NCT06503614 · John Sfakianos
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
(ENHANCE)
What this study is about
This is a phase 2 where both patients and doctors know the treatment given two group of participants study of durvalumab plus monalizumab in patients with BCG-unresponsive or BCG-exposed CIS NMIBC. treatment group$1 A will enroll 43 participants who have cancer in situ (CIS) with or without high grade papillary urothelial cancer.
View original scientific description
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.
Interventions
DRUG
Durvalumab
Durvalumab 1500mg IV
DRUG
Monalizumab
Monalizumab 1500mg IV
Primary outcome measures
Complete Response
Time frame: 6 months
Complete response will be determined by bladder biopsy and urinary cytology for malignancy for subjects with a CIS component at 6 months CT/MRI urography will be used to rule out extravesical disease. (Cohort A)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥18 years at the time of consent. 2. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. Able and willing to provide written informed consent. 3. Eastern Cooperative Oncology Group scores ≤ 1 within 28 days prior to registration. 4. Non-muscle-invasive bladder cancer
- Cohort A: CIS +/- high grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG.
- Cohort B: High grade papillary urothelial cancer (Ta or T1) after 3-mo evaluation after induction BCG. 5. Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible. NOTE: Pathology report required for documentation purposes. 6. Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (≥ 5 doses) and the first round of maintenance or
Where
- Tampa, Florida
- New Brunswick, New Jersey
- New York, New York
Collaborators
AstraZeneca, Icahn School of Medicine at Mount Sinai, Bladder Cancer Advocacy Network
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations