Actively Recruiting
Palbociclib and Pembrolizumab In Central Nervous System Metastases
Led by Massachusetts General Hospital · Updated on 2026-03-12
45
Participants Needed
2
Research Sites
551 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Palbociclib and Pembrolizumab In Central Nervous System Metastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1) or breast cancer (Cohort 2)
- Must have measurable CNS disease with at least one lesion 10 mm or larger
- Must have progressive CNS lesions, including untreated or residual measurable lesions after surgery or radiation
- Age over 18 years
- ECOG performance status of 0, 1, or 2 (Karnofsky >= 60)
- Normal organ and marrow function as defined by specific blood counts and lab values
- Women of child-bearing potential and men must agree to use contraception during and after the study
- Ability to understand and sign informed consent
- Tissue available for genetic sequencing
- Presence of CDK pathway alteration for Cohort 1
- Stable corticosteroid dose for at least 7 days
- Participants with controlled hepatitis B or C infection as specified
You will not qualify if you...
- Prior treatment with CDK4/6 inhibitors
- Chemotherapy, immunotherapy, or radiotherapy within 2 weeks before study entry (6 weeks for certain drugs)
- Receiving other investigational agents
- Receiving other concurrent chemotherapies or immunotherapies except specified hormonal or supportive therapies
- Leptomeningeal involvement of cancer (excluded in Cohort 1)
- Allergic reactions to palbociclib or similar drugs
- Use of drugs that strongly affect CYP3A enzymes
- Uncontrolled illness or infection
- Pregnant or breastfeeding women
- HIV-positive participants on combination antiretroviral therapy (excluded in Cohort 2)
- Use of drugs known to prolong QT interval
- Unable to have MRI scans
- QTc > 480 ms or history of related heart conditions
- Uncontrolled electrolyte disorders
- Active autoimmune disease (Cohort 2)
- History of lung radiation (Cohort 2)
- Prior treatment with PD-1 or PD-L1 blockers (Cohort 2)
- History of allogenic transplant
- History or current pneumonitis/interstitial lung disease requiring steroids
- History of hepatitis B or active hepatitis C infection
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
Research Team
P
Priscilla Brastianos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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