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

Sponsor

CG Oncology, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06111235

Collaborator

(none)

426

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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-NMIBCThis 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)

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2028

Anticipated Study Completion Date :

Jan 1, 2030

Arms and Interventions

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 Names: CG0070 Other: n-dodecyl-B-D-maltoside Transduction-enhancing agent Other Names: 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.

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 Names:

CG0070

Other: n-dodecyl-B-D-maltoside

Transduction-enhancing agent

Other Names:

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.

Outcome Measures

Primary Outcome Measures

Recurrence Free Survival (RFS) [51 months]
Recurrence free survival (RFS) of cretostimogene after TURBT versus observation after TURBT

Secondary Outcome Measures

Recurrence Free Survival (RFS) at 12 months and 24 months [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
Incidence of Adverse Events [52 months]
Safety of cretostimogene following TURBT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Recurrent LG Ta within 12 months of prior LG or HG (HG Ta ≤ 3 cm) tumor
Solitary LG Ta >3 cm tumor
Multifocal LG Ta tumors
Primary and solitary HG Ta ≤3 cm tumor
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)