Actively Recruiting
Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
100
Participants Needed
1
Research Sites
385 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic non-prostate genitourinary tumor
- Metastatic disease with new or progressive lesions on imaging within 21 days before enrollment
- Presence of evaluable or measurable disease per RECIST 1.1 criteria
- For Arms 2 and 3, at least one site of disease suitable for irradiation (up to 4 sites allowed)
- At least one measurable site of disease not planned for irradiation
- May have received prior chemotherapy, targeted agents, or radiation therapy (re-irradiation only with approval)
- May have had prior immunotherapy excluding M7824 or PDS01ADC
- Specific prior treatments required for certain cancer types (renal cell, germ cell, urothelial cancers)
- Availability of pre-treatment tissue for PD-L1 expression testing or willingness to have a biopsy
- Male or female aged 18 years or older at consent
- ECOG performance status 0 to 2 (Karnofsky score ≥60%)
- Adequate organ and marrow function
- Mild to moderate hepatic impairment allowed with defined bilirubin levels
- Creatinine clearance ≥20 mL/min
- Agreement to use effective contraception during and after treatment
- HIV positive participants allowed if stable on therapy with CD4 >350 and undetectable viral load
- Participants with treated brain or CNS metastases meeting specific criteria
- Participants with treated hepatitis B or C under stable antiviral therapy
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergic reactions to M7824 or PDS01ADC or similar compounds
- Uncontrolled illnesses including serious heart conditions, unstable angina, arrhythmias, psychiatric illness, or bleeding risks (except hematuria)
- Refusal to accept blood products if medically needed
- Pregnant or nursing individuals
- Active or recent autoimmune disease needing systemic corticosteroids >10 mg prednisone daily or immunosuppressants
- Active inflammatory bowel disease, lupus, scleroderma, or genetic radiosensitivity syndromes unless approved
- Active second malignancy except certain skin cancers, cervical carcinoma in situ, or specific prostate cancer cases
- Tumor lesions in liver or chest measuring 10 cm or larger
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lisa Ley, R.N.
CONTACT
A
Andrea B Apolo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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