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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT04235777
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic body radiation therapy (SBRT) — RADIATION
    A fixed dose of 8 Gy x 3 fractions sequential or concurrent with M7824 and PDS01ADC
  • PDS01ADC — DRUG
    An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks while on M7824 and with or without SBRT
  • M7824 — DRUG
    1200 mg administered IV every two weeks while on PDS01ADC and with or without SBRT

Study Details

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.

Key Dates

Start date
Jul 13, 2020
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Treatment with M7824 and de-escalating doses of PDS01ADC if appropriate
  • Experimental: Arm 2
    Treatment with M7824 and de-escalating doses of PDS01ADC (if appropriate) with sequential SBRT
  • Experimental: Arm 3
    Treatment with M7824 and de-escalating doses of PDS01ADC (if appropriate) with concurrent SBRT

Primary Outcome Measure

safety and tolerability of PDS01ADC and M7824 alone or in combination with SBRT [ Time Frame: until confirmed progression, unacceptable toxicity or trial withdrawal ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office
888-624-1937

Find similar trials in Bethesda, MD

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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