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Brief Title: Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

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)

INTRODUCTION

  • Org Study ID: PIVOT-006
  • Secondary ID: N/A
  • NCT ID: NCT06111235
  • Sponsor: CG Oncology, Inc.

DESCRIPTION

The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for the cancer to return. Cretostimogene is an experimental drug and not all risks are known. It is being studied to determine whether it is effective and safe in the the treatment of Non-Muscle Invasive Bladder Cancer.

View the patient information page about this trial. Or for a listing of questions to ask your doctor about this trial, click here. 

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.

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.

  • Overall Status
    Recruiting
  • Start Date
    December 14, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Non Muscle Invasive Bladder Cancer
  • Urologic Cancer
  • Bladder Cancer
  • Urothelial Carcinoma

ELIGIBILITY

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)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Robert Svatek, MD

Role: Principal Investigator

Affiliation: University of Texas Health Science Center, San Antonio

Overall Contact

Name: Shelly Basye, MD, Andy Darilek, MD

Phone: 949-419-6149, 949-419-6149

Email: pivot-006@CGoncology.com; Recruitment@cgoncology.com, pivot-006@CGoncology.com; Recruitment@cgoncology.com

LOCATION

Facility Status Contact
Facility: Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Jessica Richardson

Principal Investigator
Neal Shore, MD