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Palbociclib and Pembrolizumab In Central Nervous System Metastases

NCT02896335 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Metastatic Malignant Neoplasm to Brain
  • Recurrent Brain Metastases
  • Progressive Brain Metastases

Interventions

DRUG

Palbociclib

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

DRUG

Pembrolizumab

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.

Sponsors & Collaborators

Principal Investigators

  • Priscilla Brastianos, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2026-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02896335 on ClinicalTrials.gov