ClinicalTrials.Veeva

Menu
The trial is taking place at:
K

Keystone Urology Specialists | Lancaster, PA

Veeva-enabled site

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

C

CG Oncology

Status and phase

Enrolling
Phase 3

Conditions

Bladder Cancer
Urologic Cancer
Urothelial Carcinoma
Non Muscle Invasive Bladder Cancer

Treatments

Other: n-dodecyl-B-D-maltoside
Drug: Cretostimogene Grenadenorepvec

Study type

Interventional

Funder types

Industry

Identifiers

NCT06111235
PIVOT-006

Details and patient eligibility

About

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.

Full 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.

Enrollment

364 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

364 participants in 2 patient groups

Cretostimogene after TURBT
Experimental group
Description:
Following screening confirmation of IR-NMIBC and complete resection of the tumor, participants will be treated with adjuvant cretostimogene.
Treatment:
Drug: Cretostimogene Grenadenorepvec
Other: n-dodecyl-B-D-maltoside
Observation after TURBT
No Intervention group
Description:
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.

Trial contacts and locations

32

Loading...

Central trial contact

Shelly Basye, MD; Andy Darilek, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems