Clinical Trial is Now Enrolling

NMIBC continues to be challenging because of frequent disease relapse and patients have limited available treatment options. Patients with Intermediate-Risk NMIBC have been underserved especially since the global BCG shortage. PIVOT-006 is a step in the right direction that aims to address this unmet need and help our patients. I hope that many other Urologists will be interested in this study.”

– Robert Svatek , M.D., MSCI UT Health San Antonio
  Lead Investigator

This video has been sponsored by CG Oncology.

What is the PIVOT-006 clinical trial?

Robert Svatek , M.D., MSCI UT Health San Antonio Lead Investigator. PIVOT-006 is a Phase III randomized open label controlled clinical trial comparing cretostimogene against observation for patients with intermediate risk, non-muscle invasive bladder cancer.
Transcript:
The goal of the therapy is to assess whether or not this drug can decrease the risk or decrease the rate of cancer.
All the patients in the trial would undergo bladder tumor removal, as is standard of care. Roughly half of the patients would be randomized to adjuvant treatment, which means treatment after the tumor’s been removed, or control, which is observation.
The patients that are randomized to cretostimogene would get treatment in terms of an induction period and the maintenance period. The induction period is weekly for six weeks. Maintenance treatments or cycles would be weekly for three weeks. And the maintenance treatment would be given roughly every three months for one year. And the maintenance treatment would be given every three months for one year.
The primary endpoint of the trial is recurrence-free survival, which means the duration of survival where there’s no evidence of cancer relapse.
It is an open label trial, which means that the patient and the investigator will know which arm the patient is put into, so they’ll know which, obviously if they’re getting the drug or a control. Also, patients that are placed onto the control arm allowed to receive the drug if they experience relapse during the course of the study.
In addition, the trial will assess the patient reported outcomes with regards to their quality of life and their symptoms to ascertain whether or not the drug has a significant effect on their quality of life and patient reported outcomes as well.
The trial aims to enroll approximately patients and this will be at sites across the country.
There will be different avenues for patients to inquire about the study. Online, you could look at clinicaltrials.gov, which list all clinical trials that are currently available and you could get information from there. Also, the Bladder Cancer Advocacy Network, or BCAN, will have information about the study on their website. But I would start by asking your urologist if they’re participating in the trial or if they know of a site that is nearby that you could participate in.
If you’re a patient with intermediate risk, non-muscle invasive bladder cancer, you’re currently facing a situation of uncertainty with regards to whether or not a tumor will relapse. And you’ll have some options to discuss with your doctor with regards to commonly used medications. But if you are interested in being a part of a clinical trial of testing this novel agent, this trial might be something that you would be interested in considering.

PIVOT-006 is a Phase 3, randomized open-label monotherapy study evaluating cretostimogene grenadenorepvec for the treatment of Intermediate-Risk, Non-Muscle Invasive Bladder Cancer (NMIBC). There are two study arms. One arm is transurethral resection of the bladder (TURBT), or Standard-of-Care in this patient population, and the other arm is TURBT plus cretostimogene. The study endpoint is Recurrence Free Survival.

Who to Contact

Clinical Trial Recruitment:
clinicaltrials@cgoncology.com

Medical Affairs

Sign up to receive information and updates on
CG Oncology