Cretastimogene Grenadenorepvec: Anyone in the PIVOT-006 Study?

Posted by nihifam4 @nihifam4, Mar 29 10:00am

Husband has had 5 Transurethral Resections of Bladder Tumor (TUBT) since 1999. Tumors low-grade cancer until now. Last surgery 5 tumors, high-grade cancer. The doctor wants him to do this Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus observation for the treatment of intermediate risk non-muscle bladder Cancer. Is anyone in this study?

Interested in more discussions like this? Go to the Bladder Cancer Support Group.

Thanks. I’m still waiting on my results from my BCG. Can I enroll now or do I have to show that the BCG did not work..
Fran

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Profile picture for sparkyconnect @sparkyconnect

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

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I wish you the best, and hope you are included in the initial teratment arm of the study. Please consider posting about your ongoing experiences with the trial and, I sincerely wish, the successful results.

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Profile picture for sparkyconnect @sparkyconnect

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.

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What is the protocol? Is it put in the bladder like the other treatments? How many and how often?
Thank you
Fran

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Profile picture for djr5 @djr5

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

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headed for treatment with Adstiladrin within 2 weeks, 2 TURBT's tested lesions and came back positive. The cost for this new drug is out of this world but trials have really been promising

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Profile picture for vejan738 @vejan738

headed for treatment with Adstiladrin within 2 weeks, 2 TURBT's tested lesions and came back positive. The cost for this new drug is out of this world but trials have really been promising

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I hope all goes well for you. You may want to bring a book or music/earphones to the treatment. Once it is administered, you have to stay on the table for an hour. Godspeed!

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Profile picture for fmfran @fmfran

What is the protocol? Is it put in the bladder like the other treatments? How many and how often?
Thank you
Fran

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Trial info is available at CG Oncology website.
Very informative

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I have been in this trial since January, 2025. Have received 6 initial weekly intervesical treatments, then month 3 a cystoscopy, then 3 weekly treatments, then month 6 cystoscopy, followed by 3 treatments. Scheduled for 9 month cystoscopy. If clear, then 1 treatment. Month 12 scheduled cystoscopy, followed by final treatment.
Main side effect is burning urination for a day after treatment, though last treatment had blood in urine and some passing clots for few hours after.
Treatment at Houston Methodist.

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