NCT03528694 (POTOMAC) is a Phase 3 clinical trial of Durvalumab (MEDI4736) in Non-muscle-invasive Bladder Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT03528694?

NCT03528694 is sponsored by AstraZeneca.

What drugs are being tested in NCT03528694?

Interventions in NCT03528694: Durvalumab (MEDI4736), Bacillus Calmette-Guerin (BCG).

What condition does NCT03528694 study?

NCT03528694 studies Non-muscle-invasive Bladder Cancer.

Is NCT03528694 still recruiting?

NCT03528694 is currently active, enrolled. Last updated 14 April 2026.

Last reviewed 2026-04-14 · How we verify

NCT03528694: POTOMAC

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer

Active, enrolled Phase 3 Last updated 14 April 2026

What this trial tests

Phase 3 trial testing Durvalumab (MEDI4736) in Non-muscle-invasive Bladder Cancer in 1,018 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

14 May 2018

Primary endpoint
3 April 2025

3 October 2028

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,018
Start date	14 May 2018
Primary completion	3 April 2025
Estimated completion	3 October 2028
Sites	120 locations across France, Japan, Netherlands, Russia, Belgium, Austria, United Kingdom, Germany

Drugs / interventions tested

Durvalumab (MEDI4736) — full drug profile →
Bacillus Calmette-Guerin (BCG) — full drug profile →

Conditions studied

Non-muscle-invasive Bladder Cancer — all drugs for Non-muscle-invasive Bladder Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Non-muscle-invasive Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Type I interferon-mediated tumor immunity and its role in immunotherapy.
Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
Vaccine Therapies for Cancer: Then and Now.
Morse MA, Gwin WR, Mitchell DA. · · 2021 · cited 156× · PMID 33512679 · DOI 10.1007/s11523-020-00788-w
Programmed death receptor (PD-)1/PD-ligand (L)1 in urological cancers : the "all-around warrior" in immunotherapy.
Liu Q, Guan Y, Li S. · · 2024 · cited 50× · PMID 39223527 · DOI 10.1186/s12943-024-02095-8
A Phase 1 Trial of Durvalumab in Combination with Bacillus Calmette-Guerin (BCG) or External Beam Radiation Therapy in Patients with BCG-unresponsive Non-muscle-Invasive Bladder Cancer: The Hoosier Cancer Research Network GU16-243 ADAPT-BLADDER Study.
Hahn NM, O'Donnell MA, Efstathiou JA, Zahurak M, et al · · 2023 · cited 45× · PMID 36717286 · DOI 10.1016/j.eururo.2023.01.017
Pathogen Molecular Pattern Receptor Agonists: Treating Cancer by Mimicking Infection.
Aleynick M, Svensson-Arvelund J, Flowers CR, Marabelle A, et al · · 2019 · cited 45× · PMID 31123052 · DOI 10.1158/1078-0432.ccr-18-1800
BCG therapy downregulates HLA-I on malignant cells to subvert antitumor immune responses in bladder cancer.
Rouanne M, Adam J, Radulescu C, Letourneur D, et al · · 2022 · cited 35× · PMID 35503263 · DOI 10.1172/jci145666
New Perspectives in the Medical Treatment of Non-Muscle-Invasive Bladder Cancer: Immune Checkpoint Inhibitors and Beyond.
Audisio A, Buttigliero C, Delcuratolo MD, Parlagreco E, et al · · 2022 · cited 28× · PMID 35159167 · DOI 10.3390/cells11030357
Novel immunotherapeutic options for BCG-unresponsive high-risk non-muscle-invasive bladder cancer.
Hannouneh ZA, Hijazi A, Alsaleem AA, Hami S, et al · · 2023 · cited 26× · PMID 38037752 · DOI 10.1002/cam4.6768

Verify or expand the search:

Other trials of Durvalumab (MEDI4736)

Trials testing the same drug.

NCT04293419 — Durvalumab (MEDI4736) Plus Total Neoadjuvant Therapy (TNT) in Locally Advanced Rectal Cancer · Phase 2 · unknown
NCT03853187 — Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer · Phase 2 · completed
NCT03101475 — Synergism of Immunomodulation and Tumor Ablation · Phase 2 · completed
NCT03003962 — Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL) · Phase 3 · active not recruiting

Other recruiting trials for Non-muscle-invasive Bladder Cancer

Currently open trials in the same condition.

NCT05796375 — Replacing Invasive Cystoscopy With Urine Testing for Non-muscle Invasive Bladder Cancer Surveillance · Phase 2 · recruiting
NCT07494864 — Effects of Microbiological and Immunological Factors on the Lower Urinary Tract · recruiting
NCT05519241 — A Phase I Intravesical PPM Therapy for NMIBC · Phase 1 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03528694 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 14 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03528694.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing