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NCT04235777 · ClinicalTrials.gov registry record · Phase 1
Bintrafusp Alfa (M7824) and PDS01ADC Alone and in Combination With Stereotactic Body Radiation Therapy (SBRT) in Adults With Metastatic Non-Prostate Genitourinary Malignancies
A Phase 1 study of Bladder Cancer and Urothelial Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT04235777: Recruiting Phase 1 study of Bladder Cancer and Urothelial Cancer, sponsored by National Cancer Institute (NCI).
NCT04235777 is a Phase 1 study of Bladder Cancer and Urothelial Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04235777, a Phase 1 study of Bladder Cancer and Urothelial Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
The fraction of participants with toxicity noted at each dose level will be reported by grade and type of toxicity identified. Maximum tolerated dose will also be reported.
Conditions Studied
Interventions
- DRUG PDS01ADC
- DRUG M7824
- RADIATION Stereotactic body radiation therapy (SBRT)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2020-07-13 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
What NCT04235777 shows while recruiting
NCT04235777 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 12,753-participant average among 175 other Bladder Cancer trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Bladder Cancer appearing as the primary indexed condition, and to 3 interventions - of which PDS01ADC is the first listed.
NCT04235777 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04235777 about?
NCT04235777 is a clinical study titled "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 le...
What is the current status of trial NCT04235777?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2020-07-13. Estimated completion is 2027-12-01.
What conditions does trial NCT04235777 study?
This clinical trial studies the following conditions: Bladder Cancer, Urothelial Cancer, Genitourinary Cancer, Urogenital Neoplasms, Urogenital Cancer.
What interventions are being tested in trial NCT04235777?
The interventions under investigation include: PDS01ADC (DRUG), M7824 (DRUG), Stereotactic body radiation therapy (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT04235777?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04235777 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04235777's enrollment target sits among peer trials
100 85th of 175 higher than 90 of 175 other Bladder Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bladder Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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