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Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure (BOND2)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cold Genesys, Inc.
ClinicalTrials.gov Identifier:
NCT02365818
First received: February 9, 2015
Last updated: August 8, 2017
Last verified: August 2017
  Purpose
To study the safety and efficacy of CG0070, an oncolytic virus expression GMCSF in high grade non muscle invasive bladder cancer patients who failed BCG therapy and refused cystectomy.

Condition Intervention Phase
Bladder Cancer Biological: CG0070 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Arm, Phase II, Multicenter Study of the Safety and Efficacy of CG0070 Oncolytic Vector Regimen in Patients With Non-Muscle Invasive Bladder Carcinoma Who Have Failed BCG Therapy and Refused Cystectomy

Resource links provided by NLM:


Further study details as provided by Cold Genesys, Inc.:

Primary Outcome Measures:
  • Durable Complete Response Proportion (DCR) [ Time Frame: 18 months time point from the date of the first intravesical intervention ]
    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


Secondary Outcome Measures:
  • Cystectomy Free Survival [ Time Frame: 18 months after the first intravesical treatment ]
  • Complete Response Survival [ Time Frame: 18 months after the first intravesical treatment ]
  • Progression Free Survival [ Time Frame: 18 months after the first intravesical treatment ]
  • Time to Progression to Muscle Invasive Disease [ Time Frame: 18 months after the first intravesical treatment ]
  • Overall Survival [ Time Frame: 18 months and 24 months after first intravesical treatment ]
  • PD-L1 Status Changes [ Time Frame: changes between pre-intervention and post intervention at either cystectomy or at biopsy up to 24 months ]
    PD-L1 status of cancer cells and immune cells at tumor site by IHC

  • Organ Confined Disease Proportions [ Time Frame: at cystectomy ]
    Patient proportions with no cancer cells in regional lymph nodes at cystectomy

  • Complete Response Proportions [ Time Frame: 24 months after the first intravesical treatment ]
    Proportions of patients with a complete response of at least 12 months' duration

  • PD-1 Status Changes [ Time Frame: changes between pre-intervention and post intervention at either cystectomy or at biopsy up to 24 months ]
    PD-1 status of immune cells at tumor site by IHC

  • Disease Regression Proportions [ Time Frame: 24 months after the first intravesical treatment ]
    Proportions of patients with a partial response and/or a complete response of less than 12 months' duration


Enrollment: 66
Actual Study Start Date: June 2, 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CG0070
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
Other Name: oncolytic adenovirus with a E2F promotor and expresses GMCSF

Detailed Description:
The plan is to study the safety and efficacy of CG0070 in high-grade NMIBC patients who failed BCG therapy. Most patients with NMIBCis (Cis, Cis with Ta and/or T1, high grade Ta or T1 with frequent or uncontrolled recurrences) who have failed BCG intravesical therapy (standard of care) usually have no other choice but to proceed to cystectomy. Cystectomy is a surgery associated with major morbidity, mortality and quality of life issues. Morbidity and long term tedious medical care will be for the rest of the patient's life span. Most patients at this stage do not show signs of disease progression into the muscle layer or of metastasis, making surgery a very difficult decision. CG0070, if successful in this trial, will serve to provide a therapeutic alternative for this patient population in need.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must have pathologically confirmed non-muscle invasive bladder cancer (NMIBC) high grade disease (HG), as defined by the 2004 WHO classification system
  2. Patients must have no evidence of muscle invasive disease
  3. 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.
  4. Patients must have received at least two or more prior courses of intravesical therapy per recommended schedules. BCG must have been one of the prior therapies administered.
  5. 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.
  6. 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
  7. 18 years of age or older
  8. 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.
  9. 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.
  10. Eastern Cooperative Oncology Group (ECOG) performance status <2.
  11. Not pregnant or lactating
  12. Patients with child bearing potential must agree to use adequate contraception
  13. Agree to study specific informed consent and HIPAA authorization for release of personal health information
  14. Adequate baseline CBC, renal and hepatic function. Parameters described as WBC>3000 cells/mm^3, ANC>1,000 cells/mm^3, hemoglobin>9.5g/dL, and platelet count >100,000 cells/mm^3

    • Adequate renal function: serum creatinine <2.5mg/dL
    • Bilirubin, AST and ALT not more than 2 x Upper Limits of Normal
    • PT/INR, PTT, and fibrinogen within institutional acceptable limits
    • Absolute lymphocyte count ≥ 800/μL before the first dose of CG0070

Exclusion Criteria:

  1. Previous systemic chemotherapy or radiation for bladder cancer. Note: Prior immunotherapy or intravesical (administered within the bladder) chemotherapy for superficial disease is acceptable
  2. 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.
  3. Known infection with HIV, HBV or HCV.
  4. Anticipated use of chemotherapy or radiotherapy not specified in the study protocol while on study
  5. 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.
  6. Systemic treatment on any investigational clinical trial within 28 days prior to registration.
  7. 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.
  8. Immunosuppressive therapy, including: cyclosporine, antithymocyte globulin, or tacrolimus within 3 months of study entry.
  9. History of prior experimental cancer vaccine treatment (e.g., dendritic cell therapy, heat shock vaccine) within the last year
  10. 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.
  11. 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
  12. Unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02365818

Locations
United States, Alaska
Alaska Clinical Research Center
Anchorage, Alaska, United States, 99503
United States, Arizona
BCG Oncology
Phoenix, Arizona, United States, 85032
Arizona Institute of Urology
Tucson, Arizona, United States, 85704
United States, California
Institute of Urologic Oncology at UCLA
Los Angeles, California, United States, 90095
UC Irvine Medical Center
Orange, California, United States, 92868
University of California, San Diego
San Diego, California, United States, 92093
United States, Florida
UF Health Cancer Center
Gainesville, Florida, United States, 32610
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Michigan
Michigan Institute of Urology, P.C.
Troy, Michigan, United States, 48084
United States, Nebraska
Adult Pediatric Urology and Urogynecology, PC
Omaha, Nebraska, United States, 68114
GU Research Network/ The Urology Center
Omaha, Nebraska, United States, 68130
United States, New Jersey
Premier Urology Group, LLC.
Edison, New Jersey, United States, 08837
United States, New York
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States, 12061
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
The Urology Group
Cincinnati, Ohio, United States, 45212
United States, Tennessee
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Cold Genesys, Inc.
Investigators
Principal Investigator: Gary Steinberg, MD University of Chicago
  More Information

Responsible Party: Cold Genesys, Inc.
ClinicalTrials.gov Identifier: NCT02365818     History of Changes
Other Study ID Numbers: BOND 2 version 3.8
Study First Received: February 9, 2015
Last Updated: August 8, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cold Genesys, Inc.:
Bladder Cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 21, 2017