Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
POTOMAC
A Phase III Randomized, Open-Label, Multi-Center, Global Study of Durvalumab and Bacillus Calmette-Guerin (BCG) Administered as Combination Therapy Versus BCG Alone in High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer Patients
2 other identifiers
interventional
1,018
11 countries
115
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2018
Longer than P75 for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2018
CompletedStudy Start
First participant enrolled
May 14, 2018
CompletedFirst Posted
Study publicly available on registry
May 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2028
ExpectedApril 14, 2026
April 1, 2026
6.9 years
February 28, 2018
April 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC
Disease-free survival using Investigator disease assessments.
Up to 4 years
Secondary Outcomes (25)
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
Up to 4 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to BCG (induction and maintenance) alone in terms of OS5
Up to 7 years
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
Up to 7 years
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
Up to 4 years
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
Up to 4 years
- +20 more secondary outcomes
Study Arms (3)
Durvalumab plus BCG (induction + maintenance)
EXPERIMENTALDurvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
Durvalumab plus BCG (induction only)
EXPERIMENTALDurvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy
BCG treatment (Standard of care therapy)
ACTIVE COMPARATORBacillus Calmette-Guerrin (BCG) standard of care treatment
Interventions
Investigational product
Standard of care
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (120)
Research Site
Auchenflower, 4066, Australia
Research Site
Box Hill, 3128, Australia
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Brisbane, 4122, Australia
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Kogarah, 2217, Australia
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Orange, 2800, Australia
Research Site
Parkville, 3000, Australia
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Westmead, 2145, Australia
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Wollongong, 2500, Australia
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Graz, 8036, Austria
Research Site
Innsbruck, 6020, Austria
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Linz, 4020, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Brussels, 1070, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Roeselare, 8800, Belgium
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Kingston, Ontario, K7L 3J7, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Chicoutimi, Quebec, G7H 5H6, Canada
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Montreal, Quebec, H2X 3E4, Canada
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Québec, Quebec, G1J 1Z4, Canada
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Amiens, 80054, France
Research Site
Angers, 49033, France
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Bordeaux, 33076, France
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Lyon, 69437, France
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Marseille, 13003, France
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Montpellier, 34295, France
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Strasbourg, 67098, France
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Suresnes, 92151, France
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Berlin, 10117, Germany
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Cologne, 50968, Germany
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Duisburg, 47169, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Marburg, 35043, Germany
Research Site
Mettmann, 40822, Germany
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Mühlheim An Der Ruhr, 45468, Germany
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München, 81377, Germany
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Münster, 48149, Germany
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Nürtingen, 72622, Germany
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Wesel, 46483, Germany
Research Site
Würselen, 52146, Germany
Research Site
Zirndorf, 90513, Germany
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Bunkyō City, 113-8603, Japan
Research Site
Fukuoka, 812-8582, Japan
Research Site
Hirosaki-shi, 036-8563, Japan
Research Site
Kanazawa, 920-8641, Japan
Research Site
Kita-gun, 761-0793, Japan
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Koshigaya-shi, 343-8555, Japan
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Kōtoku, 135-8550, Japan
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Matsuyama, 791-0280, Japan
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Miyazaki, 889-1692, Japan
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Nagasaki, 852-8501, Japan
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Nagoya, 467-0001, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Osaka, 545-8586, Japan
Research Site
Osakasayama-shi, 589-8511, Japan
Research Site
Sapporo, 060-8543, Japan
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Shinjuku-ku, 160-8582, Japan
Research Site
Toyama, 930-0194, Japan
Research Site
Tsukuba, 305-8576, Japan
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Yokohama, 232-0024, Japan
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Amsterdam, 1081 HV, Netherlands
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Breda, 4818 CK, Netherlands
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Utrecht, 3543 AZ, Netherlands
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Bialystok, 15-950, Poland
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Gdansk, 80-952, Poland
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Grudziądz, 86-300, Poland
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Koszalin, 75-581, Poland
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Piotrkow Trybunalski, 97-300, Poland
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Poznan, 61-731, Poland
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Warsaw, 02-005, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 50-556, Poland
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Wroclaw, 53-413, Poland
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Ivanovo, 153040, Russia
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Krasnoyarsk, 660133, Russia
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Moscow, 105077, Russia
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Moscow, 115280, Russia
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Moscow, 125367, Russia
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Nizhny Novgorod, 603074, Russia
Research Site
Obninsk, 249036, Russia
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Omsk, 644013, Russia
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Saint Petersburg, 191014, Russia
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Saint Petersburg, 194017, Russia
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Saint Petersburg, 194044, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 195271, Russia
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Saint Petersburg, 197758, Russia
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Vologda, 160012, Russia
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Yaroslavl, 150054, Russia
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Badajoz, 06008, Spain
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Barcelona, 08025, Spain
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Barcelona, 08036, Spain
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Barcelona, 08208, Spain
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Barcelona, 8003, Spain
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Elche(Alicante), 03202, Spain
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Madrid, 08035, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Madrid, 28046, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Pamplona, 31008, Spain
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Pozuelo de Alarcón, 28223, Spain
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Seville, 41009, Spain
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Seville, 41014, Spain
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Valencia, 46014, Spain
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Valencia, 46026, Spain
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Birmingham, B15 2TH, United Kingdom
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Glasgow, G12 0YN, United Kingdom
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Guildford, CU2 7XX, United Kingdom
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London, E1 1BB, United Kingdom
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London, NW1 2PG, United Kingdom
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London, SE1 9RT, United Kingdom
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Sheffield, S10 2JF, United Kingdom
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Southampton, S016 6YD, United Kingdom
Research Site
Taunton, TA1 5DA, United Kingdom
Related Publications (1)
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.
PMID: 41115436DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2018
First Posted
May 18, 2018
Study Start
May 14, 2018
Primary Completion
April 3, 2025
Study Completion (Estimated)
October 3, 2028
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.