OncoMatch/Clinical Trials/NCT06470282
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
Official title: EV-PRIME: Phase Ib/II Study of Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy as a Bladder-Sparing Trimodality Therapy in Muscle Invasive Bladder Cancer
Is NCT06470282 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Pembrolizumab and Enfortumab Vedotin for bladder cancer.
Treatment: Enfortumab Vedotin · Pembrolizumab — This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Cancer type
Urothelial Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic immunotherapy or chemotherapy for urothelial cancer
Exception: prior systemic therapy >12 months prior allowed; prior BCG and intravesical treatments allowed
Prior treatment with systemic immunotherapy or chemotherapy for urothelial cancer. (with the exception of prior systematic therapy treatment >12 months prior). Note: Prior bacillus calmette-guerin (BCG) and intravesical treatments are allowed
Cannot have received: allogeneic stem cell or solid organ transplant
Prior allogeneic stem cell or solid organ transplant.
Lab requirements
Blood counts
ANC ≥ 1,500/mcL; platelets ≥ 100,000/mcL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (without erythropoietin dependency and without pRBC transfusion within last 2 weeks)
Kidney function
Creatinine clearance (GFR) ≥ 30 mL/min/1.73 m², calculated by Cockcroft-Gault or measured using 24-hour creatinine clearance
Liver function
Total bilirubin ≤ 1.5 × ULN (unless Gilbert's syndrome and direct bilirubin is normal); AST ≤ 2.5 × ULN; ALT ≤ 2.5 × ULN
Demonstrates adequate organ function as defined below: Absolute neutrophil count ≥ 1,500/mcL. Platelets ≥ 100,000/mcL. Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L. Total bilirubin ≤ 1.5 × ULN, unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits. AST ≤ 2.5 × ULN. ALT ≤ 2.5 × ULN. Creatinine clearance (GFR) ≥ 30 mL/min/1.73 m². INR or PT ≤ 1.5 × ULN. aPTT ≤ 1.5 × ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06470282 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic immunotherapy or chemotherapy for urothelial cancer, allogeneic stem cell or solid organ transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages