OncoMatch/Clinical Trials/NCT06503614
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Official title: ENHANCE (Elevated NKG2A and HLA-E Amplify NK/CD8 Checkpoint Engagers): A Phase 2 Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Is NCT06503614 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Durvalumab and Monalizumab for non-muscle invasive bladder cancer.
Treatment: Durvalumab · Monalizumab — This is a phase 2 open-label two cohort study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. Arm A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer. Arm B will enroll 17 participants who do not have cancer in situ (CIS) but do have high grade papillary urothelial cancer. Eligible patients will be enrolled to receive up to 13 cycles of monthly combination of monalizumab and durvalumab. Both monalizumab and durvalumab will be administered intravenously (IV) every 28 days.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Urothelial Carcinoma
Disease stage
Grade: high grade
CIS +/- high grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: BCG therapy — NMIBC
Adequate BCG therapy is defined as completing at least induction BCG (≥ 5 doses) and the first round of maintenance or second induction course BCG (≥ 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG.
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
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 (e.g., CTLA-4, OX 40, CD137).
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1500/µL; Platelets ≥ 100,000/µL; Hemoglobin ≥ 9 g/dL
Kidney function
Creatinine clearance ≥ 40 mL/min by Cockcroft-Gault estimation
Liver function
Aspartate aminotransferase/alanine aminotransferase ≤ 1.5× upper limit of normal (ULN); Total serum bilirubin ≤ 1.5×ULN*; *Patients with Gilbert's disease: ≤ 3×ULN
Adequate organ function as defined by ALL of the following within 28 days prior to registration: * Absolute neutrophil count ≥ 1500/µL * Platelets ≥ 100,000/µL * Hemoglobin ≥ 9 g/dL * Aspartate aminotransferase/alanine aminotransferase ≤ 1.5× upper limit of normal (ULN) * Total serum bilirubin ≤ 1.5×ULN*; *Patients with Gilbert's disease: ≤ 3×ULN * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5×ULN unless the patient is on therapeutic anticoagulation. * Creatinine clearance ≥ 40 mL/min by Cockcroft-Gault estimation.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California San Francisco · San Francisco, California
- Moffitt Cancer Center · Tampa, Florida
- Rutgers Cancer Institute of New Jersey · New Brunswick, New Jersey
- Icahn School of Medicine at Mount Sinai · New York, New York
- Weill Cornell Medical Center · New York, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06503614 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy 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