OncoMatch/Clinical Trials/NCT04235777
Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies
Is NCT04235777 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including PDS01ADC and M7824 for urothelial cancer.
Treatment: PDS01ADC · M7824 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: VEGFR inhibitor or immune checkpoint inhibitor or tyrosine kinase inhibitor (axitinib plus pembrolizumab, cabozantinib plus nivolumab, levantinib plus pembrolizumab, axitinib plus avelumab, nivolumab plus ipilumumab, cabozantinib, pazopanib, sunitinib, axitinib) — locally advanced/metastatic clear cell renal cell cancer
Participants with locally advanced/metastatic clear cell renal cell cancer must have previously received, refused or been ineligible for either axitinib plus pembrolizumab, cabozantinib plus nivolumab, levantinib plus pembrolizumab, axitinib plus avelumab, nivolumab plus ipilumumab, cabozantinib, pazopanib, sunitinib or axitinib.
Must have received: platinum-based chemotherapy or autologous hematopoietic cell transplantation (bleomycin plus etoposide plus cisplatin, etoposide plus cisplatin, etoposide plus ifosfamide plus cisplatin, vinblastine plus ifosfamide plus cisplatin, paclitaxel plus ifosfamide plus cisplatin, autologous hematopoietic cell transplantation) — locally advanced or metastatic germ cell tumors
Participants with locally advanced or mestastatic germ cell tumors must have received, refused or been ineligible for prior bleomycin plus etoposide plus cisplatin, etoposide plus cisplatin, etoposide plus ifosfamide plus cisplatin, vinblastine plus ifosfamide plus cisplatin, paclitaxel plus ifosfamide plus cisplatin or autologous hematopoietic cell transplantation.
Must have received: platinum-based chemotherapy or anti-PD-1/PD-L1 therapy (platinum chemotherapy, single agent PD-1/PD-L1 inhibitor) — locally advanced/metastatic urothelial cancer
Participants with locally advanced/metastatic urothelial cancer must have previously received, refused or been ineligible for platinum chemotherapy and/or single agent PD-1/PD-L1 inhibitor.
Cannot have received: M7824
excluding prior treatment with M7824
Cannot have received: PDS01ADC
excluding prior treatment with ... PDS01ADC
Lab requirements
Blood counts
leukocytes >= 2500/mcL; absolute neutrophil count >= 1500/mcL; platelets >= 100,000/mcL; Hemoglobin >= 9g/dL (pRBC transfusions allowed)
Kidney function
Calculated Creatinine clearance >= 20 mL/min (CKD-EPY equation)
Liver function
AST/ALT <= 1.5x ULN; for liver involvement: AST <= 5.0x ULN, ALT <= 5.0x ULN, bilirubin <= 3.0x ULN; mild to moderate hepatic impairment with total bilirubin <= 3.0x ULN allowed
adequate organ and marrow function as defined below: leukocytes >= 2500mcL, ANC >= 1500/mcL, platelets >= 100,000/mcL, AST/ALT <= 1.5 X ULN, Hgb >= 9g/dL (pRBC transfusions allowed); mild to moderate hepatic impairment with total bilirubin <= 3.0 x ULN; for liver involvement: AST <= 5.0 x ULN, ALT <= 5.0 x ULN, bilirubin <= 3.0 x ULN; Creatinine clearance >= 20 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify