A Phase III, 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)

Study Identifier:
PIVOT-006
CT.gov Identifier:
NCT06111235
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study 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.

IR-NMIBC, as defined by American Urologic Association-Society of Urologic Oncology Guidelines on NMIBC, is either a Low Grade (LG) stage Ta tumor that recurs within 12 months of prior LG or High Grade (HG) bladder cancer, a solitary LGTa tumor >3cm in size, multifocal LGTa tumors, primary HGTa lesion < 3cm in size, or a LGT1 tumor.

to assess the efficacy and safety of intravesical Cretostimogene after TURBT versus TURBT alone.

Primary disease assessments include serial cystoscopy, urine cytology, axial imaging, and centralized review of pathologic samples.

To compare adjuvant intravesical cretostimogene grenadenorepvec to surveillance after bladder tumor removal.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bladder
  • Urogenital
  • Urinary tract
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    III
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Cretostimogene after TURBT
    • Read More
  • Drug: Other Names:
  • Drug: Participants who recur with IR-NMIBC after TURBT and surveillance will be offered treatment with cretostimogene as per the treatment schedule in Arm A. This arm will be called the Extension Arm.
  • Drug: All participants undergo standard tumor removal, then are randomized to either receive cretostimogene instillations (weekly for 6 weeks, then weekly for 3 weeks every 3 months for one year) or surveillance. Control patients may switch to treatment if they relapse.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • - Pathologically confirmed IR-NMIBC, per American Urologic Association/Society of
    • Urologic Oncology/National Comprehensive Cancer Network guidelines, within 90 days 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
    • Eligibility criteria: age ≥18 years, Eastern Cooperative Oncology Group performance status of 0-2, histologically confirmed IR-NMIBC with absence of nodal or metastatic disease at screening.
    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)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Carolinas
    Myrtle Beach, SC, United States, 29572
    Investigator
    Neal Shore
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Bladder
    Urogenital
    Urinary tract