Drugs / Bacillus Calmette-Guerin (BCG)

Trials 3

2014201520162017201820192020202120222023202420252026202720282029
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT02326168 Oct 2013 → Oct 2015 urinary bladder cancer The University of Texas Health Science Center at San Antonio Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT03317158 Nov 2017 → Dec 2028 expected urinary bladder cancer, urothelial carcinoma Noah Hahn, M.D. Active not recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT04507126 Mar 2021 → Dec 2022 — Massachusetts General Hospital Completed No outcome recorded
Comparator or background therapy3 trials
Phase 2 NCT02075203 Comparator Feb 2014 → Aug 2017 tuberculosis Aeras Completed Missed primary
Phase 3 NCT04149574 Background Jan 2020 → Oct 2023 urinary bladder neoplasm Bristol-Myers Squibb Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT06767982 Comparator Jan 2019 → Dec 2022 non-invasive bladder urothelial carcinoma Ankara University Completed No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2026-05-28 AstraZeneca Regulatory Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer. astrazeneca.com ↗
AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC).
2026-05-19 ImmunityBio, Inc. Regulatory ImmunityBio Announces FDA Acceptance of Supplemental BLA for ANKTIVA® Plus BCG in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer with Papillary Disease; PDUFA Date Set for January 6, 2027 immunitybio.com ↗
2025-10-17 AstraZeneca Results Imfinzi regimen reduced the risk of disease recurrence or death by 32% in high-risk non-muscle-invasive bladder cancer in the POTOMAC Phase III trial astrazeneca.com ↗
Adding one year of Imfinzi treatment to Bacillus Calmette-Guérin (BCG) induction and maintenance therapy delivered an early and sustained disease-free survival benefit vs. BCG alone
2025-05-09 AstraZeneca Results Imfinzi regimen demonstrated statistically significant and clinically meaningful improvement in disease-free survival for high-risk non-muscle-invasive bladder cancer in POTOMAC Phase III trial astrazeneca.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as Bacillus Calmette-Guerin (BCG) ClinicalTrials.gov intervention name — accepted as the source's own label NCT04507126 ↗
5

NCT02326168 ↗

NCT04149574 ↗

NCT02075203 ↗

NCT06767982 ↗

NCT03317158 ↗

Modality Vaccine “Both the BCG and H4:IC31 vaccines were immunogenic.” PMID 29996082 ↗ Jul 2018
Route Other “intravesical therapy” NCT06767982 ↗