ResQ132EX-NMIBC: Expanded Access Use of Recombinant Bacillus Calmette-Guérin in Nonmuscle Invasive Bladder Cancer
Purpose
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).
Condition
- NMIBC
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Expanded Access
Recruiting Locations
Homewood 4067927, Alabama 4829764 35209
Mobile 4076598, Alabama 4829764 36606
Mobile 4076598, Alabama 4829764 36607
La Jolla 5363943, California 5332921 92093
Los Angeles 5368361, California 5332921 90033
Murrieta 5375911, California 5332921 92563
Washington D.C. 4140963, District of Columbia 4138106 20010
Fort Lauderdale 4155966, Florida 4155751 33316
954-463-6408
Fort Myers 4155995, Florida 4155751 33908
Lake Worth 4161422, Florida 4155751 33449
Sebring 4172383, Florida 4155751 33870
Tampa 4174757, Florida 4155751 33615
Osvaldo Padron, MD
Albany 4179320, Georgia 4197000 31707
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30328
Evans 4193699, Georgia 4197000 30809
Honolulu 5856195, Hawaii 5855797 96813
Honolulu 5856195, Hawaii 5855797 96813
808-536-2306
Coeur d'Alene 5589173, Idaho 5596512 83814
Meridian 5600685, Idaho 5596512 83642
Skokie 4911600, Illinois 4896861 60077
Carmel 4255466, Indiana 4921868 46032
Greenwood 4258313, Indiana 4921868 46143
Jeffersonville 4259671, Indiana 4921868 47130
Lenexa 4274356, Kansas 4273857 66214
Covington 4321005, Louisiana 4331987 70433
985-892-6811
Natchitoches 4334720, Louisiana 4331987 71457
Shreveport 4341513, Louisiana 4331987 71115
Springfield 4951788, Massachusetts 6254926 01107
Detroit 4990729, Michigan 5001836 48201
Waterford 5014130, Michigan 5001836 48328
Duluth 5024719, Minnesota 5037779 55805
Minneapolis 5037649, Minnesota 5037779 55407
Woodbury 5053358, Minnesota 5037779 55125
Lincoln 5072006, Nebraska 5073708 68156
Omaha 5074472, Nebraska 5073708 68114
Hamilton 5098765, New Jersey 5101760 08690
Manasquan 5100809, New Jersey 5101760 08736
Morristown 5101427, New Jersey 5101760 07960
Pennington 5102535, New Jersey 5101760 08534
Leland 4475622, North Carolina 4482348 28451
Garfield Heights 5155499, Ohio 5165418 44125
Philadelphia 4560349, Pennsylvania 6254927 19141
Wyomissing 5220248, Pennsylvania 6254927 19610
Mt. Pleasant 4588165, South Carolina 4597040 29464
Diane Hader
843-884-8045
Myrtle Beach 4588718, South Carolina 4597040 29572
843-839-1679
Germantown 4624601, Tennessee 4662168 38138
Linda Brantley
901-683-0055
Knoxville 4634946, Tennessee 4662168 37920
El Paso 5520993, Texas 4736286 79912
San Antonio 4726206, Texas 4736286 78240
210-617-3670
Danville 4755280, Virginia 6254928 24541
Fairfax 4758023, Virginia 6254928 22033
Winchester 4794120, Virginia 6254928 22601
More Details
- NCT ID
- NCT06810141
- Status
- Available
- Sponsor
- ImmunityBio, Inc.