Phase II PEMBROLIZUMAB + PALLIATIVE RADIOTHERAPY IN BC

Phase 2 Terminated 8 enrolled Dana-Farber Cancer Institute Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

This research study is studying radiation therapy in combination with an immunotherapy as a possible treatment for metastatic hormone receptor (HR) positive, HER2-negative breast cancer. The interventions involved in this study are: * Palliative Radiotherapy * Pembrolizumab

Timeline

Start: 2017-05-22
Primary completion: 2018-09-04
Completion: 2019-01-11

Outcome

Missed primary endpoint

Stopped: “Based on two-stage design, the study ended at stage 1 with no evidence of promise based on pre-specified decision rule.”

paper RT combined with pembrolizumab did not produce an objective response in patients with heavily pre-treated HR+ MBC. PMID 32113750 ↗

Publications

Results Barroso-Sousa R, Krop IE, Trippa L, Tan-Wasielewski Z, Li T, Osmani W, Andrews C, Dillon D, Richardson ET 3rd, Pastorello RG, Winer EP, Mittendorf EA, Bellon JR, Schoenfeld JD, Tolaney SM. A Phase II Study of Pembrolizumab in Combination With Palliative Radiotherapy for Hormone Receptor-positive Metastatic Breast Cancer. Clin Breast Cancer. 2020 Jun;20(3):238-245. doi: 10.1016/j.clbc.2020.01.012. Epub 2020 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous