Cretastimogene Grenadenorepvec: Anyone in the PIVOT-006 Study?

I had TURBT in November,2024, low grade, intermediate risk, non invasive tumor. Have had 6 intervesical treatments, without side effects. Several days ago, had Cystoscopy and everything clear. Starting this week, will get 3 maintenance treatments, weekly. Phase 3 of trial. This is first intervesical treatments.

@nihifam4, I thought I'd post a link to the PIVOT-006 study in case anyone is interested in reading more:
- A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT https://clinicaltrials.gov/study/NCT06111235

Did you and your husband decide to go on the trial?

New to forum
I am 81 year old male. Been dealing with non muscle invasive BC for 13 years.
Have experienced 11 reoccurrences since initial TURBT all requiring TURBT. In past year I have received 6 monthly Gemcitibine installations that have not prevented reoccurrences.
Proton beam therapy for PC left severe radiation cystitis issues in bladder.
Obtained partial improvement in cystitis after 40 Hyperbaric oxy trmts.
Currently being offered opportunity to participate in drug trial for non invasive BC using drug named Cretostimogene . Any experience with this drug would be appreciated.

Hello Fred,
I hope you can find someone on Connect with experience with this new drug. I see it was fast tracked through the FDA due to its high efficacy in trials. It says that secondary side effects were minimal and low grade. That might be an important factor for you since you have bladder damage from the proton beam therapy. Is that drug trial through Mayo or elsewhere?

Where were you offered the clinical trial? I'm from Florida.
Thanks
Francis

Hello,

I was diagnosed low grade NIMBC in December 2023, had TURBT, Mitomycin and a course of BCG.
The dctor found high grade NIMBC cardinoma in situ in January 2025, and I had an intravesical treatment of Adstiladrin in March. I have a cystopscopy scheduled for June 4th and I will know if I've achieved a complete response. I'm 70 years old. I had not heard of Cretostimogene prior to Fred's posting. I am thinking ahead, in the event that the Adstiladrin doesn't work. I'm trying to learn more about neobladders, which facility and physicians are best at the procedure, and - now - whether it would be a good choice to try Cretostimogene as a preliminary option, before surgery. I am in Omaha, Nebraska. Did you have to make application to participate in the Cretostimogene program? Was it something your doctor suggested? I'd appreciate any information you may have to share.

Dave

@sparkyconnect, I moved your question asking if anyone is taking the mmunotherapy called cretostimogene grenadenorepvec to this related discussion where you can connect with @nihifam4.

- Cretastimogene Grenadenorepvec: Anyone in the PIVOT-006 Study?https://connect.mayoclinic.org/discussion/cretastimogene-grenadenorepvec-research-treatment/

@sparkyconnect, did you decide to take part in the clinical trial?

I just enrolled in the trial at Mayo Jax.
Scheduled for randomization in approx 3 weeks. Hopefully will be in the initial treatment arm of the study. Everything I have researched suggests this may a breakthrough treatment.

Just enrolled in trial at q Mayo Jax.

Just enrolled in trial last week at Mayo Jax
Initial treatment to start in approx 3 wks