News
DONATE

Support Line: 833-275-4222

Walk to End Bladder Cancer

Back to Clinical Trials

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

Back to Clinical Trials

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 treatment of Non-Muscle Invasive Bladder Cancer.

View the PIVOT-006 website or download this document for more information about this trial. Or for a listing of questions to ask your doctor, click here.

Learn more about the trial by watching this video:

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 surveillance for the treatment of participants with IR-NMIBC.

DETAILED DESCRIPTION

Participants will be randomized 1:1 to cretostimogene grenadenorepvec after TURBT (Arm A) vs surveillance 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, 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. CT Urogram/MRU every 12 months.

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

  • Overall Status
    Active, not recruiting
  • Start Date
    December 14, 2023
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Recurrence Free Survival (RFS)

Primary Outcome 1 - Timeframe: 29 months

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 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 90 days 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., Adstiladrin)

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Max Kates, MD

Role: Principal Investigator

Affiliation: Johns Hopkins University

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

Related Stories