A Phase III Randomized, Open-Label, Multi-Center, GlobalStudy of Durvalumab and Bacillus Calmette-Guerin (BCG)Administered as Combination Therapy Versus BCG Alone inHigh-Risk, BCG Naïve Non Muscle Invasive Bladder Cancer Patients (POTOMAC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505341-23-00

Acronym

D419JC00001(POTOMAC)

Enrollment

466

Registered

2024-03-12

Start date

2018-07-27

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle invasive bladder cancer

Brief summary

Disease-free survival (DFS)

Detailed description

Disease free at 24 months (DFS24) Survival at 5 years (OS5) Complete response rate (CRR) Any disease-free survival (aDFS) Time to muscle-invasive bladder (MIBC) cancer ormetastasis Time to cystectomy. Time to development of upper track urothelial carcinoma(UTUC) Disease related symptoms Patient reported treatment tolerability Assessment of PK of Durvalumab Immunogenicity of Durvalumab (ADA) in combination with BCG

Interventions

DRUGINFLIXIMAB

DRUGMYCOPHENOLATE MOFETIL

DRUGPlacebo

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

DRUGDURVALUMAB

DRUGOncoTICE® powder for instillation fluid for intravesical use containing 2-8 x 108 CFU Tice BCG.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Disease-free survival (DFS)	—

Secondary

Measure	Time frame
Disease free at 24 months (DFS24) Survival at 5 years (OS5) Complete response rate (CRR) Any disease-free survival (aDFS) Time to muscle-invasive bladder (MIBC) cancer ormetastasis Time to cystectomy. Time to development of upper track urothelial carcinoma(UTUC) Disease related symptoms Patient reported treatment tolerability Assessment of PK of Durvalumab Immunogenicity of Durvalumab (ADA) in combination with BCG	—

Measure

Time frame

—

Countries

Austria, Belgium, France, Germany, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026