Codex: Study of Inodiftagene Vixteplasmid (BC-819) in Unresponsive NMIBC

Stopped early · Phase 2

Conditions studied: Non-muscle Invasive Bladder Cancer (NMIBC)

In brief

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.

Key facts

Study ID

NCT03719300

Run by

Anchiano Therapeutics Israel Ltd.

People needed

32

Starts

2019-03-20

Expected to finish

2019-12-18

Last updated by the study team

2020-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Alaska Urological Institute — Anchorage, Alaska, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Mayo Clinic Arizona — Phoenix, Arizona, United States
• Urological Associates of Southern Arizona — Tucson, Arizona, United States
• Arkansas Urology — Little Rock, Arkansas, United States
• American Institute of Research — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• The Urology Center of Colorado — Denver, Colorado, United States
• Mayo Clinic Florida — Jacksonville, Florida, United States
• University of Florida Health Jacksonville, Shands Hospital — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Idaho Urologic Institute, PA — Meridian, Idaho, United States
• University of Illinois Hospital and Health Systems (Outpatient Care Center) — Chicago, Illinois, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• Wichita Urology Group — Wichita, Kansas, United States
• Tulane University School of Medicine — New Orleans, Louisiana, United States
• Ochsner Clinical Foundation — New Orleans, Louisiana, United States
• Johns Hopkins Medical Institution — Baltimore, Maryland, United States
• Spectrum Health Medical Group — Grand Rapids, Michigan, United States
• Michigan Institute of Urology, PC — Troy, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Louis University — St Louis, Missouri, United States
• Washington University — St Louis, Missouri, United States
• New Jersey Urology, LLC — Belleville, New Jersey, United States

Full record on ClinicalTrials.gov

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