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

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About the trial

Background: Genitourinary cancers are some of the most common types of cancer. They are lethal when they spread. The drug M7824 blocks the paths that cancer cells use to stop the immune system from fighting cancer. The drug PDS01ADC triggers the immune system to fight cancer. Researchers want to learn if these drugs can help fight these cancers when given with and without Stereotactic Body Radiation Therapy (SBRT) radiation. Objective: To learn if M7824 and PDS01ADC, with or without SBRT, can help the immune system to fight cancer better. Eligibility: People 18 and older with cancer that started in the bladder, kidneys, or other genitourinary organs (but not the prostate) and has spread to other parts of the body. Design: Participants will be screened with: medical history physical exam ability to do their normal activities blood tests urine tests electrocardiogram body scans. Participants will give a tumor sample or have a tumor biopsy. Screening tests will be repeated during the study. Participants will get PDS01ADC . It is injected under the skin every 4 weeks. They will also get M7824 through an intravenous (IV) infusion every 2 weeks. For this, a small plastic tube is put into a vein in the arm. They will get these drugs in 28-day cycles until they leave the study. They may have SBRT. Participants will give tissue and saliva samples. Participants will have a follow-up visit 30 days after treatment ends. Then they will get phone calls or emails every 12 weeks indefinitely.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Wiek 18 lat lub więcej
  • Potwierdzony nowotwór rozsiany (rozprzestrzeniający się) z pęcherza moczowego, nerek lub innych narządów moczowo-płciowych (oprócz prostaty)
  • Nowotwór widoczny na badaniach obrazowych wykonanych w ciągu 21 dni przed włączeniem do badania
  • Co najmniej jedno miejsce nowotworu, które można zmierzyć na badaniach obrazowych
  • Możliwość wcześniejszego leczenia chemioterapią lub innymi lekami celowanymi
  • Możliwość wcześniejszego leczenia radioterapią
  • Możliwość wcześniejszego leczenia lekami wspierającymi układ odpornościowy (poza M7824 i PDS01ADC)

✗ Disqualifies

  • Wcześniejsze leczenie M7824 lub PDS01ADC
  • Dla chorych na raka nerki: brak wcześniejszego leczenia lub odmowa zalecanymi lekami pierwszego wyboru

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Maximum age
120 Years
Last updated (source)
August 18, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

National Institutes of Health Clinical Center

Bethesda, United States

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/11/2026.

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