Phase I Study of Bintrafusp Alfa M7824 and PDS01ADC With or Without Stereotactic Body Radiation Therapy in Adults With Advanced Non-Prostate Genitourinary Cancers

What this Trial Is About

Researchers are investigating treatments for metastatic non-prostate genitourinary cancers, including bladder and kidney cancers. This phase I trial evaluates the safety and effects of two drugs, M7824 and PDS01ADC, with or without stereotactic body radiation therapy SBRT. These therapies aim to enhance the immune systems ability to fight cancer, especially in patients whose cancers have spread and may not respond well to current immunotherapies. Participants receive M7824 through intravenous infusion every two weeks and PDS01ADC via subcutaneous injection every four weeks in 28-day treatment cycles. Some participants may also receive SBRT radiation either sequentially or concurrently with the drugs. The trial includes three treatment groups drugs alone, drugs with sequential SBRT, and drugs with concurrent SBRT. Doses of PDS01ADC may be adjusted based on tolerance. Up to 66 participants will be enrolled. Throughout the study, participants undergo regular assessments including medical history reviews, physical exams, blood and urine tests, electrocardiograms, and imaging scans. Tumor samples and saliva are collected before and during treatment. After treatment ends, a follow-up visit occurs 30 days later, followed by ongoing monitoring through phone or email every 12 weeks. The main outcomes measured include safety, tolerability, progression-free survival, overall survival, and tumor response.

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