REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer

Phase 2 Active not recruiting 26 enrolled Mark Stein Regeneron Pharmaceuticals · collab

NaSingle-groupOpen-labelTreatment

Summary

The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37).

Timeline

Start: 2019-05-16
Primary completion: 2026-11
Completion: 2028-04

Publications

Hawley JE, Obradovic AZ, Dallos MC, Lim EA, Runcie K, Ager CR, McKiernan J, Anderson CB, Decastro GJ, Weintraub J, Virk R, Lowy I, Hu J, Chaimowitz MG, Guo XV, Zhang Y, Haffner MC, Worley J, Stein MN, Califano A, Drake CG. Anti-PD-1 immunotherapy with androgen deprivation therapy induces robust immune infiltration in metastatic castration-sensitive prostate cancer. Cancer Cell. 2023 Nov 13;41(11):1972-1988.e5. doi: 10.1016/j.ccell.2023.10.006. Epub 2023 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cemiplimab	Monoclonal antibody	350 mg	Intravenous
Background	Degarelix	Other / unclassified	240 mg	Subcutaneous
Background	Docetaxel	Small molecule	75 mg/m2	Intravenous
Background	Leuprolide	Other / unclassified	22.5 mg	Subcutaneous

REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer

Summary

Timeline

Publications

Drugs

Indications