Efficacy and Safety Evaluation of EN3348 (Mycobacterial Cell Wall-DNA Complex [MCC]) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent/Refractory Non-muscle Invasive Bladder Cancer (EMBARC-RF)
A Phase 3, Randomized, Active-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of EN3348 (MCC) as Compared With Mitomycin C in the Intravesical Treatment of Subjects With BCG Recurrent or Refractory Non-Muscle Invasive Bladder Cancer
Sponsor: Bioniche Life Sciences Inc.
Terminated
Lack of Recruitment
Listed as NCT01200992, this PHASE3 trial focuses on Bladder Neoplasm and Carcinoma in Situ and remains terminated or withdrawn. Sponsored by Bioniche Life Sciences Inc., it has been updated 8 times since 2010, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Status Flow
Change History
8 versions recorded-
Sep 2025 — Present [monthly]
Terminated PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Terminated PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Terminated PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Terminated PHASE3
▶ Show 3 earlier versions
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Sep 2017 — Jun 2018 [monthly]
Terminated PHASE3
-
Feb 2017 — Sep 2017 [monthly]
Terminated PHASE3
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Jan 2017 — Feb 2017 [monthly]
Terminated PHASE3
First recorded
Nov 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Bioniche Life Sciences Inc.
For direct contact, visit the study record on ClinicalTrials.gov .