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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Non-muscle-invasive Bladder Cancer
• Intervention / Treatment: Biological: Durvalumab (MEDI4736); Biological: Bacillus Calmette-Guerin (BCG)

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.

• Study Type: Interventional
• Enrollment (Actual): 1018
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Auchenflower, Australia, 4066
    • Research Site
  • Box Hill, Australia, 3128
    • Research Site
  • Brisbane, Australia, 4122
    • Research Site
  • Kogarah, Australia, 2217
    • Research Site
  • Orange, Australia, 2800
    • Research Site
  • Parkville, Australia, 3000
    • Research Site
  • Westmead, Australia, 2145
    • Research Site
  • Wollongong, Australia, 2500
    • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
  • Innsbruck, Austria, 6020
    • Research Site
  • Linz, Austria, 4020
    • Research Site
  • Salzburg, Austria, 5020
    • Research Site
  • Vienna, Austria, 1090
    • Research Site
• Belgium
  • Brussels, Belgium, 1070
    • Research Site
  • Ghent, Belgium, 9000
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Roeselare, Belgium, 8800
    • Research Site
• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 3J7
      • Research Site
    • Toronto, Ontario, Canada, M5G 2M9
      • Research Site
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Research Site
    • Montreal, Quebec, Canada, H2X 3E4
      • Research Site
    • Québec, Quebec, Canada, G1J 1Z4
      • Research Site
• France
  • Amiens, France, 80054
    • Research Site
  • Angers, France, 49033
    • Research Site
  • Bordeaux, France, 33076
    • Research Site
  • Lyon, France, 69437
    • Research Site
  • Marseille, France, 13003
    • Research Site
  • Montpellier, France, 34295
    • Research Site
  • Strasbourg, France, 67098
    • Research Site
  • Suresnes, France, 92151
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Research Site
  • Cologne, Germany, 50968
    • Research Site
  • Duisburg, Germany, 47169
    • Research Site
  • Hanover, Germany, 30625
    • Research Site
  • Heidelberg, Germany, 69120
    • Research Site
  • Marburg, Germany, 35043
    • Research Site
  • Mettmann, Germany, 40822
    • Research Site
  • Mühlheim An Der Ruhr, Germany, 45468
    • Research Site
  • München, Germany, 81377
    • Research Site
  • Münster, Germany, 48149
    • Research Site
  • Nürtingen, Germany, 72622
    • Research Site
  • Wesel, Germany, 46483
    • Research Site
  • Würselen, Germany, 52146
    • Research Site
  • Zirndorf, Germany, 90513
    • Research Site
• Japan
  • Bunkyō City, Japan, 113-8603
    • Research Site
  • Fukuoka, Japan, 812-8582
    • Research Site
  • Hirosaki-shi, Japan, 036-8563
    • Research Site
  • Kanazawa, Japan, 920-8641
    • Research Site
  • Kita-gun, Japan, 761-0793
    • Research Site
  • Koshigaya-shi, Japan, 343-8555
    • Research Site
  • Kōtoku, Japan, 135-8550
    • Research Site
  • Matsuyama, Japan, 791-0280
    • Research Site
  • Miyazaki, Japan, 889-1692
    • Research Site
  • Nagasaki, Japan, 852-8501
    • Research Site
  • Nagoya, Japan, 467-0001
    • Research Site
  • Okayama, Japan, 700-8558
    • Research Site
  • Osaka, Japan, 545-8586
    • Research Site
  • Osaka, Japan, 541-8567
    • Research Site
  • Osakasayama-shi, Japan, 589-8511
    • Research Site
  • Sapporo, Japan, 060-8543
    • Research Site
  • Shinjuku-ku, Japan, 160-8582
    • Research Site
  • Toyama, Japan, 930-0194
    • Research Site
  • Tsukuba, Japan, 305-8576
    • Research Site
  • Yokohama, Japan, 232-0024
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Research Site
  • Breda, Netherlands, 4818 CK
    • Research Site
  • Utrecht, Netherlands, 3543 AZ
    • Research Site
• Poland
  • Bialystok, Poland, 15-950
    • Research Site
  • Gdansk, Poland, 80-952
    • Research Site
  • Grudziądz, Poland, 86-300
    • Research Site
  • Koszalin, Poland, 75-581
    • Research Site
  • Piotrkow Trybunalski, Poland, 97-300
    • Research Site
  • Poznan, Poland, 61-731
    • Research Site
  • Warsaw, Poland, 02-781
    • Research Site
  • Warsaw, Poland, 02-005
    • Research Site
  • Wroclaw, Poland, 50-556
    • Research Site
  • Wroclaw, Poland, 53-413
    • Research Site
• Russia
  • Ivanovo, Russia, 153040
    • Research Site
  • Krasnoyarsk, Russia, 660133
    • Research Site
  • Moscow, Russia, 105077
    • Research Site
  • Moscow, Russia, 115280
    • Research Site
  • Moscow, Russia, 125367
    • Research Site
  • Nizhny Novgorod, Russia, 603074
    • Research Site
  • Obninsk, Russia, 249036
    • Research Site
  • Omsk, Russia, 644013
    • Research Site
  • Saint Petersburg, Russia, 197758
    • Research Site
  • Saint Petersburg, Russia, 191014
    • Research Site
  • Saint Petersburg, Russia, 194354
    • Research Site
  • Saint Petersburg, Russia, 194017
    • Research Site
  • Saint Petersburg, Russia, 194044
    • Research Site
  • Saint Petersburg, Russia, 195271
    • Research Site
  • Vologda, Russia, 160012
    • Research Site
  • Yaroslavl, Russia, 150054
    • Research Site
• Spain
  • Badajoz, Spain, 06008
    • Research Site
  • Barcelona, Spain, 08036
    • Research Site
  • Barcelona, Spain, 08025
    • Research Site
  • Barcelona, Spain, 8003
    • Research Site
  • Barcelona, Spain, 08208
    • Research Site
  • Elche(Alicante), Spain, 03202
    • Research Site
  • Madrid, Spain, 28046
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Madrid, Spain, 08035
    • Research Site
  • Málaga, Spain, 29010
    • Research Site
  • Oviedo, Spain, 33011
    • Research Site
  • Pamplona, Spain, 31008
    • Research Site
  • Pozuelo de Alarcón, Spain, 28223
    • Research Site
  • Seville, Spain, 41009
    • Research Site
  • Seville, Spain, 41014
    • Research Site
  • Valencia, Spain, 46026
    • Research Site
  • Valencia, Spain, 46014
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Research Site
  • Glasgow, United Kingdom, G12 0YN
    • Research Site
  • Guildford, United Kingdom, CU2 7XX
