Official Title
ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
Brief Summary

This expanded access protocol is designed to provide Recombinant Mycobacterium BCG(rMBCG) to patients with Non-muscle invasive bladder cancer (NMIBC) who are eligible toreceive TICE® BCG, may benefit from its use, and who are ineligible to participate in aclinical trial using rMBCG, or for other reasons cannot participate (eg, geographicallyunable to access a study site).

Detailed Description

Not Provided

Available
Treatment IND/Protocol
NMIBC

Biological: rMBCG

1-19.2e8 colony-forming units (CFU) of rMBCG

Eligibility Criteria

Participant Eligibility:

Women and men of all races and ethnic groups are eligible for this trial.

Inclusion Criteria and Contraindications:

Participants must meet the inclusion criteria and contraindications determined by the
standards of their institution per the TICE BCG label. In BCG naïve subjects with NMIBC,
enrollment should occur only if TICE BCG is unavailable.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 100 Years
Countries
United States
Locations

Urology Centers of Alabama
Homewood, Alabama, United States

University Urology
Mobile, Alabama, United States

Urology Associates
Mobile, Alabama, United States

Mayo Clinic
Phoenix, Arizona, United States

Center for Neurosciences
Tucson, Arizona, United States

UC San Diego Moores Cancer Center
La Jolla, California, United States

USC/ Norris Comprehensive Cancer Center
Los Angeles, California, United States

Urology Center of Southern California
Murrieta, California, United States

Saint John's Cancer Institute (Providence)
Santa Monica, California, United States

Advent Health Porter
Denver, Colorado, United States

MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States

Broward Urology Center
Fort Lauderdale, Florida, United States

Genesis Care
Fort Myers, Florida, United States

Mayo Clinic
Jacksonville, Florida, United States

Cohen Urology
Lake Worth, Florida, United States

Sebring Urology Center
Sebring, Florida, United States

Florida Urology Partners
Tampa, Florida, United States

Albany Urology Clinic and Surgery Center
Albany, Georgia, United States

Emory University
Atlanta, Georgia, United States

Georgia Urology
Atlanta, Georgia, United States

Augusta Urology Associates, LLC
Evans, Georgia, United States

Hawaii Cancer Care
Honolulu, Hawaii, United States

Island Urology Oahu
Honolulu, Hawaii, United States

North Idaho Urology, PLLC
Coeur d'Alene, Idaho, United States

The Urology Clinic
Meridian, Idaho, United States

Comprehensive Urologic Care
Lake Barrington, Illinois, United States

Advanced Urology Skokie
Skokie, Illinois, United States

Urology of Indiana
Carmel, Indiana, United States

US Urology Partners - Carmel
Greenwood, Indiana, United States

First Urology, P.S.C
Jeffersonville, Indiana, United States

Kansas City Urology Care, PA
Lenexa, Kansas, United States

Wichita Urology
Wichita, Kansas, United States

Louisiana Healthcare Associates
Covington, Louisiana, United States

NRMC Urology Associates
Natchitoches, Louisiana, United States

Willis Knighton Urologic Oncology at Pierremont
Shreveport, Louisiana, United States

Pioneer Valley Urology, P.C.
Springfield, Massachusetts, United States

Karmanos Cancer Institute
Detroit, Michigan, United States

Comprehensive Urology
Waterford, Michigan, United States

Essentia Health - Duluth Clinic
Duluth, Minnesota, United States

Allina Health Cancer Institute- Abbott Northwestern Hospital
Minneapolis, Minnesota, United States

Minnesota Urology
Woodbury, Minnesota, United States

Cancer Partners of Nebraska
Lincoln, Nebraska, United States

The Urology Center, P. C. D/B/A/ UroHealth Partners
Omaha, Nebraska, United States

University Urology of NJ
Hamilton, New Jersey, United States

Advance Urology Associates Enterprises/ HLP Urology Associates
Manasquan, New Jersey, United States

Garden State Urology
Morristown, New Jersey, United States

Capital Health Urology
Pennington, New Jersey, United States

Albany Medical College
Albany, New York, United States

NYU Langone Health
New York, New York, United States

SUNY Upstate Medical University
Syracuse, New York, United States

Advanced Urology, Center for Robotic Surgery
Leland, North Carolina, United States

Cleveland Clinic
Cleveland, Ohio, United States

Cleveland Clinic
Garfield Heights, Ohio, United States

Department of Urology, Jefferson Einstein Hospital
Philadelphia, Pennsylvania, United States

Center for Urologic Care of Berks County
Wyomissing, Pennsylvania, United States

Urology Associates of Charleston
Mt. Pleasant, South Carolina, United States

AUC Urologists, LLC
Myrtle Beach, South Carolina, United States

Erlanger Health, Inc.
Chattanooga, Tennessee, United States

The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States

The University of Tennessee Medical Center
Knoxville, Tennessee, United States

Rio Grande Urology
El Paso, Texas, United States

The Urology Place
San Antonio, Texas, United States

Danville Urologic Clinic
Danville, Virginia, United States

Potomac Urology
Fairfax, Virginia, United States

Virginia Urology
Richmond, Virginia, United States

Valley Health Urology
Winchester, Virginia, United States

Contacts

Jayson Garmizo
310-912-2230
jayson.garmizo@immunitybio.com

Not Provided

ImmunityBio, Inc.
NCT Number
MeSH Terms
Non-Muscle Invasive Bladder Neoplasms