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NCT03072160 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT03072160: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT03072160 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03072160, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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.
Primary Outcome
Participants with medullary thyroid cancer were administered a programmed cell death protein 1 (PD1) inhibitor to determine if any experienced a 50% or greater decline in calcitonin levels. A calcitonin response is defined as participants with a ≥50% decline from baseline that is then confirmed on a subsequent calcitonin assessment at least one week later.
Interventions
- DRUG Pembrolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-06-16 |
| Est. Completion | 2019-11-22 |
| Phase | Phase 2 |
What the finished NCT03072160 record still lists
NCT03072160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Pembrolizumab is the first listed.
NCT03072160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03072160 about?
NCT03072160 is a clinical study titled "Pembrolizumab in Recurrent or Metastatic Medullary Thyroid Cancer". 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 pembrolizum...
What is the current status of trial NCT03072160?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2017-06-16. Estimated completion is 2019-11-22.
What interventions are being tested in trial NCT03072160?
The interventions under investigation include: Pembrolizumab (DRUG).
Who is sponsoring clinical trial NCT03072160?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03072160's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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