OncoMatch/Clinical Trials/NCT07061964
Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial
Is NCT07061964 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for muscle invasive bladder urothelial carcinoma.
Treatment: Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage CT2-T4AN0M0, T0-T1 (AJCC v8)
Excluded: Stage ≥ T2, N1-3
cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder; radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT; must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
Performance status
ZUBROD 0–2
Prior therapy
Must have received: neoadjuvant therapy (cisplatin-based combination chemotherapy, cisplatin and gemcitabine, methotrexate, vinblastine, doxorubicin, cisplatin, enfortumab vedotin, PD-1/L1 inhibitor) — neoadjuvant
Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine [GC] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
Cannot have received: anti-PD-1 therapy
Exception: neoadjuvant treatment for MIBC
Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC
Cannot have received: pelvic radiotherapy
Participants must not have had prior pelvic radiotherapy
Lab requirements
Blood counts
Leukocytes ≥ 3 x 10^3/uL; Absolute neutrophil count ≥ 1.5 x 10^3/uL; Platelets ≥ 100 x 10^3/uL
Kidney function
creatinine ≤ institutional ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min
Liver function
Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease; AST/ALT ≤ 3 x institutional ULN
Cardiac function
New York Heart Association Functional Classification class II or better
Leukocytes ≥ 3 x 10^3/uL; Absolute neutrophil count ≥ 1.5 x 10^3/uL; Platelets ≥ 100 x 10^3/uL; Total bilirubin ≤ institutional ULN unless history of Gilbert's disease; AST/ALT ≤ 3 x institutional ULN; creatinine ≤ institutional ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min; NYHA class II or better
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- Tower Cancer Research Foundation · Beverly Hills, California
- City of Hope Corona · Corona, California
- City of Hope Comprehensive Cancer Center · Duarte, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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