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

NCT03719300 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BC-819-18-204
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 48

Brief 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.

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Keywords

BCG-unresponsive

Outcome Measures

Primary Outcomes (1)

• The Percentage of Patients With Baseline CIS That Achieve a Complete Response After Treatment With BC-819 (Measured at 12 Weeks)

  Complete response is defined as at least one of the following: * Negative cystoscopy and negative (including atypical) urine cytology * Positive cystoscopy with biopsy-proven benign or low-grade NMIBC and negative cytology * Negative cystoscopy with malignant urine cytology if cancer is found in the upper tract or prostatic urethra and random bladder biopsies are negative The complete response in patients with CIS for this endpoint was documented on or after the Week 12 response assessment and on or prior to the Week 48 assessment. Duration of complete response in patients with CIS was calculated from the documented onset of the complete response to the assessment where the patient no longer met the definition of complete response.

  12 weeks

Secondary Outcomes (7)

• Percentage of Patients With Absence of High-grade Recurrent or Persistent Disease at 48 Weeks (Overall Population and Subgroup of Patients With CIS)

  48 weeks

• Percentage of Patients With Absence of High-grade Recurrent or Persistent Disease at 12, 24, 36, 72, and 96 Weeks (Overall Population and Subgroup of Patients With CIS)

  12, 24, 36, 72, and 96 weeks

• Percentage of Patients Who Are Progression-free at 48, 72, and 96 Weeks

  48, 72, and 96 weeks

• Overall Survival of Patients Enrolled in the Study at 48, 72, and 96 Weeks

  48, 72, and 96 weeks

• Quality of Life in Patients Treated With BC-819

  48, 72, and 96 weeks

Study Arms (1)

Single Arm BC-819

EXPERIMENTAL

inodiftagene vixteplasmid

Drug: inodiftagene vixteplasmid

Interventions

inodiftagene vixteplasmid DRUG

BC-819 at 20 mg/50 mL, instilled intravesically into the bladder, with a retention time of at least 30 minutes (up to 2 hours). Induction Phase (weekly treatments): 10 weekly treatments; Maintenance Phase: treatment every 3 weeks for up to 84 additional weeks

Also known as: BC-819

Single Arm BC-819

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

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

Sponsors & Collaborators

• Anchiano Therapeutics Israel Ltd.: lead

Study Sites (48)

Alaska Urological Institute

Anchorage, Alaska, 99503, United States

Location

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Urological Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

American Institute of Research

Los Angeles, California, 90017, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

The Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

University of Florida Health Jacksonville, Shands Hospital

Jacksonville, Florida, 33209, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

North Idaho Urology

Coeur d'Alene, Idaho, 83814, United States

Location

Idaho Urologic Institute, PA

Meridian, Idaho, 83642, United States

Location

University of Illinois Hospital and Health Systems (Outpatient Care Center)

Chicago, Illinois, 60612, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70114, United States

Location

Ochsner Clinical Foundation

New Orleans, Louisiana, 70121, United States

Location

Johns Hopkins Medical Institution

Baltimore, Maryland, 21287, United States

Location

Spectrum Health Medical Group

Grand Rapids, Michigan, 49546, United States

Location

Michigan Institute of Urology, PC

Troy, Michigan, 48084, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis University

St Louis, Missouri, 63110, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

New Jersey Urology, LLC

Belleville, New Jersey, 08043, United States

Location

MD Anderson Cancer Center at Cooper

Voorhees Township, New Jersey, 08103, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Weill Cornell Medical College - NY Presbyterian Hospital

New York, New York, 10065, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

UNC Chapel Hill Hospital, Urology Clinic

Chapel Hill, North Carolina, 27514, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Alliance Urology Specialists, PA

Greensboro, North Carolina, 27403, United States

Location

Carolina Urology Partners, PLLC

Huntersville, North Carolina, 28078, United States

Location

University of Toledo, Dept. of Urology and Kidney Transplant

Toledo, Ohio, 43614, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University South Carolina

Charleston, South Carolina, 29425, United States

Location

Regional Urology

Greenville, South Carolina, 29605, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine Medical Center

Houston, Texas, 77030, United States

Location

The Methodist Hospital d/b/a Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Urology

Richmond, Virginia, 23235, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

West Virginia University Cancer Institute

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: David Kerstein, M.D.,Chief Medical Officer
• Organization: Anchiano Therapeutics, Israel Ltd.1 Kendall Square, Building 1400, Suite 105 Cambridge, MA 02139

David.Kerstein@anchiano.com

857-259-4626

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 25, 2018
• Study Start: March 20, 2019
• Primary Completion: November 18, 2019
• Study Completion: December 18, 2019
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Locations

US (48)