NCT04235777View on ClinicalTrials.gov

Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies

PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

July 13, 2020

Primary Completion Date

December 1, 2027

Study Completion Date

December 1, 2027

Conditions
Urothelial CancerBladder CancerGenitourinary CancerUrogenital NeoplasmsUrogenital Cancer
Interventions
RADIATION

Stereotactic body radiation therapy (SBRT)

A fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and PDS01ADC

DRUG

PDS01ADC

An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT

DRUG

M7824

1200 mg administered IV every two weeks while on PDS01ADC and with or without SBRT

Trial Locations (1)

20892

RECRUITING

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH