RecruitingPhase 1NCT04235777

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


Sponsor

National Cancer Institute (NCI)

Enrollment

100 participants

Start Date

Jul 13, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two immunotherapy drugs — bintrafusp alfa (M7824) and PDS01ADC — with or without radiation, in patients with advanced genitourinary cancers (such as bladder, kidney, or ureteral cancer) that have spread. **You may be eligible if...** - You have a confirmed metastatic genitourinary cancer (not prostate cancer) - Your cancer has progressed (worsened) and is visible on imaging - You have not been previously treated with M7824 or PDS01ADC - You may have received prior chemotherapy, targeted therapy, or immunotherapy - You have at least one site of cancer that can be measured and another that can be irradiated (for some arms) **You may NOT be eligible if...** - You have prostate cancer - You have no measurable disease on imaging - A previously irradiated site cannot be re-irradiated - You have serious autoimmune conditions or organ failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic body radiation therapy (SBRT)

A fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and PDS01ADC

DRUGPDS01ADC

An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT

DRUGM7824

1200 mg administered IV every two weeks while on PDS01ADC and with or without SBRT


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT04235777


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