Actively Recruiting
Phase I Study of Bintrafusp Alfa (M7824) and PDS01ADC With or Without Stereotactic Body Radiation Therapy in Adults With Metastatic Non-Prostate Genitourinary Cancers
Led by National Cancer Institute (NCI) · Updated on 2026-06-05
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults with metastatic non-prostate genitourinary cancers, including cancers starting in the bladder, kidneys, or other related organs. The study aims to learn if the drugs M7824 and PDS01ADC, given alone or with Stereotactic Body Radiation Therapy (SBRT), can help the immune system fight cancer more effectively. This is a phase I trial focusing on safety, dosage, and potential benefits of combining these treatments, especially since current immune therapies only help some patients. Participants receive PDS01ADC as a subcutaneous injection every 4 weeks and M7824 as an intravenous infusion every 2 weeks. Treatment cycles last 28 days and continue until participants leave the study. Some participants also receive SBRT radiation either sequentially or concurrently with the drug treatments. The study includes three groups: one with the drugs alone, one with drugs plus sequential SBRT, and one with drugs plus concurrent SBRT. Dose adjustments for PDS01ADC may occur based on side effects. During the study, participants undergo screening and repeated tests including medical history review, physical exams, blood and urine tests, electrocardiograms, body scans, and tumor biopsies or samples. Tissue and saliva samples are also collected. After treatment ends, there is a follow-up visit 30 days later, then ongoing contact every 12 weeks. Researchers primarily measure safety and tolerability of the treatments, while also tracking progression-free survival, overall survival, and tumor response.
CONDITIONS
Brief 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...
- Diagnosis of metastatic non-prostate genitourinary cancer confirmed by biopsy or cytology
- Presence of new or progressive metastatic lesions on imaging within 21 days before enrollment
- At least one measurable cancer site not planned for radiation treatment
- For some participants, at least one site of disease suitable for radiation (up to 4 sites)
- Age 18 years or older
- ECOG performance status 0 to 2 or Karnofsky score 60% or higher
- Adequate organ and marrow function including blood counts and liver enzymes
- Prior chemotherapy, radiation, or immunotherapy allowed except previous treatment with M7824 or PDS01ADC
- Pre-treatment tissue sample available for PD-L1 testing
- Stable HIV on treatment with undetectable viral load, if applicable
- Prior treated brain metastases allowed if recovered and off steroids
- Ability to understand and sign informed consent
You will not qualify if you...
- Allergic reaction history to compounds similar to M7824 or PDS01ADC
- Uncontrolled illnesses such as heart failure, unstable angina, arrhythmia, or psychiatric conditions limiting study compliance
- History of significant bleeding disorders except hematuria
- Unwillingness to accept blood products if medically needed
- Pregnancy or nursing
- Active or recent autoimmune diseases requiring systemic corticosteroids or immunosuppressants
- Active inflammatory bowel disease, lupus, scleroderma, or genetic radiosensitivity syndromes unless cleared by investigator
- Active second cancers other than certain skin or prostate cancers unless disease free for 2 years
- Tumor lesions in liver or chest measuring 10 cm or larger
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 4-week cycles until disease progression, unacceptable toxicity, or trial withdrawal
Participants receive treatment with M7824 and PDS01ADC with or without stereotactic body radiation therapy (SBRT). M7824 is administered intravenously every two weeks, PDS01ADC is given subcutaneously every 4 weeks, and SBRT is delivered as 8 Gy x 3 fractions either sequentially or concurrently.
Visits every 2 weeks for M7824 infusion and every 4 weeks for PDS01ADC injection; SBRT delivered in 3 fractions as scheduled during treatment
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.
A
Andrea B Apolo, M.D.
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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