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New treatment option for NMIBC
Official title ResQ133A-NMIBC: Intravesical Recombinant Mycobacterium (rMBCG) in Participants With NMIBC Eligible to Receive Intravesical Tice BCG
ClinicalTrials.gov ID: NCT06800963
What this study is testing
What is Intravesical Recombinant Mycobacterium (rMBCG)?
Intravesical Recombinant Mycobacterium (rMBCG) is an investigational medicine, being studied as a potential treatment for nmibc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 1/2, open-label, multicenter study of intravesical Recombinant Mycobacterium Bacillus Calmette-Guérin (BCG) in participants with Non-muscle invasive bladder cancer (NMIBC) who have not received Bacillus Calmette-Guérin and have histologically confirmed presence of Carcinoma in situ (CIS) or have primary or recurrent stage Ta and/or T1 papillary tumors following Transurethral resection.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Participants must meet ALL of the following criteria for inclusion in the study:
- Male or female participants 18 years of age or older.
- Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology...
- Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
You likely can't join if
- Participants with ANY of the following criteria are excluded from participation in the study:
- Life expectancy \<2 years
- Any of the following clinical laboratory values at the time of enrollment:
- Absolute neutrophil count (ANC) \<800/μL
- Platelets \< 50,000/μL
- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) \>...
See the full eligibility criteria
- Participants must meet ALL of the following criteria for inclusion in the study:
- Male or female participants 18 years of age or older.
- Histologic confirmation of BCG naïve non-muscle invasive urothelial carcinoma of the bladder (mixed histology tumors allowed if urothelial histology is predominant histology) AND either i) histologically confirmed...
- Absence of resectable disease after TURBT procedures (residual CIS acceptable; participants with T1 tumors must undergo repeat resection and biopsy [inclusive of muscularis propria] of the T1 tumor site if initial...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Voluntary written informed consent and agreement to comply with all protocol specified procedures and follow-up evaluations.
- Participants with ANY of the following criteria are excluded from participation in the study:
- Life expectancy \<2 years
- Any of the following clinical laboratory values at the time of enrollment:
- Absolute neutrophil count (ANC) \<800/μL
- Platelets \< 50,000/μL
- Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) \> 2 X upper limit of normal (ULN)
- Renal insufficiency as indicated by a creatinine level \>3 X ULN
- History of or evidence of muscle-invasive, locally advanced, metastatic and/or extravesical bladder cancer (inclusive of the prostatic urethra); or any other cancer within the past 5 years that is progressing or...
- Symptomatic congestive heart failure (CHF), New York Heart Association (NYHA) Class III or IV heart failure or other clinical signs of severe cardiac dysfunction.
- Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry.
- History or evidence of uncontrollable central nervous system disease.
- Active systemic infection requiring parenteral antibiotic therapy. All prior infections must have resolved following optimal therapy.
- Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions.
- Ongoing chronic systemic steroid therapy required (\>10 mg oral prednisone daily or equivalent).
- 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...
- Participants currently receiving investigational or commercial anticancer agents or anticancer therapies other than rMBCG and supportive care therapies for active disease.
- Concurrent use of other investigational agents (not including FDA authorized drugs for the prevention and treatment of COVID-19).
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Sacramento, California, United States
- Atlanta, Georgia, United States
- Troy, Michigan, United States
- Syracuse, New York, United States
- Cynwyd, Pennsylvania, United States
- Germantown, Tennessee, United States
- Nashville, Tennessee, United States
- Alexandria, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Sacramento, California, United States; Atlanta, Georgia, United States; Troy, Michigan, United States; Syracuse, New York, United States; Cynwyd, Pennsylvania, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.