Clinical trial NCT06810141: ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
Official title: ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: NMIBC
Lead sponsor: ImmunityBio, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-05
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT

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 to receive TICE® BCG, may benefit from its use, and who are ineligible to participate in a clinical trial using rMBCG, or for other reasons cannot participate (eg, geographically unable to access a study site).


Eligibility criteria: Inclusion Criteria:

Participants must meet all of the following criteria for inclusion in the study:

1. Age ≥18 years old.
2. Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology).
3. Ineligible to participate in a clinical trial using rMBCG or geographically unable to access a rMBCG clinical trial site.
4. Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.

Exclusion Criteria:

Participants with any of the following criteria are excluded from participation in the study:

1. Other illness or condition, including laboratory abnormalities, which in the opinion of the Investigator would exclude the participant from participating in this study. This includes, but is not limited to, serious medical conditions or psychiatric illness likely to interfere with participation in the study.
2. Women who are pregnant or nursing. Female participants of childbearing potential must have a negative pregnancy test and must adhere to using a medically acceptable method of birth control prior to screening and agree to continue its use during the study and for 30 days after the last dose of study drug, or be surgically sterilized (eg, hysterectomy or tubal ligation). Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Males must agree to use barrier methods of birth control while on study and for 90 days post last dose of study drug.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University Urology
state: Alabama
city: Mobile
country: United States
facility: Urology Associates
state: Alabama
city: Fort Myers
country: United States
facility: Genesis Care
state: Florida
city: Lake Worth
country: United States
facility: Cohen Urology
state: Florida
city: Sebring
country: United States
facility: Sebring Urology Center
state: Florida
city: Tampa
country: United States
facility: Florida Urology Partners
state: Florida
city: Albany
country: United States
facility: Albany Urology Clinic and Surgery Center
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Skokie
country: United States
facility: Advanced Urology Skokie
state: Illinois
city: Carmel
country: United States
facility: Urology of Indiana
state: Indiana
city: Jeffersonville
country: United States
facility: First Urology, P.S.C
state: Indiana
city: Lenexa
country: United States
facility: Kansas City Urology Care, PA
state: Kansas
city: Natchitoches
country: United States
facility: NRMC Urology Associates
state: Louisiana
city: Shreveport
country: United States
facility: Willis Knighton Urologic Oncology at Pierremont
state: Louisiana
city: Springfield
country: United States
facility: Pioneer Valley Urology, P.C.
state: Massachusetts
city: Waterford
country: United States
facility: Comprehensive Urology
state: Michigan
city: Lincoln
country: United States
facility: Cancer Partners of Nebraska
state: Nebraska
city: Hamilton
country: United States
facility: University Urology of NJ
state: New Jersey
city: Manasquan
country: United States
facility: Advance Urology Associates Enterprises/ HLP Urology Associates
state: New Jersey
city: Garfield Heights
country: United States
facility: Cleveland Clinic
state: Ohio
city: Wyomissing
country: United States
facility: Center for Urologic Care of Berks County
state: Pennsylvania
city: El Paso
country: United States
facility: Rio Grande Urology
state: Texas
city: Fairfax
country: United States
facility: Potomac Urology
state: Virginia
Study officials:
References: