Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases
Massachusetts General Hospital
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.
Description
This is a non-randomized, parallel cohort, Phase II study. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The study will be conducted in two independent cohorts. The first cohort (Cohort 1) is comprised of participants with measurable CNS metastases from solid tumors (including patients whose primary cancers are from lung, breast or melanoma) harboring specific alterations, and participants receive the study drug…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1) * Participants must have histologically or cytologically confirmed disease from breast cancer (Cohort 2). * Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm. * Participants must have progressive CNS lesions, as defined by one of the following: * Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eli…
Interventions
- DrugPalbociclib
Administered orally once per day on days 1-21 of 28-day cycles.
- DrugPembrolizumab
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.
Locations (2)
- Massachusetts General HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts