Bladder Cancer Clinical Trial
Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC
Summary
This study, BC-819-18-204, is a Phase 2, open-label, monotherapy, single-arm, multicenter clinical trial of BC-819 (inodiftagene vixteplasmid) in patients with NMIBC adequately treated with Bacillus Calmette-Guerin (BCG) whose disease is BCG unresponsive according to the US Food and Drug Administration (FDA) guidance.
Full Description
BC-819 (inodiftagene vixteplasmid) is a recombinant DNA plasmid that directs the expression of a potent toxin specifically in malignant cells but not in normal tissue. It has been designed to exploit the established biology of the H19 gene, which is upregulated and expressed at high levels only in malignant cells, to produce bacterial diphtheria toxin only in bladder cancer tissue. BC-819 is administered directly into the bladder to enable maximal topical exposure to target bladder cancer cells.
Eligibility Criteria
Inclusion Criteria:
Male or female patients ≥18 years of age at the time of consent
Patient must have been adequately treated with BCG defined as at least one of the following (FDA 2018):
At least five of six doses of an initial induction course plus at least two of three doses of maintenance therapy
At least five of six doses of an initial induction course plus at least two of six doses of a second induction course
A single course of induction BCG can qualify if the patient has T1 high-grade disease at first evaluation (see 3c)
Patient must be BCG-unresponsive defined as at least one of the following (FDA 2018):
Persistent or recurrent CIS alone or with recurrent Ta/T1 disease within 12 months of completion of adequate BCG therapy. An assessment within 15 months can also qualify when no assessment was done 12 months after completion of adequate BCG therapy.
Recurrent high-grade Ta/T1 disease within 6 months of completion of adequate BCG therapy. An assessment within 9 months can also qualify when no assessment was done 6 months after completion of adequate BCG therapy.
T1 high-grade disease at the first evaluation following a single course of induction BCG qualifies (Lerner et al. 2015, Steinberg et al. 2016)
Patient must have, at study entry, NMIBC indicated by 1 or more of the following:
Ta or T1 high-grade disease
CIS disease
Patient must have no known evidence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra within 6 months of enrollment
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
Patient must have adequate hematologic function, as demonstrated by the following:
Hemoglobin level ≥10 g/dL
Absolute neutrophil count ≥1.5 x 109/L
Platelet count ≥100 x 109/L
Patient must have adequate liver and renal function as demonstrated by the following:
Aspartate aminotransferase and alanine aminotransferase each ≤3.0 x upper limit of normal
Total bilirubin ≤1.5 x upper limit of normal, unless prior documentation of Gilbert's syndrome in which case, 3.0 mg/dL is allowed
Serum creatinine ≤1.5 x upper limit of normal or measured or calculated creatinine clearance ≥30 mL/min
Female patients of childbearing potential must use maximally effective birth control during the period of therapy and for 1 month after the last study drug infusion
Male patients who are sexually active must be willing to use a double barrier contraceptive method upon study enrollment, during the course of the study, and for 1 month after the last study drug infusion
Exclusion Criteria:
Patient has current or previous evidence of muscle invasive (muscularis propria) or metastatic bladder cancer disease
Patient has received prior investigational therapy for NMIBC
Patient has received any therapy for NMIBC within 10 weeks before the start of study treatment other than surgical resection, 1 dose of chemotherapy, and previous BCG
Patient is intolerant to previous BCG treatment in the absence of meeting other criteria for BCG unresponsiveness and adequate BCG therapy
Patient has received external beam radiation therapy for bladder cancer at any time or for any other condition
Patient has an active infection, including urinary tract infection (viral, bacterial, or fungal) and cystitis
Patient has urinary tract signs or symptoms that preclude retention of drug in the bladder; this does not include anticholinergic drugs
Patient is known to have tested positive for human immunodeficiency virus (HIV). No HIV testing is required if patient is not known have tested positive
Patient is female and is pregnant or breastfeeding
Patient has a known presence or history of malignancy of other organ system within the 5 years before study start, with the exception of non-melanoma skin cancer; very low or low-risk prostate cancer; or patients who have been disease free for at least 2 years following stage 1 or 2 cancer
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 45 Locations for this study
Anchorage Alaska, 99503, United States
Gilbert Arizona, 85234, United States
Phoenix Arizona, 85054, United States
Tucson Arizona, 85715, United States
Little Rock Arkansas, 72211, United States
Los Angeles California, 90017, United States
Sacramento California, 95817, United States
Denver Colorado, 80211, United States
Jacksonville Florida, 32224, United States
Jacksonville Florida, 33209, United States
Atlanta Georgia, 30322, United States
Coeur d'Alene Idaho, 83814, United States
Meridian Idaho, 83642, United States
Chicago Illinois, 60612, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67226, United States
New Orleans Louisiana, 70114, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21287, United States
Grand Rapids Michigan, 49546, United States
Troy Michigan, 48084, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63110, United States
Belleville New Jersey, 08043, United States
Voorhees New Jersey, 08103, United States
Albany New York, 12208, United States
Bronx New York, 10461, United States
New York New York, 10065, United States
Syracuse New York, 13210, United States
Chapel Hill North Carolina, 27514, United States
Durham North Carolina, 27710, United States
Greensboro North Carolina, 27403, United States
Huntersville North Carolina, 28078, United States
Toledo Ohio, 43614, United States
Oklahoma City Oklahoma, 73104, United States
Bala-Cynwyd Pennsylvania, 19004, United States
Philadelphia Pennsylvania, 19104, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Nashville Tennessee, 37209, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Richmond Virginia, 23235, United States
Virginia Beach Virginia, 23462, United States
Morgantown West Virginia, 26506, United States
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.