NCT03982797 is a Phase 2 clinical trial of Instillation of IMUNO BCG Moreau RJ in Bladder Cancer, sponsored by Biofabri, S.L.

Who is sponsoring NCT03982797?

NCT03982797 is sponsored by Biofabri, S.L.

What drugs are being tested in NCT03982797?

Interventions in NCT03982797: Instillation of IMUNO BCG Moreau RJ.

What condition does NCT03982797 study?

NCT03982797 studies Bladder Cancer.

Is NCT03982797 still recruiting?

NCT03982797 is currently status unknown. Last updated 12 June 2019.

Last reviewed 2019-06-12 · How we verify

NCT03982797

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

Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis

Status unknown Phase 2 Last updated 12 June 2019

What this trial tests

Phase 2 trial testing Instillation of IMUNO BCG Moreau RJ in Bladder Cancer in 306 participants. Status unknown.

Timeline

17 May 2019

Primary endpoint
3 April 2021

3 March 2022

Quick facts

Lead sponsor	Biofabri, S.L
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	306
Start date	17 May 2019
Primary completion	3 April 2021
Estimated completion	3 March 2022
Sites	15 locations across Spain

Drugs / interventions tested

Instillation of IMUNO BCG Moreau RJ — full drug profile →

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Biofabri, S.L — full company profile →

Who can join

Adults 18 to 80, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG \*Bacile Calmette-Guérin" as immunotherapy drug. BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient. Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.

Publications & conference data

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

Pharmacologic Therapies for Non-Muscle Invasive Bladder Cancer: Current and Future Treatments.
Goldberg IP, Lichtbroun B, Singer EA, Ghodoussipour S. · · 2022 · cited 13× · PMID 36051251 · DOI 10.33696/pharmacol.4.030
Nadofaragene firadenovec: a breakthrough in the field of bladder oncology.
Nadeem A, Qamar K, Bilal W, Vohra LI, et al · · 2023 · PMID 40778028 · DOI 10.3389/fruro.2023.1206398
Ataulpho de Paiva Foundation on the stage of BCG.
Castello-Branco LRR. · · 2021 · PMID 33620994 · DOI 10.1590/s1677-5538.ibju.2021.03.02

Verify or expand the search:

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

NCT07419295 — A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031) · Phase 3 · recruiting
NCT07322263 — Intravesical GEM/DOCE for HR BCG-Unresponsive NMIBC · Phase 2 · recruiting
NCT07420517 — Dutasteride in Patients With Low Grade Non-muscle Invasive Bladder Cancer · Phase 2 · recruiting
NCT07475403 — Urinary Tumor DNA-Guided Systemic Immunotherapy for Unresectable Very-High-Risk Non-Muscle-Invasive Bladder Cancer · Phase 2 · recruiting
NCT07277413 — A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors · Phase 1 · recruiting

Other Biofabri, S.L trials

Trials by the same sponsor.

NCT03536117 — Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates · Phase 2 · completed

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 NCT03982797 (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 Biofabri, S.L
Last refreshed: 12 June 2019

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/NCT03982797.

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