Trial intelligence / Profile preview

Palbociclib and Pembrolizumab in Central Nervous System Metastases

NCT02896335Phase 2

Key facts

Status: Recruiting
Start: Feb 2017
Primary completion: Sep 2028
Countries: 1
Sponsor: Massachusetts General Hospital
Modality: Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes, Small Molecules

Drugs: palbociclibpembrolizumab
Conditions: central nervous system metastases

Overview

Phase 2, open-label trial of palbociclib and pembrolizumab in central nervous system metastases (2 cohorts), sponsored by Massachusetts General Hospital. Primary endpoint: Intracranial Clinical Benefit Rate at 8 weeks. Started Feb 2017; status: recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Cohort 1 (Palbociclib)
Palbociclib daily for 21 days per 28-day cycle.
Cohort 2 (Palbociclib + Pembrolizumab)
Palbociclib daily for 21 days per 28-day cycle + Pembrolizumab IV once every 21 days.

Who it enrols

Adults with progressive, measurable CNS metastases from solid tumors (Cohort 1 requires CDK pathway alteration; Cohort 2 requires breast cancer or melanoma). Must have adequate organ function and no prior CDK4/6 or PD-1/PD-L1 inhibitors.

Endpoints

Primary

Intracranial Clinical Benefit Rate8 weeks

Secondary

Extracranial Overall Response Rate8 weeks
Intracranial disease progression rateup to 2 years
Extracranial disease progression rateup to 2 years
Overall Survival Rateup to 2 years
Incidence of Drug Related Toxicities1.5 years

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