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Clinical trial discovery in plain English. Data sourced from ClinicalTrials.gov.

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Take two experimental medications, with or without targeted radiation therapy | stella

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Testing two new drugs with or without radiation for advanced bladder and kidney cancers

Plain-English translation of NCT04235777 on ClinicalTrials.gov ↗ · Source last updated June 2026 · Translation generated June 2026 · How we translate trials

Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.

What is this trial?

This trial is testing a combination of two experimental drugs—bintrafusp alfa () and —to treat advanced bladder, kidney, and other urinary cancers that have spread in the body. The medication works by helping your immune system find and fight cancer cells. Some participants will also receive targeted radiation therapy to specific tumor sites.

Current immunotherapy drugs only work for about 15 to 25 percent of patients with these cancers. This trial is exploring whether combining the two medications—with or without radiation—can help more patients respond to treatment and live longer.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced bladder, kidney, or other urinary cancers that have spread to other parts of your body
you have measurable cancer that can be tracked on imaging scans
you are at least 18 years old
you have received, declined, or are ineligible for standard cancer treatments for your cancer type
you have adequate organ and bone marrow function (measured by blood tests)

You likely don't qualify if…

you have previously received M7824 or PDS01ADC
you have very low blood cell counts (fewer than 2,500 white blood cells, 1,500 neutrophils, or 100,000 platelets per microliter)
you have significantly impaired liver function
you have poor overall health or performance status (ECOG greater than 2)

What participation looks like

You will receive infusions of the two medications on a regular schedule. Depending on which study group you join, you may also receive a form of focused radiation therapy targeting specific tumors. You will have frequent blood tests and imaging scans to monitor how well the treatment is working and to check for side effects. The study involves multiple clinic visits over several months.

AI-generated summary from trial data · Jun 27, 2026 · Not medical advice

Trial locations(1 site)

United States

National Institutes of Health Clinical Center, Bethesda, Maryland

Key details

Phase

Safety & dosing

Sponsor

National Cancer Institute (NCI)

Enrollment target

~100 participants

Started

July 2020

Primary completion

December 2027

Age range

18 Years – 120 Years

Last updated on clinicaltrials.gov in June 2026.

Contact the research team directly

Reach out to the team running this trial. Response times vary — some teams are faster than others.

Central contact

Lisa Ley, R.N.

National Cancer Institute (NCI)

Interested in joining?

Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.

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View full record on ClinicalTrials.gov