LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve
Condition(s) studied
Investigational drug(s) / intervention(s)
EG-70 (phase 1): Patients will receive up to four cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes.One cycle lasts approximately 12 weeks and consists of either a 2-dose (Day 1 and Day 8) or 4-dose (Day 1, Day 8, Day 29 and Day 36) regimen.
EG-70 (phase 2) Master Protocol: Under the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles, of EG-70 at the RP2D defined in Phase 1, administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle lasts approximately 12 weeks. For Maintenance treatment 2 doses of EG-70 will be administered as a bladder instillation per 12-week cycle.
Surfactant Bladder Pre-Rinse and EG-70 (Substudy): Patients will receive via catheter a 50 mL volume of a 5-minute bladder rinse immediately prior to administration of 50 mL of detalimogene voraplasmid (EG-70) at the RP2D for 30 minutes. During the Treatment Period, patients will receive 4 instillations per cycle for up to 4 cycles of the sudy intervention. One cycle lasts approximately 12 weeks. For Maintenance treatment, 2 doses of the study intervention will be administered as a bladder instillation per 12-week cycle.
Study summary
This study will evaluate the safety and efficacy of intravesical administration of detalimogene (EG-70) in the bladder and its effect on bladder tumors in patients with NMIBC.
This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with: NMIBC with CIS for whom BCG therapy is unresponsive, and other high risk patients with NMIBC.
A Substudy will include a surfactant bladder rinse prior to the instillation of detalimogene in patients with NMIBC with CIS for whom BCG therapy is unresponsive.
Eligibility
Primary outcome measure(s)
- Phase 1: Nature, incidence, relatedness, and severity of all AEs and SAEs according to the CTCAE v5.0. — Approximately 2 years
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored. - Phase 2: Percentage of patients with cystoscopic CR at any time, based on exam, urine cytology and appropriate biopsies. — Approximately 24 weeks
Complete response rate will be measured by determining the number of patients without recurrence of disease. - Phase 2: Nature, incidence, relatedness, and severity of treatment emergent adverse events (as assessed by CTCAE v5.0) — Approximately 3 years
The type, incidence, relatedness and severity of treatment emergent adverse events of EG-70 as assessed by NCI-CTCAE V5.0 will be monitored.
Trial sites (102)
| Facility | City | Region | Status |
|---|---|---|---|
| The University of Alabama at Birmingham Clinical Research Unit (CRU) | Birmingham | Alabama | Recruiting |
| Mayo Clinic | Scottsdale | Arizona | Recruiting |
| Urological Associates of South Arizona | Tucson | Arizona | Completed |
| Arkansas Urology | Little Rock | Arkansas | Recruiting |
| University of California - Irvine Medical Center | Irvine | California | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Tower Urology | Los Angeles | California | Recruiting |
| Om Research | San Diego | California | Recruiting |
| Colorado Clinical Research | Lakewood | Colorado | Recruiting |
| The George Washington Medical Faculty Associates | Washington D.C. | District of Columbia | Recruiting |
| University of Florida | Jacksonville | Florida | Recruiting |
| Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics | Miami | Florida | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | Recruiting |
| Urology of Indiana | Greenwood | Indiana | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| John Hopkins Hospital | Baltimore | Maryland | Recruiting |
| Chesapeake Urology Research Associates | Hanover | Maryland | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | Recruiting |
| Henry Ford Health System | Detroit | Michigan | Recruiting |
| Corewell Health Medical Group and Spectrum Health Hospitals | Grand Rapids | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Mayo Clinic | Rochester | Minnesota | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | Recruiting |
| New Jersey Urology, LLC | Voorhees Township | New Jersey | Recruiting |
| Albany Medical College | Albany | New York | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | Recruiting |
| Mount Sinai Medical Center | New Haven | New York | Recruiting |
| Laura & Isaac Perlmutter Cancer Center at NYU Langone Health | New York | New York | Completed |
| Associated Medical Professionals of NY, | Syracuse | New York | Recruiting |
| UNC Chapel Hill Hospital | Chapel Hill | North Carolina | Recruiting |
| Duke Health - Duke Cancer Center | Durham | North Carolina | Recruiting |
| Associated Urologists of North Carolina | Raleigh | North Carolina | Recruiting |
| University of Cincinnati Medical Center | Cincinnati | Ohio | Recruiting |
| Central Ohio Urology Group | Gahanna | Ohio | Recruiting |
| Clinical Research Solutions - Helios Clinical Research | Middleburg Heights | Ohio | Recruiting |
| Oregon Health & Science University (OHSU) | Portland | Oregon | Recruiting |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania | Recruiting |
| Carolina Urologic Research Center, LLC | Myrtle Beach | South Carolina | Recruiting |
+ 62 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04752722 on ClinicalTrials.gov ↗ ← All trials in Italy