Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

NCT02365818 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BOND 2 version 3.8
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 17

Brief Summary

To study the safety and efficacy of CG0070, an oncolytic virus expression GM-CSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

Conditions

Bladder Cancer

Keywords

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• Durable Complete Response Proportion (DCR)

  Defined as the proportion of patients who experience a durable complete response lasting 12 months or longer from the initial confirmed complete response date (first CR assessment to be at least 6 months after the first intravesical intervention) and at least 18 months from the date of the first intravesical intervention

  18 months time point from the date of the first intravesical intervention

Secondary Outcomes (10)

• Cystectomy Free Survival

  18 months after the first intravesical treatment

• Complete Response Survival

  18 months after the first intravesical treatment

• Progression Free Survival

  18 months after the first intravesical treatment

• Time to Progression to Muscle Invasive Disease

  18 months after the first intravesical treatment

• Overall Survival

  18 months and 24 months after first intravesical treatment

Study Arms (1)

CG0070

EXPERIMENTAL

Single arm intervention with CG0070 to be given at a dose of 1e12 vp weekly for six weeks. Patients who achieve a partial response or a complete response at 6 months post first intravesical intervention will be maintained with the same induction cycle of weekly times six. Patients will be followed every 3 months through Month 24.

Biological: CG0070

Interventions

CG0070 BIOLOGICAL

Also known as: oncolytic adenovirus with a E2F promotor and expresses GMCSF

CG0070

Eligibility Criteria

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

You may qualify if:

• Patients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification system
• Patients must have no evidence of muscle invasive disease
• Patients must be able to provide a sufficient biopsy sample to the central pathologist for histopathologically confirmed, transitional cell (urothelial) carcinoma. Urothelial tumors with mixed histology (but with \<50% variant) are eligible.
• Patients must have received at least two or more prior courses of intravesical therapy per recommended schedules. Bacillus Calmette-Guerin (BCG) must have been one of the prior therapies administered.
• Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The first standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is 4-9). The second course of BCG therapy must include at least two weekly treatments.
• Patients have either Cis or Cis with Ta and/or T1 disease at enrollment or in the past. For those patients with only Ta or T1 disease at enrollment AND with no history of Cis, they must have
• disease recurrence either must occur within 12 months of the most recent intravesical therapy of any kind, OR
• disease recurrence within 18 months of BCG maintenance OR
• disease recurrence within 24 months of BCG induction
• T1 patients need to have evidence of muscle included in their latest biopsy; and if not a re-TURBT has to be done prior to enrollment
• years of age or older
• Radical cystectomy has been declined by the patient in a signed special section of the informed consent, whereby there is a clear explanation by the investigator to the subject that a delay of cystectomy may increase his/her chance of disease progression, the results of which may lead to serious and life threatening consequences.
• Patients must be able to enter into the study within ten weeks of their most recent diagnostic procedure, which is usually a diagnostic biopsy, a transurethral resection of bladder tumor (TURBT) procedure or positive urine cytology.
• Eastern Cooperative Oncology Group (ECOG) performance status \<2.
• Not pregnant or lactating

You may not qualify if:

• Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
• History of anaphylactic reaction following exposure to humanized or human therapeutic monoclonal antibodies, hypersensitivity to GM-CSF or yeast derived products, clinically meaningful allergic reactions or any known hypersensitivity or prior reaction to any of the formulation excipients in the study drugs.
• Known infection with HIV, HBV or HCV.
• Anticipated use of chemotherapy or radiotherapy not specified in the study protocol while on study
• Any underlying medical condition that, in the Investigator's opinion, will make the administration of study vector hazardous to the patient, would obscure the interpretation of adverse events, or not permit adequate surgical resection.
• Systemic treatment on any investigational clinical trial within 28 days prior to registration.
• Concurrent treatment with immunosuppressive or immunomodulatory agents, including any systemic steroid (exception: inhaled or topically applied steroids, and acute and chronic standard dose NSAIDs, are permitted). Use of a short course (i.e., ≤ 1 day) of a glucocorticoid is acceptable to prevent a reaction to the IV contrast used for CT scans.
• Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
• History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) within the last year
• History of stage III or greater cancer, excluding urothelial cancer. Basal or squamous cell skin cancers must have been adequately treated and the subject must be disease-free at the time of registration. Subjects with a history of stage I or II cancer, must have been adequately treated and have been disease-free for ≥ 2 years at the time of registration.
• Progressive or persistent viral or bacterial infection
• All infections must be resolved and the patient must remain afebrile for seven days without antibiotics prior to being placed on study
• Urinary tract infection, including particularly bladder infection, must be resolved prior to being placed on study
• Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel

Sponsors & Collaborators

• CG Oncology, Inc.: lead

Study Sites (17)

Alaska Clinical Research Center

Anchorage, Alaska, 99503, United States

Location

BCG Oncology

Phoenix, Arizona, 85032, United States

Location

Arizona Institute of Urology

Tucson, Arizona, 85704, United States

Location

Institute of Urologic Oncology at UCLA

Los Angeles, California, 90095, United States

Location

UC Irvine Medical Center

Orange, California, 92868, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32610, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Michigan Institute of Urology, P.C.

Troy, Michigan, 48084, United States

Location

Adult Pediatric Urology and Urogynecology, PC

Omaha, Nebraska, 68114, United States

Location

GU Research Network/ The Urology Center

Omaha, Nebraska, 68130, United States

Location

Premier Urology Group, LLC.

Edison, New Jersey, 08837, United States

Location

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12061, United States

Location

Wake Forest University School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Vanderbilt University Medical Center, Dept. of Urologic Surgery

Nashville, Tennessee, 37232, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Gary Steinberg, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

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: February 9, 2015
• First Posted: February 19, 2015
• Study Start: June 2, 2015
• Primary Completion: August 1, 2018
• Study Completion: February 1, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

US (17)