based on the amount of radiation they receive. The study will also explore the effects of surgery and chemotherapy in combination with pembrolizumab.

Participants must have completed radiation therapy, with or without chemotherapy, before starting pembrolizumab. The treatment with pembrolizumab will begin 2 to 6 weeks after radiation, once any side effects from radiation and chemotherapy are manageable.

The study will include both men and women who meet specific health criteria and agree to use contraception during and after the study to prevent pregnancy. Participants must provide informed consent and have a good performance status, meaning they are able to carry out daily activities with little or no assistance.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a diagnosis of anaplastic thyroid cancer.
  • Cancer must be stage IVB, meaning it is localized to the neck and cannot be surgically removed, or has been completely removed with no spread outside the neck.
  • Must have completed radiation therapy, with or without chemotherapy, before starting pembrolizumab.
  • Women must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
  • Men must agree to use contraception and not donate sperm during and after the study.
  • Must provide written informed consent to participate.
  • Must have a good performance status, able to perform daily activities.
  • Must have adequate organ function as determined by specific medical tests.

Exclusion Criteria

  • Women who are pregnant or have a positive pregnancy test before starting pembrolizumab.
  • Previous treatment with pembrolizumab or similar drugs.
  • Recent vaccination with live vaccines.
  • Participation in another clinical trial within 4 weeks before starting this study.
  • Immunodeficiency or use of high-dose steroids or other immunosuppressive drugs.
  • Severe allergy to pembrolizumab or its ingredients.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • History of lung disease requiring steroids or current lung disease not related to radiation.
  • Active infection requiring treatment.
  • Known HIV or active hepatitis B or C infection.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.