OncoMatch/Clinical Trials/NCT02896335
Palbociclib and Pembrolizumab In Central Nervous System Metastases
Is NCT02896335 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Palbociclib and Pembrolizumab for metastatic malignant neoplasm to brain.
Treatment: Palbociclib · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Biomarker criteria
Required: CCND1 amplification
Required: CCND2 amplification
Required: CCND3 amplification
Required: CCNE1 amplification
Required: CDK4 amplification
Required: CDK6 amplification
Required: CDKN2A loss
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: CDK4/6 inhibitor
Prior treatment with CDK4/6 inhibitor.
Cannot have received: PD-1 or PD-L1 blocking agent
Prior treatment with PD-1 or PD-L1 blocking agent (Cohort 2)
Lab requirements
Blood counts
leukocytes ≥3,000/mcL; absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; hemoglobin ≥9g/dL
Kidney function
creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 (Cohort 1); creatinine clearance ≥30 mL/min/1.73 m2 (Cohort 2)
Liver function
total bilirubin < 1.5 x ULN OR > 1.5 x ULN allowed if direct bilirubin is within normal range; AST(SGOT)/ALT(SGPT) ≤2.5 × ULN
Cardiac function
baseline QTc <480ms
Participants must have normal organ and marrow function as defined below: ... baseline QTc <480ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Massachusetts General Hospital · Boston, Massachusetts
- Dana Farber Cancer Institute · Boston, Massachusetts
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