NCT07061964|RecruitingPhase 2FDA Drug

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

Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2025-04663S2427U10CA180888

Study Type

interventional

Target

111

Locations

1 country

Sites

143

Timeline

RegisteredJul 2025

StartedNov 2025

CompletionJul 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

111

participants targeted

Target at P50-P75 for phase_2

Timeline

13mo left

Started Nov 2025

Geographic Reach

1 country

143 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Progress33%

Nov 2025Jul 2027

First Submitted

Initial submission to the registry

July 11, 2025

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed

4 months until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 11, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

July 11, 2025

Last Update Submit

June 10, 2026

Conditions

Stage IIIA Bladder Cancer AJCC v8 Stage II Bladder Cancer AJCC v8 Muscle Invasive Bladder Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

Bladder intact event-free survival (BI-EFS)
Will be evaluated as the percentage of participants who do not experience a BI-EFS event using a Kaplan-Meier estimate. A single-arm test of proportions will be used to test against the null hypothesis (true BI-EFS = 55%). Standard errors will be calculated using Greenwood's formula. If the upper bound of the one-sided 90% confidence interval includes 70%, then the radiation therapy + pembrolizumab regimen will be concluded to be active in this population.
Within 3 years after registration

Secondary Outcomes (6)

BI-EFS
From registration to the first documentation of a BI-EFS event, assessed up to 5 years
Local muscle invasive recurrence-free survival
From date of registration to first radiologic or histologic evidence of local muscle invasive bladder carcinoma recurrence, assessed up to 5 years
Metastasis-free survival
From date of registration to first radiologic or histologic evidence of metastatic disease or death due to any cause, assessed up to 5 years
Overall survival
From date of registration to date of death due to any cause, assessed up to 5 years
Salvage cystectomy
Up to 5 years
+1 more secondary outcomes

Other Outcomes (1)

Patient reported adverse events
Up to 5 years

Study Arms (1)

Treatment (photon beam RT, pembrolizumab)

EXPERIMENTAL

Patients undergo photon beam RT QD on Monday-Friday for up to 20 treatments and receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo TURBT with tissue sample collection at pre-registration and CT, MRI or PET, cystoscopy, and urine and blood sample collection throughout the study.

Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: CystoscopyProcedure: Magnetic Resonance ImagingBiological: PembrolizumabRadiation: Photon Beam Radiation TherapyProcedure: Positron Emission TomographyOther: Questionnaire AdministrationProcedure: Transurethral Resection of Bladder Tumor

Interventions

Positron Emission TomographyPROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT