NCT03335059 (RITE-USA) is a Phase 3 clinical trial of Synergo® RITE + MMC in Bladder Cancer, sponsored by Medical Enterprises Ltd..

Who is sponsoring NCT03335059?

NCT03335059 is sponsored by Medical Enterprises Ltd..

What drugs are being tested in NCT03335059?

Interventions in NCT03335059: Synergo® RITE + MMC.

What condition does NCT03335059 study?

NCT03335059 studies Bladder Cancer, Bladder Neoplasm, Bladder Tumors, Cancer of Bladder, Cancer of the Bladder, Malignant Tumor of Urinary Bladder, Neoplasms, Bladder, Urinary Bladder Cancer, Carcinoma in Situ of Bladder, Papillary Carcinoma of Bladder (Diagnosis), BCG-Unresponsive Bladder Cancer.

Is NCT03335059 still recruiting?

NCT03335059 is currently terminated. Last updated 15 April 2020.

Last reviewed 2020-04-15 · How we verify

NCT03335059: RITE-USA

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

Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors.

Terminated Phase 3 Last updated 15 April 2020

What this trial tests

Phase 3 trial testing Synergo® RITE + MMC in Bladder Cancer in 5 participants. Terminated before completion.

Timeline

4 April 2019

Primary endpoint
26 February 2020

26 February 2020

Quick facts

Lead sponsor	Medical Enterprises Ltd.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	4 April 2019
Primary completion	26 February 2020
Estimated completion	26 February 2020
Sites	4 locations across United States

Drugs / interventions tested

Synergo® RITE + MMC

Conditions studied

Bladder Cancer — all drugs for Bladder Cancer →
Bladder Neoplasm — all drugs for Bladder Neoplasm →
Bladder Tumors — all drugs for Bladder Tumors →
Cancer of Bladder — all drugs for Cancer of Bladder →

Sponsor

Medical Enterprises Ltd.

Who can join

18 and older, any sex, with Bladder Cancer or Bladder Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will determine whether Synergo® RITE + MMC treatment is efficacious as second-line therapy for CIS NMIBC BCG-unresponsive patients with or without papillary NMIBC, through examination of the complete response rate (CRR) and disease-free duration for complete responders. The study will also explore progression-free survival time, bladder preservation rate, and overall survival time. The study will address an unmet need to identify a treatment effective in both ablating the disease and providing a prolonged disease-free period for patients. Ideally, the treatment will delay progression to invasive disease, thus preserving the bladder.

Publications & conference data

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

Intravesical Radiofrequency-Induced Chemohyperthermia for Carcinoma <i>in Situ</i> of the Urinary Bladder: A Retrospective Multicentre Study.
van Valenberg FJP, Kajtazovic A, Canepa G, Lüdecke G, et al · · 2018 · cited 16× · PMID 30417047 · DOI 10.3233/blc-180187
Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer.
Huang X, Wang X, He Z, Huang Y, et al · · 2025 · cited 1× · PMID 40948378 · DOI 10.1002/cam4.71243

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

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 NCT03335059 (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 Medical Enterprises Ltd.
Last refreshed: 15 April 2020

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/NCT03335059.

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