A Study of Durvalumab Plus Monalizumab for Non-Muscle-Invasive Bladder Cancer
This study is testing a combination of two drugs, durvalumab and monalizumab, for people with non-muscle-invasive bladder cancer (NMIBC). This type of cancer has not spread into the bladder muscle. The study is for individuals whose cancer has either not responded to BCG treatment or who have previously received BCG. Researchers want to see if this drug combination can lead to a "complete response" (meaning the cancer is no longer detectable) after 6 months. You may be able to join if you are at least 18 years old and meet other health criteria. The study is currently unclear about its recruitment status.
- Study design
- This is a Phase 2, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 60 participants into two groups.
- What's involved
- You would receive up to 13 cycles of monthly intravenous (IV) infusions of both monalizumab and durvalumab, administered every 28 days.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures complete response at 6 months, suggesting follow-up for at least this duration.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06503614
A Trial of Durvalumab (MEDI4736) Plus Monalizumab in Non-Muscle-Invasive Bladder Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentJohn SfakianosInvestigator-initiated
~60 participants
Updated 2026-09-14 on ClinicalTrials.gov
What's tested:DurvalumabMonalizumab
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Response
Measured over 6 months
Conditions
NCT06503614
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Icahn School of Medicine at Mount Sinai
New York, New Yorkstudy coordinator listed
Recruiting
Moffitt Cancer Center
Tampa, Floridastudy coordinator listed
Recruiting
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jerseystudy coordinator listed
Recruiting
University of California San Francisco
San Francisco, Californiastudy coordinator listed
Recruiting
Weill Cornell Medical Center
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- John Sfakianos, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
Who to contact
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Eligibility criteria
Inclusion
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. Patients can have BCG-unresponsive or BCG-exposed NMIBC11. 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.
BCG-unresponsive is defined as high grade persistent or recurrent NMIBC that has not achieved a disease-free status after an adequate course of BCG therapy. This includes patients with:
Persistent or recurrent high-grade tumors (Ta/T1) or carcinoma in situ (CIS) within 6 to 12 months of completing adequate BCG therapy.
Recurrent high-grade papillary disease within 6 months of BCG therapy.
High-grade T1 disease found at the first evaluation after BCG induction therapy alone.
BCG-exposed is defined as high grade NMIBC that has recurred after an initial response or is still present after initial treatment, but recurrence is never too late to be considered "BCG-unresponsive". This includes patients with:
High-grade recurrence between 12 and 24 months after adequate BCG therapy.
Recurrence within 24 months of inadequate BCG therapy.
High-risk recurrence at the 3-month mark after an initial BCG induction.
High grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible. The recurrence must be within 6 months of the last BCG dose. 7. Patients may have received up to 2 lines of prior therapy (including chemotherapy or other approved agents) for NMIBC (NOTE: prior PD-1/PD-L1 blockade is prohibited). 8. Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy. NOTE: Reason for being deemed unfit or refusal should be documented in the medical record. 9. All visible tumor must be completely resected within 60 days prior to registration (residual pure CIS is permitted).
All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urine cytology within 28 days prior to registration (positive cytology is allowed in patients with CIS). 10. All patients with T1 tumors must undergo restaging TURBT within 60 days prior to registration.
There must be uninvolved muscularis propria in the restaging TURBT specimen.
The initial TURBT prior to the restaging TURBT may be \> 60 days prior to registration. 11. Patients must have baseline tumor tissue from either initial or repeat TURBTs for submission of a minimum of 2 and up to 10 unstained slides for translational study objectives. If archival tissue is not available, the subject is not eligible. 12. 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. The patient's estimated CrCl will be calculated by the local laboratory (for eligibility purposes) using screening/baseline height (m), actual weight (kg), and serum creatinine:
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician. 26. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. 27. History of leptomeningeal carcinomatosis 28. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment. 29. Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
Systemic corticosteroids at physiologic doses not to exceed \<\<10 mg/day\>\> of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication
Exclusion
On effective anti-retroviral therapy with undetectable viral load within 6 months of registration.
HIV-infected participants must not have a history of Kaposi sarcoma and/or Multicentric Castleman Disease. 17. Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV infection (defined as the presence of anti HBc and absence of HBsAg) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA. NOTE: No testing for Hepatitis B and Hepatitis C is required unless mandated by a local health authority. 18. Participants with a known co-infection with HBV and HCV, or co-infection with HBV and HDV, namely: HBV positive (presence of HBsAg and/or anti HBcAb with detectable HBV DNA); AND HCV positive (presence of anti-HCV antibodies); OR HDV positive (presence of anti-HDV antibodies). 19. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 20. Received live vaccines within 30 days of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted. 21. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug. Note: Local surgery of isolated lesions for palliative intent is acceptable. 22. Uncontrolled intercurrent illness, including but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 23. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart). 24. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control.
What this trial measures
- Complete Response6 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)