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

Bladder Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111235
• Other study ID #: PIVOT-006
• Status: Recruiting
• Phase: Phase 3
• Start date: December 14, 2023
• Est. completion date: January 2030

Study information

• Verified date: March 2024
• Source: CG Oncology, Inc.
• Contact: Shelly Basye, MD
• Phone: 949-419-6149
• Email: pivot-006[@]CGoncology.com; Recruitment[@]cgoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 426
• Est. completion date: January 2030
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cretostimogene Grenadenorepvec
Engineered Oncolytic Adenovirus

Other:
• n-dodecyl-B-D-maltoside
Transduction-enhancing agent

Locations

Country	Name	City	State
United States	Urology Austin, PLLC	Austin	Texas
United States	Michael G. Oefelein MD Clinical Trials	Bakersfield	California
United States	Chesapeake Urology Associates, LLC	Baltimore	Maryland
United States	Montefiore Medical Center	Bronx	New York
United States	Lakeland Regional Health	Lakeland	Florida
United States	Tower Urology	Los Angeles	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Urology Associates, P.C.	Nashville	Tennessee
United States	University of Pennsylvania - Perelman School of Medicine	Philadelphia	Pennsylvania
United States	Arizona Institute of Urology PLLC	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
CG Oncology, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chang SS, Boorjian SA, Chou R, Clark PE, Daneshmand S, Konety BR, Pruthi R, Quale DZ, Ritch CR, Seigne JD, Skinner EC, Smith ND, McKiernan JM. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. J Urol. 2016 Oct;196(4):1021-9. doi: 10.1016/j.juro.2016.06.049. Epub 2016 Jun 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence Free Survival (RFS)	Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT	51 months
Secondary	Recurrence Free Survival (RFS) at 12 months and 24 months	Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT at 12 months and 24 months	51 months (RFS at 12 months) and 63 months (RFS at 24 months)
Secondary	Incidence of Adverse Events	Safety of cretostimogene following TURBT	52 months

External Links

•   NCCN Guidelines Bladder Cancer 3.2023