OncoMatch/Clinical Trials/NCT05239624
Enfortumab Vedotin and Pembrolizumab in People With Bladder Cancer
Is NCT05239624 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Enfortumab vedotin and Pembrolizumab for urothelial carcinoma.
Treatment: Enfortumab vedotin · Pembrolizumab — This study will test whether enfortumab vedotin combined with pembrolizumab is an effective treatment for people with bladder cancer (urothelial carcinoma) involving the lymph nodes who are going to have surgery to remove their cancer (cystectomy). The researchers will look at whether treatment with enfortumab vedotin and pembrolizumab before surgery can get rid of cancer within the lymph nodes. They will also try to find out if this combination of drugs is effective at shrinking participants' cancer before their surgery. The researchers think that a combination of enfortumab vedotin and pembrolizumab may help people with this disease because both drugs are designed to help the immune system attack and kill cancer cells. The researchers think the drugs may be more effective if given in combination rather than on their own.
Check if I qualifyExtracted eligibility criteria
Cancer type
Urothelial Carcinoma
Disease stage
Required: Stage T2-T4, N1-N3, M0, CT1, N2-N3, M0
Clinical Stage T2-T4, N1-N3, M0 OR cT1, N2-N3, M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to allocation.
Cannot have received: antibody-drug conjugate
Prior treatment with an antibody drug conjugate for bladder cancer directed therapy
Cannot have received: systemic chemotherapy
Exception: prior intravesical therapy is allowed
Prior systemic chemotherapy (prior intravesical therapy is allowed)
Cannot have received: radiation therapy
Exception: prior radiation therapy to the bladder
Prior radiation therapy to the bladder
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥1500/μL; Platelets ≥100 000/μL; Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L
Kidney function
eGFR ≥ 30 ml/min/1.73 m2 using the CKD-EPI equation; GFR or CrCl of ≥ 30 mL/min
Liver function
Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN
Have adequate organ function as defined in the following table (Table 1)...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baptist Alliance MCI · Miami, Florida
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering -Nassau · Commack, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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