TriangleNCT03528694 · CITED IN SOURCE DOCUMENTS
Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-07
This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: * Aged at least 18 years * BCG-naïve (patients who have not received prior intravesical BCG or who previously received but stopped BCG more than 3 years before study entry are eligible) * Local histological confirmation (based on pathology report) of high-risk transitional cell carcinoma of the urothelium of the urinary bladder confined to the mucosa or submucosa. A high risk tumor is defined as one of the following * T1 tumor * High grade/ G3 tumor * CIS * Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point) * Complete resection of all Ta/T1 papillary disease prior to randomization, with the TURBT removing high-risk NMIBC performed not more than 4 months before randomization in the study. Patients with residual CIS after TURBT are eligible * No prior radiotherapy for bladder cancer * No prior exposure to immune-mediated therapy of cancer including, but not limited to, other anti CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies. Patients who have been treated with anticancer vaccines will be excluded Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: * Evidence of muscle-invasive, locally advanced, metastatic, and/or extra vesical bladder cancer (ie, T2, T3, T4, and / or stage IV) * Concurrent extravesical (ie, urethra, ureter, or renal pelvis), non-muscle-invasive transitional cell carcinoma of the urothelium * Previous investigational product (IP) assignment in the present study * Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for noncancer related conditions (eg, hormone replacement therapy) is acceptable. Chemotherapy for previous instances of NMIBC is acceptable. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician * Patients with celiac disease controlled by diet alone * History of another primary malignancy except for * Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of IP and of low potential risk for recurrence during the study period * Adequately treated nonmelanoma skin cancer or lentigo maligna withoutevidence of disease * Adequately treated CIS without evidence of disease * Prostate cancer (tumor/node/metastasis stage) of stage ≤ T2cN0M0 without biochemical recurrence or progression that in the opinion of the Investigator does not require active intervention * 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 (eg, 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 (eg, computed tomography \[CT\] scan premedication)
- healthy Volunteers
- false
- maximum Age
- 130 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
- intervention Names
- Biological: Durvalumab (MEDI4736)
- Biological: Bacillus Calmette-Guerin (BCG)
- label
- Durvalumab plus BCG (induction + maintenance)
- type
- EXPERIMENTAL
- description
- Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
- intervention Names
- Biological: Durvalumab (MEDI4736)
- Biological: Bacillus Calmette-Guerin (BCG)
- label
- Durvalumab plus BCG (induction only)
- type
- EXPERIMENTAL
- description
- Bacillus Calmette-Guerrin (BCG) standard of care treatment
- intervention Names
- Biological: Bacillus Calmette-Guerin (BCG)
- label
- BCG treatment (Standard of care therapy)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Durvalumab plus BCG (induction + maintenance)
- Durvalumab plus BCG (induction only)
- description
- Investigational product
- name
- Durvalumab (MEDI4736)
- type
- BIOLOGICAL
- arm Group Labels
- BCG treatment (Standard of care therapy)
- Durvalumab plus BCG (induction + maintenance)
- Durvalumab plus BCG (induction only)
- description
- Standard of care
- name
- Bacillus Calmette-Guerin (BCG)
- type
- BIOLOGICAL
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 1018
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- Disease-free survival using Investigator disease assessments.
- measure
- The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC
- time Frame
- Up to 4 years
- secondary Outcomes
- description
- Proportion of patients alive and disease free at 24 months using Investigator disease assessments. DFS24 is defined as the proportion of patients alive and disease-free at 24 months after randomization, per Investigator disease assessment.
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of DFS 24 months
- time Frame
- Up to 4 years
- description
- Overall survival at 5 years. Overall survival (OS) is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization +1). Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of OS5
- time Frame
- Up to 7 years
- description
- Any disease-free survival using Investigator disease assessments. Any disease-free survival (aDFS) is defined similarly as DFS, except that aDFS includes recurrence of low/medium risk NMIBC. This will be based on Investigator disease assessments.
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of any disease-free survival
- time Frame
- Up to 7 years
- description
- Time to MIBC and/or metastatic disease using Investigator disease assessments. Time to MIBC and/or metastatic disease is defined as the time from the date of randomization until the date of first documented MIBC and/or metastatic disease as assessed by Investigator. Time to MIBC and/or metastatic disease does not include deaths. If patients died without MIBC and/or metastatic disease, they will be censored at the time of death. All other censoring rules per DFS analysis will be applied including censoring patients with an event after 2 missed visits and patients with no evaluable disease assessments or no baseline data.
