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NCT07061964 · ClinicalTrials.gov registry record · Phase 2

Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial

A Phase 2 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
111
Enrollment target
20
Study locations

NCT07061964 is a Phase 2 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 111 participants, below the 292-participant average among 6 other Stage II Bladder Cancer AJCC v8 trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 5 states.

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The verdict

NCT07061964, a Phase 2 study of Stage II Bladder Cancer AJCC v8 and Stage IIIA Bladder Cancer AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
111 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Magnetic Resonance Imaging
  • PROCEDURE Cystoscopy

Study Locations (20)

California

  • Tower Cancer Research Foundation - Beverly Hills
  • City of Hope Corona - Corona
  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope at Irvine Lennar - Irvine
  • City of Hope Antelope Valley - Lancaster
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • Cedars Sinai Medical Center - Los Angeles
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • City of Hope South Pasadena - South Pasadena
  • Cedars-Sinai Cancer - Tarzana - Tarzana
  • City of Hope Upland - Upland

Colorado

  • Shaw Cancer Center - Edwards
  • Poudre Valley Hospital - Fort Collins
  • Cancer Care and Hematology-Fort Collins - Fort Collins
  • UCHealth Greeley Hospital - Greeley
  • Medical Center of the Rockies - Loveland

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix

Florida

  • Mayo Clinic in Florida - Jacksonville

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2025-11-25
Est. Completion 2027-07-31
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT07061964

The ClinicalTrials.gov registry entry for NCT07061964 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 6 other Stage II Bladder Cancer AJCC v8 trials with a reported enrollment target (62% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Stage II Bladder Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT07061964 reports 20 study locations spanning 5 distinct geographic areas - top geographies include California, Colorado, Alabama.

Frequently Asked Questions

What is clinical trial NCT07061964 about?

NCT07061964 is a clinical study titled "Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial". This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or ...

What is the current status of trial NCT07061964?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2025-11-25. Estimated completion is 2027-07-31.

What conditions does trial NCT07061964 study?

This clinical trial studies the following conditions: Stage II Bladder Cancer AJCC v8, Stage IIIA Bladder Cancer AJCC v8, Muscle Invasive Bladder Urothelial Carcinoma.

What interventions are being tested in trial NCT07061964?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Cystoscopy (PROCEDURE).

Who is sponsoring clinical trial NCT07061964?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07061964 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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