FAQs

This is a list of common questions that patients ask about participating in a study. If you have other questions, please make sure you include those when you talk to your doctor and the study team.

You may want to print these questions and take them with you when you talk to your doctor and/or the study team.

Download patient information on this study:

Download your Doctor Discussion Guide to help guide conversations on this study:

General Study Questions:
Do I meet the requirements to join this study?

Please try the eligibility questions click here and consult with your Urologist.

How is the study treatment different from other treatments for my type of cancer?
Treatment on the PIVOT-006 trial consists of weekly intravesical doses of the cretostimogene grenadenorepvec that are instilled into the bladder. This is similar to the most common treatment for your kind of cancer. Those that receive cretostimogene grenadenorepvec will receive weekly doses 14 times over the course of a year.
As a participant in the trial, how long will the study last?
The study consists of 3 phases of participation, Screening Phase, Treatment Phase, and Follow-up Phase. The time frame of the study will be determined by your study doctor based on your unique response to the study treatment. The study Screening Phase lasts approximately 8-10 weeks followed by the Treatment phase which lasts up to 12 months, and lastly, the Follow-up phase lasts up to 24 months.
What will my responsibilities be if I participate?
Being involved in a clinical study requires a degree of commitment, such as regular hospital visits and additional tests and procedures on occasion or being contacted by phone from study staff monthly even when you are no longer receiving treatment on the study.
What are the possible benefits of participating in this clinical trial?

It is not possible to know at this time if the study treatment is better than alternative approaches, so this study may or may not help you.

What are the possible risks of participating in this clinical trial?

Please talk to your usual doctor or the study doctor about the known risks of taking part in this study.

Will I get a placebo?
This study does not include placebo treatment. All participants will undergo Standard-of-Care surgical treatment. 50% will be randomized to receive cretostimogene intravesical treatments. The other participants will undergo observation after their surgery. If participants in the observation have a recurrence of IR-NMIBC, they will be offered cretostimogene treatment.
Will I be able to take my regular medications while participating in the study?

You should be able to continue to take your regular medications while participating in the study; high dose oral steroids and some anti-viral medications are not able to be taken while a trial participant.

What if I am pregnant or breastfeeding, or become pregnant during the study?

Participants who are pregnant or breastfeeding may not participate in the trial. In order to participate in the study, both men and women of child-bearing potential must follow highly effective birth control methods. If you become pregnant while on this study, the study drug will be stopped immediately and permission to collect information about the pregnancy until conclusion will be requested.

Who will oversee my medical care?
A urologist trained in the conduct of the PIVOT-006 trial will oversee your medical care as it relates to your bladder cancer. For any other medical conditions, you continue to see your usual healthcare provider.
Will the study doctor work with my doctor?

Yes, the study doctor can coordinate your care with your usual healthcare provider.

Will I be able to work while participating in the study?

Yes, you will be able to work while participating in the study.

What support/resources does the study team offer to participants and caregivers?

You will be given a Patient and Caregiver Information sheet with information on precautions to be followed while you are receiving the study treatment.

Where will I go to participate in the study?

Please refer to study sites map for locations of participating clinical sites.

Will I have to stay in a hospital to participate in the study?

No, this trial does not require hospitalization to participate.

Can I stop participating in the study after it has begun?

Taking part in this study is voluntary. You may choose to not take part in the study or you may leave the study at any time without giving a reason.

Will I have to pay for any part of the study, such as tests, procedures, or the study drug? Will my insurance cover these costs?

The study Sponsor, CG Oncology, will provide the study treatments at no charge while you take part in the study. Additionally, the study Sponsor will pay for all study-related costs that are not considered a routine part of your care.

Will there be travel or childcare costs I need to consider while participating in the trial?

You may have the opportunity to receive compensation for travel, parking, and meals dependent upon which study site you are receiving study treatments and procedures.

Can I participate in the PIVOT-006 Study if…
I am currently participating in another study?

If you are receiving active treatment with another investigational drug, you will not be able to participate in this trial. However, if your treatment phase on that trial has been completed, and you are currently in follow-up phase, you may be enrolled in this study, if all entry requirements are met.

I have previously been treated with chemotherapy?

Please consult your usual doctor or study doctor for further details on your eligibility.

I am currently on or have received chemotherapy treatments for bladder cancer?

You may be eligible to participate in the study, please consult with your doctor.

I have been treated with BCG therapy for bladder cancer?

Yes, you may be eligible to participate.