Actively Recruiting
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Led by John Sfakianos · Updated on 2026-04-08
60
Participants Needed
4
Research Sites
408 weeks
Total Duration
On this page
Sponsors
J
John Sfakianos
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Able and willing to follow the study protocol, including treatment and visits
- Eastern Cooperative Oncology Group (ECOG) score 0 or 1 within 28 days before registration
- Diagnosis of non-muscle-invasive bladder cancer with either:
- Cohort A: carcinoma in situ (CIS) with or without high grade papillary urothelial cancer after BCG treatment
- Cohort B: high grade papillary urothelial cancer without CIS after BCG treatment
- Mixed variant histology allowed (adenocarcinoma, squamous cell carcinoma); pure variant histology not allowed
- BCG-unresponsive or BCG-exposed NMIBC as defined by study criteria
- Up to 2 prior therapies for NMIBC allowed; prior PD-1/PD-L1 blockade not allowed
- Deemed unfit for or refuse radical cystectomy
- Complete resection of all visible tumors within 60 days prior to registration (residual pure CIS allowed)
- Cystoscopy or TURBT without papillary tumor and negative urine cytology (except CIS) within 28 days before registration
- Restaging TURBT for T1 tumors within 60 days prior to registration with uninvolved muscularis propria
- Baseline tumor tissue available for study slides
- Adequate organ function as defined by blood counts, liver and kidney tests within 28 days before registration
- Negative pregnancy test for females of childbearing potential within 7 days before registration
- Agreement to use contraception during the study if of reproductive potential
- Life expectancy of at least 12 weeks
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or similar immune therapies
- Prior CIS in ureters or prostatic urethra within 24 months before registration
- Evidence of metastatic disease on recent imaging
- Body weight 30 kg or less
- History of allogeneic organ transplant
- Another primary cancer within 5 years prior to study start, except certain low-risk or treated cancers
- Participation in another investigational trial within 4 weeks before study treatment
- Active autoimmune or inflammatory disorders requiring systemic treatment within 24 months, with some exceptions
- Immunodeficiency or recent use of high-dose immunosuppressive therapy
- Psychiatric or substance abuse issues interfering with study compliance
- Active tuberculosis or recent symptomatic herpes zoster infection
- Active infection requiring systemic therapy
- History of certain lung diseases or pneumonitis
- Known HIV infection with exceptions
- Active hepatitis infections with some exceptions
- Allergy to study drugs or excipients
- Recent live vaccinations within 30 days before treatment
- Major surgery within 28 days before first study dose, except local palliative surgery
- Uncontrolled serious illnesses or conditions that increase risk or impair consent
- Prolonged QT interval on ECG
- Pregnant or breastfeeding females or those unwilling to use effective birth control
- Unresolved significant toxicity from previous cancer treatments
- Concurrent chemotherapy or biologic cancer treatments
- History of leptomeningeal carcinomatosis
- Prior participation in durvalumab clinical trials
- Use of immunosuppressive medications within 14 days before first durvalumab dose, with some exceptions
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
4
Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
Research Team
J
John Sfakianos, MD
CONTACT
A
Ahran Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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