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A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06111235
Recruitment Status : Recruiting
First Posted : November 1, 2023
Last Update Posted : March 6, 2024
Sponsor:
Information provided by (Responsible Party):
CG Oncology, Inc.

Brief Summary:
This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by cretostimogene grenadenorepvec versus TURBT followed by observation for the treatment of participants with IR-NMIBC.

Condition or disease Intervention/treatment Phase
Non Muscle Invasive Bladder Cancer Urologic Cancer Bladder Cancer Urothelial Carcinoma Drug: Cretostimogene Grenadenorepvec Other: n-dodecyl-B-D-maltoside Phase 3

Detailed Description:

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs observation after TURBT (Arm B).

Participants in Arm A will receive an induction course and then quarterly maintenance courses of cretostimogene through Month 13, if there is no disease recurrence.

Disease status will be assessed using urine cytology, complete bladder visualization (e.g., cystoscopy), and directed TURBT/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence.

Participants in Arm B who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by adjuvant cretostimogene versus TURBT alone for the treatment of participants with IR-NMIBC
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec Versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Actual Study Start Date : December 14, 2023
Estimated Primary Completion Date : January 2028
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cretostimogene after TURBT
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Drug: Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus
Other Name: CG0070

Other: n-dodecyl-B-D-maltoside
Transduction-enhancing agent
Other Name: DDM

No Intervention: Observation after TURBT

Following screening confirmation of IR-NMIBC and complete resection of tumor, participants will enter observation.

Participants who recur with IR-NMIBC after TURBT and observation will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.




Primary Outcome Measures :
  1. Recurrence Free Survival (RFS) [ Time Frame: 51 months ]
    Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT


Secondary Outcome Measures :
  1. Recurrence Free Survival (RFS) at 12 months and 24 months [ Time Frame: 51 months (RFS at 12 months) and 63 months (RFS at 24 months) ]
    Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT at 12 months and 24 months

  2. Incidence of Adverse Events [ Time Frame: 52 months ]
    Safety of cretostimogene following TURBT



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of Urologic Oncology/National Comprehensive Cancer Network guidelines, within 12 weeks of participant randomization:

    1. Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
    2. Solitary LG Ta >3 cm tumor
    3. Multifocal LG Ta tumors
    4. Primary and solitary HG Ta ≤3 cm tumor
    5. LG T1 tumor
  • All visible disease removed by TURBT within 12 weeks of study randomization
  • Acceptable baseline organ function

Exclusion Criteria:

  • High-risk NMIBC (e.g., HG T1, Recurrent or multifocal HG Ta>3cm tumor(s), CIS)
  • Low-Risk NMIBC (e.g., solitary LG Ta ≤3 cm tumor)
  • Disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization
  • Muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer
  • Prior treatment with any human adenovirus serotype 5 based therapy (e.g., Ad-interferon or Adstiladrin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06111235


Contacts
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Contact: Shelly Basye, MD 949-419-6149 pivot-006@CGoncology.com; Recruitment@cgoncology.com
Contact: Andy Darilek, MD 949-419-6149 pivot-006@CGoncology.com; Recruitment@cgoncology.com

Locations
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United States, Arizona
Arizona Institute of Urology PLLC Not yet recruiting
Tucson, Arizona, United States, 85745
Contact: Andrea Navarrette         
Principal Investigator: Kalpesh Patel, MD         
United States, California
Michael G. Oefelein MD Clinical Trials Recruiting
Bakersfield, California, United States, 93301-2284
Contact: Evelyn De La Cruz         
Principal Investigator: Michael Oefelein, MD         
Tower Urology Recruiting
Los Angeles, California, United States, 90048
Contact: Shiblee Nomanee         
Principal Investigator: David Josephson, MD         
United States, Florida
Lakeland Regional Health Not yet recruiting
Lakeland, Florida, United States, 33805
Contact: Maczko Bridget         
Principal Investigator: Peter Hinds, MD         
United States, Maryland
Chesapeake Urology Associates, LLC Recruiting
Baltimore, Maryland, United States, 21204
Contact: Katie Wright         
Principal Investigator: Rian Dickstein, MD         
United States, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Contact: Andrea Asencio         
Principal Investigator: Alexander Sankin, MD         
United States, Pennsylvania
University of Pennsylvania - Perelman School of Medicine Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dylan Kolman         
Principal Investigator: Trinity Bivalacqua, MD         
United States, South Carolina
Carolina Urologic Research Center Recruiting
Myrtle Beach, South Carolina, United States, 29572
Contact: Jessica Richardson         
Principal Investigator: Neal Shore, MD         
United States, Tennessee
Urology Associates, P.C. Recruiting
Nashville, Tennessee, United States, 37209
Contact: Joe Wallace         
Principal Investigator: Gautam Jayram, MD         
United States, Texas
Urology Austin, PLLC Not yet recruiting
Austin, Texas, United States, 78745
Contact: Cecilia Moreno         
Principal Investigator: Brian Mazzarella, MD         
Sponsors and Collaborators
CG Oncology, Inc.
Investigators
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Principal Investigator: Robert Svatek, MD University of Texas Health Science Center, San Antonio
Additional Information:
Publications:
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Responsible Party: CG Oncology, Inc.
ClinicalTrials.gov Identifier: NCT06111235    
Other Study ID Numbers: PIVOT-006
First Posted: November 1, 2023    Key Record Dates
Last Update Posted: March 6, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CG Oncology, Inc.:
Urology
Bladder Cancer
Non Muscle Invasive Bladder Cancer
Intermediate Risk Non Muscle Invasive Bladder Cancer
Cretostimogene Grenadenorepvec
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
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
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type