    • Research Site
  • London, United Kingdom, NW1 2PG
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Research Site
  • London, United Kingdom, E1 1BB
    • Research Site
  • Sheffield, United Kingdom, S10 2JF
    • Research Site
  • Southampton, United Kingdom, S016 6YD
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Durvalumab plus BCG (induction + maintenance); Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy	Biological: Durvalumab (MEDI4736); Investigational product; Biological: Bacillus Calmette-Guerin (BCG); Standard of care
Experimental: Durvalumab plus BCG (induction only); Durvalumab (MEDI4736) plus Bacillus Calmette-Guerrin (BCG) combination therapy	Biological: Durvalumab (MEDI4736); Investigational product; Biological: Bacillus Calmette-Guerin (BCG); Standard of care
Active Comparator: BCG treatment (Standard of care therapy); Bacillus Calmette-Guerrin (BCG) standard of care treatment	Biological: Bacillus Calmette-Guerin (BCG); Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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	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	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	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.	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	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.	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	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.	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 time to development of upper tract urothelial carcinoma	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.	Up to 7 years
To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of Disease-free survival	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.	Up to 7 years
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	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	Up to 24 months
To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone in terms of OS5	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).	up to 5 years
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	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.	Up to 7 years
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 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.	Up to 7 years
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 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.	Up to 7 years
To assess the efficacy of durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone time to development of upper tract urothelial carcinoma	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.	Up to 7 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of Disease-free survival	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.	Up to 4 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of Proportion of patients alive and disease free at 24 months	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.	Up to 24 months
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of 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). The proportion of patients alive at 5 years (OS5)	Up to 7 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of any disease-free survival	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.	up to 5 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of time to MIBC and/or metastatic disease	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.	up to 5 yeas
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of time to cystectomy	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.	up to 5 years
To assess the efficacy of durvalumab + BCG (induction and maintenance) combination therapy compared to durvalumab + BCG (induction only) in terms of Time to development of upper tract urothelial carcinoma	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.	up to 5 years
Complete response rate (CRR) at 6 months using Investigator disease assessments	To assess the efficacy of durvalumab + BCG combination therapy compared to BCG (induction and maintenance) for patients with CIS prior to study entry or at baseline cystoscopy.	up to 6 months
EORTC QLQ-C30 and EORTC QLQ-NMIBC24	To assess disease-related symptoms and HRQoL in patients with NMIBC treated with durvalumab + BCG (induction and maintenance) combination therapy and durvalumab + BCG (induction only) combination therapy compared to BCG (induction and maintenance) alone and compared to each other using the EORTC QLQ-C30 questionnaire and the EORTC QLQ-NMIBC24 questionnaire	up to 5 years
PRO version of the CTCAE with approximately 19 items (PRO-CTCAE) symptoms in countries where language is available	To assess patient-reported treatment tolerability directly using specific PRO-CTCAE symptoms	up to 5 years
PK serum concentration of durvalumab	To assess the PK of durvalumab when used in combination with BCG treatment	up to 5 years
Presence of ADAs for durvalumab	To investigate the immunogenicity of durvalumab when used in combination with BCG treatment	up to 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of treatment-related adverse events as assessed by CTCAE v4.0 in patients receiving Durvalumab + BCG combination therapies compared to SoC	The safety and tolerability profile of Durvalumab + BCG combination therapies compared to SoC using vital signs, laboratory data, electrocardiograms (ECGs), and adverse event data.	Up to 4 years

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): April 3, 2025
• Study Completion (Estimated): October 3, 2028

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 18, 2018

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PD-L1; NMIBC; BCG; OS; Durvalumab; MEDI4736; DFS
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Urologic Neoplasms; Carcinoma; Urinary Bladder Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Biological Products; Complex Mixtures; Bacterial Vaccines; Vaccines; Tuberculosis Vaccines; BCG Vaccine; durvalumab
• Other Study ID Numbers: D419JC00001; 2017-002979-26 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes