2. UroToday Home
  3. Trials in Progress

Trials in Progress

PIVOT-006: A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

Trials in Progress
Videos
Physician-Scientist Review Articles
State of the Evidence Review Articles
Written by Zachary Klaassen, MD, MSc, Wellstar MCG Health Georgia Cancer Center Augusta, Georgia, USA
December 12, 2023

Bladder cancer remains the sixth most commonly diagnosed cancer in the United States, with an estimated 82,290 incident cases in 2023.1 Because of the persistent recurrence risk of NMIBC in a highly comorbid population, there has been an FDA-led drive towards developing novel treatment options for these patients. The following article will highlight recent advances in this disease space with a specific focus on the oncolytic adenovirus agent cretostimogene grenadenorepvec, and the registration trial in intermediate risk non-muscle invasive bladder cancer (NMIBC), PIVOT-006. 

 

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

  • Condition:Bladder Cancer, Urothelial Carcinoma, Urologic Cancer, Non Muscle Invasive Bladder Cancer
  • Study ID: NCT06111235
ACTIVE, NOT RECRUITING
Publications
Articles and Abstracts
  • Rapid enrollment underscores high unmet need in intermediate-risk non-muscle invasive bladder cancer (NMIBC)
  • One of the largest randomized phase 3 studies in this patient population will encompass the broadest range of patient types per AUA/SUO Guidelines
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that it has completed enrollment in its Phase 3, randomized, open-label PIVOT-006 study comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance following bladder tumor removal in patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).
– First Patient Dosed in Expanded Access Program and Enrollment Ongoing –

Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, announced that it has initiated an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) who are unresponsive to Bacillus Calmette-Guerin (BCG) and meet certain program eligibility criteria. The first patient has been dosed in the EAP and enrollment in the study is ongoing.
Cretostimogene grenadenorepvec is a serotype-5 oncolytic adenovirus designed to selectively replicate in cancer cells with retinoblastoma pathway alterations, previously tested as monotherapy in bacillus Calmette–Guérin (BCG)-experienced non-muscle-invasive bladder cancer.
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share. All of the shares are being offered by CG Oncology.
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. announced that Phase 3 monotherapy data from the BOND-003 clinical trial evaluating the efficacy and safety of cretostimogene grenadenorepvec in patients with high-risk NonMuscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), showed that 75.7% of evaluable patients achieved a complete response (CR) at any time, as of the cutoff date of October 5, 2023.
Conference Coverage
Conference Highlights Written by Physician Scientists
Presented by  Siamak Daneshmand, MD
The 2025 Western Section AUA annual meeting featured a urothelial carcinoma session and a presentation by Dr. Siamak Daneshmand discussing PIVOT-006, an ongoing phase 3, randomized study of adjuvant intravesical cretostimogene grenadenorepvec versus surveillance for the treatment of intermediate risk non-muscle invasive bladder cancer.
The 2025 South Central AUA annual meeting included a session on bladder cancer, featuring a trials in progress presentation from Dr. Robert Svatek discussing the PIVOT-006 trial looking at improved therapies for intermediate risk non muscle invasive bladder cancer patients.
Presented by Sia Daneshmand, MD
The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025, was host to the Abstract Session 05: On the Horizon: Ongoing Trials in Urology. Dr. Sia Daneshmand presented A0082: Trial in Progress: PIVOT-006- A Phase 3, Randomized Study of Adjuvant Intravesical Cretostimogene Grenadenorepvec versus Surveillance for the Treatment of Intermediate-Risk Non-Muscle Invasive Bladder Cancer.
Reno, Nevada (UroToday.com) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, announced that a late-breaking abstract on BOND-003 Cohort C, as well as three posters highlighting cretostimogene grenadenorepvec, will be presented at the 40th Annual European Association of Urology (EAU) Congress
Presented by Robert Svatek, MD
The 2024 SUO annual meeting included a urothelial carcinoma session, featuring a presentation by Dr. Robert Svatek discussing PIVOT-006, a phase 3, randomized study of adjuvant intravesical cretostimogene grenadenorepvec versus surveillance for the treatment of intermediate-risk non muscle invasive bladder cancer (NMIBC).
Presented by Robert S. Svatek, MD

Dr. Robert Svatek presented the PIVOT-006 trial, a phase 3, randomized study of cretostimogene grenadenorepvec (CG) versus observation for the treatment of intermediate risk non-muscle invasive bladder cancer (NMIBC) following transurethral resection of bladder tumor (TURBT).

Presented by Joshua J Meeks, MD, PhD
The 2024 GU ASCO annual meeting featured a session on the shortage of drugs for urothelial carcinoma and a presentation by Dr. Josh Meeks discussing what is on the horizon to replace BCG.  Dr. Meeks then discussed the BCG shortage timeline and production challenges. This started in 2012 with the FDA temporarily stopping the Sanofi Pasteur factory due to manufacturing and sterility issues.