Palbociclib and Pembrolizumab In Central Nervous System Metastases

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Palbociclib — DRUG
  Administered orally once per day on days 1-21 of 28-day cycles.
• Pembrolizumab — DRUG
  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.

Study Details

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.

Key Dates

Start date

Feb 2, 2017

Status verified

Mar 2026

Primary completion

Sep 1, 2026

Completion

Sep 1, 2027

Study Design

Enrollment

45 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1 (Palbociclib)
  This arm involves screening for eligibility, study treatment and study visits, and follow up. Cohort 1 participants will receive palbociclib daily at a pre-determined dose for 21 days (Day 1-21) per 28-day cycle. Palbociclib is taken orally. Participants may receive study drug as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing). Participants will be followed for up to 2 years after their treatment with the study drug ends. Up to 30 participants will be enrolled in Cohort 1.
• Experimental: Cohort 2 (Palbociclib in Combination with Pembrolizumab)
  Cohort 2 involves screening for eligibility, study treatment and study visits, and follow up. Participants in Cohort 2 will receive study drugs palbociclib and pembrolizumab. Palbociclib is taken orally once per day for 21 days (Day 1-21) of each 28-day cycle. Pembrolizumab will be administered as an intravenous (IV) infusion once every 21 days. Participants may receive study drugs as long as they do not meet the criteria for ending treatment (no intolerable side effects and disease is not progressing), and will be followed for up to 2 years after they stop study treatment. Up to 15 participants will be enrolled in Cohort 2.

Primary Outcome Measure

Intracranial Clinical Benefit Rate (Cohort 1) [ Time Frame: 8 weeks (Screening through 8 weeks) ]

Central Contacts

• Priscilla Brastianos, MD
  617-724-8770
  [email protected]

Locations (2)

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