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Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer

NCT03072160 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-02-11

Study results available
· View outcomes & findings →

Summary

Background:

Medullary thyroid cancer (MTC) is a tumor of the thyroid gland. Surgery is the only current treatment to cure it. The drug pembrolizumab (MK-3475) is a new type of cancer therapy. It works by allowing the immune system to detect and kill tumor cells.

Objective:

To test how pembrolizumab affects people with MTC and if it can offer them clinical benefit.

Eligibility:

People ages 18 and older with MTC

Patients who have recurrent or metastatic MTC, for whom surgery is not a curative option

Patients with some imaging evidence of MTC

Patients with minimal symptoms related to MTC

Design:

Participants will be screened with:

* Medical history
* Physical exam
* Blood, urine, and heart tests
* Computed tomography (CT) scan or magnetic resonance imaging (MRI): They lie in a machine that takes pictures of the body.
* Bone scan

Participants will be put in a group based on their treatment history:

* Group 1 if they have had an immune stimulating cancer vaccine
* Group 2 if they have had no vaccine

Participants will receive the study drug as a 30-minute intravenous (IV) infusion every 3 weeks. Treatment will continue for up to 2 years as long as they tolerate it and their disease does not get worse.

Participants will have physical exams and blood tests on the day of each infusion. They will have CT and bone scans every 3 months.

Participants may save biopsies before treatment and after starting treatment.

Participants will have a final visit 3-4 weeks after stopping treatment. This will include a physical exam and blood and heart tests.

After this study, participants can join a long-term follow-up study.

Conditions

  • Medullary Thyroid Cancer (MTC)

Interventions

DRUG

Pembrolizumab

Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Ravi A Madan, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-16
Primary Completion
2019-11-22
Completion
2019-11-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03072160 on ClinicalTrials.gov