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

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

Trial Details

NCT ID
NCT04235777
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Stereotactic body radiation therapy (SBRT)
  • PDS01ADC
  • M7824
Locations (sample)
  • Bethesda, Maryland, United States|38.98067,-77.10026

Key Eligibility Criteria

  • Participants must have histologically or cytologically confirmed diagnosis of a metastatic non-prostate genitourinary tumor.
  • Participants must have metastatic disease defined as new or progressive lesions on cross-sectional imaging. Radiological evaluation should occur wi…
  • Participants must have evaluable or measurable disease, per RECIST 1.1.
  • Participants in Arms 2 and 3 must have at least one site of disease that is amenable to irradiation (irradiation of up to 4 different sites is perm…

For full eligibility, visit ClinicalTrials.gov.

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