M9241 in Combination With Docetaxel in Adults With Metastatic Castration Sensitive and Castration Resistant Prostate Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

February 23, 2021

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Cancer Of ProstateProstate Neoplasms
Interventions
DRUG

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.

DRUG

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.

DRUG

M7824

M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.

DRUG

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.

DRUG

M9241

M9241 at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH