86
Participants
Start Date
February 23, 2021
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2026
ADT
For mCSPC patients: Androgen Deprivation Therapy (ADT) may include GnRH agonist or monthly degarelix converted to GnRH agonist after 3 months. For mCRPC patients: ADT will be continued as per standard of care.
Prednisone
For mCSPC patients, prednisone is optional and if given, should be taken orally, at 5 mg once a day. For mCRPC patients, prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day as is the patient s preference.
M7824
M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.
Docetaxel
Docetaxel 75mg/m\^2 will be administered intravenously every 21 days (i.e., a 3-week cycle) for up to 6 cycles in mCSPC and until progression or unacceptable toxicity in mCRPC.
M9241
M9241 at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH