65
Participants
Start Date
June 12, 2023
Primary Completion Date
August 1, 2026
Study Completion Date
December 1, 2026
M9241
In the safety lead in, M9241 will be given in de-escalating doses (starting dose 16.8 mcg/kg, and de-escalated if needed to 12 mcg/kg, or 8 mcg/kg) every 4 weeks for 3 doses. Within 4 weeks after completing SBRT, those participants receiving immunotherapy agents will receive M9241 by subcutaneous injection at dose determined during the safety lead in every 4 weeks for 3 doses.
Stereotactic Body Radiation Therapy (SBRT)
SBRT to the prostate will be delivered in 5 fractions of radiation each of 7.25-8.0 Gy, every other day over the course of 10 business days (2-3 weeks). The total dose will be 36.25-40 Gy
RECRUITING
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH