RecruitingPhase 2NCT02896335

Palbociclib and Pembrolizumab In Central Nervous System Metastases

Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases


Sponsor

Massachusetts General Hospital

Enrollment

45 participants

Start Date

Feb 2, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

This research study is studying This research study is studying the efficacy and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases: * Palbociclib alone (Cohort 1) * The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests two drugs — palbociclib and pembrolizumab — in patients with cancer that has spread to the brain (brain metastases), to see if this combination can slow or stop tumor growth in the brain. **You may be eligible if...** - You have been diagnosed with any solid tumor (such as breast cancer, lung cancer, etc.) that has spread to the brain - There is at least one measurable brain tumor on a scan - Your brain tumors are growing or getting worse - You are in acceptable overall health **You may NOT be eligible if...** - You have no measurable tumors in the brain - Your brain tumors have not progressed (gotten worse) - You have certain infections, serious heart conditions, or severe immune system problems - You are pregnant or breastfeeding Treating brain metastases is very challenging, and this study may help identify new options for patients whose cancer has spread to the brain. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Administered orally once per day on days 1-21 of 28-day cycles.

DRUGPembrolizumab

Pembrolizumab is administered via intravenous (IV) infusion at a dose of 200 mg over 30 minutes once every 21 days. Pembrolizumab cycles are 3 weeks (21 days) long in this study, and participants in Cohort 2 can receive pembrolizumab as long as they are receiving study drug palbociclib.


Locations(2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT02896335


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