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of Time to MIBC and/or Metastatic Disease
- time Frame
- Up to 4 years
- description
- Time to cystectomy using Investigator disease assessments. Time to cystectomy is defined as the time from the date of randomization until the date of cystectomy as reported by Investigator. Patients who died prior to cystectomy will be censored at the time of death. Patients who have not had a cystectomy at the time of analysis will be censored at the last recorded date on which the patient was known to be alive. No other censoring rules per the DFS analysis will be applied.
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone with respect to time to cystectomy
- time Frame
- Up to 4 years
- description
- Time to development of upper tract urothelial carcinoma using Investigator disease assessments. Time to development of upper tract urothelial carcinoma (TTUTUC) is defined as the time from the date of randomization until the date of development of upper tract urothelial carcinoma as assessed by Investigator using CT urography or ureteroscopy (less common). TTUTUC does not include deaths. Patients who died without upper tract urothelial carcinoma will be censored at the time of death. Other censoring rules per DFS analysis will be applied, including censoring patients with no baseline data but excluding censoring patients with an event after 2 missed visits as evaluation of the upper urinary tract is not part of regular disease assessment and is performed as clinically indicated.
- measure
- To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of time to development of upper tract urothelial carcinoma
- time Frame
- Up to 7 years
- description
- Any disease-free survival (aDFS) is defined similarly as DFS, except that aDFS includes recurrence of low/medium risk NMIBC. This will be based on Investigator disease assessments.
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of Disease-free survival
- time Frame
- Up to 7 years
- description
- Proportion of patients alive and disease free at 24 months using Investigator disease assessments. DFS24 is defined as the proportion of patients alive and disease-free at 24 months after randomization, per Investigator disease assessment
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of patients alive and disease free at 24 months
- time Frame
- Up to 24 months
- description
- Overall survival at 5 years. Overall survival (OS) is defined as the time from the date of randomization until death due to any cause regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy (i.e. date of death or censoring - date of randomization +1).
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of OS5
- time Frame
- up to 5 years
- description
- Any disease-free survival using Investigator disease assessments. Any disease-free survival (aDFS) is defined similarly as DFS, except that aDFS includes recurrence of low/medium risk NMIBC. This will be based on Investigator disease assessments.
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of any disease-free survival
- time Frame
- Up to 7 years
- description
- Time to MIBC and/or metastatic disease using Investigator disease assessments. Time to MIBC and/or metastatic disease is defined as the time from the date of randomization until the date of first documented MIBC and/or metastatic disease as assessed by Investigator. Time to MIBC and/or metastatic disease does not include deaths. If patients died without MIBC and/or metastatic disease, they will be censored at the time of death. All other censoring rules per DFS analysis will be applied including censoring patients with an event after 2 missed visits and patients with no evaluable disease assessments or no baseline data.
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of Time to MIBC and/or metastatic disease
- time Frame
- Up to 7 years
- description
- Time to cystectomy using Investigator disease assessments. Time to cystectomy is defined as the time from the date of randomization until the date of cystectomy as reported by Investigator. Patients who died prior to cystectomy will be censored at the time of death. Patients who have not had a cystectomy at the time of analysis will be censored at the last recorded date on which the patient was known to be alive. No other censoring rules per the DFS analysis will be applied.
- measure
- To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of time to cystectomy
- time Frame
- Up to 7 years
Full study description
- brief Summary
- This is a randomized, open-label, multi-center, global, phase III study to determine the efficacy and safety of Durvalumab + BCG combination therapy in the treatment of patients with non-muscle-invasive bladder cancer
- detailed Description
- Patients will be randomized in a 1:1:1 ratio to receive treatment with Durvalumab + BCG combination therapies, or Standard of Care (SoC) therapy.
Source references
- references
- citation
- De Santis M, Palou Redorta J, Nishiyama H, Krawczynski M, Seyitkuliev A, Novikov A, Guerrero-Ramos F, Zukov R, Kato M, Kawahara T, Goeman L, Puente J, Hellmis E, Powles T, Radziszewski P, Gust KM, Vasey P, Bigot P, Fradet Y, Hunting J, Armstrong J, Boulos S, Hois S, Shore ND; POTOMAC Investigators. Durvalumab in combination with BCG for BCG-naive, high-risk, non-muscle-invasive bladder cancer (POTOMAC): final analysis of a randomised, open-label, phase 3 trial. Lancet. 2025 Nov 8;406(10516):2221-2234. doi: 10.1016/S0140-6736(25)01897-5. Epub 2025 Oct 17.
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Preserved source evidence · Not medical advice