Clinical trial botensilimab/balstilimab

[L0729]

Clinical trial NCT05608044
Has anyone joined the clinical trial for botensilimab/balstilimab? Curious of any feedback, believe it is in phase2. eligibility requirement of No liver Met involvement at this time, so I would not be able to do this but looks interesting.

[LynnMarie]

Several people on ColonTown (facebook) have reported being on this trial. It's fairly new, but seems to be having best results when there are no liver mets.

NCT05608044

I believe one person was taken off of the trial because of progression, but the others are still in it. One person has been on it since 3/2023. Several of them have KRAS mutations.

[Bpaint]

My husband is hoping to get into a bot/bal trial next, now that folfiri and panitumumab have run their course. I’ll update on here if he gets into one. Hate that it is random and he could end up being assigned to a standard of care line.

[L0729]

My husband is hoping to get into a bot/bal trial next, now that folfiri and panitumumab have run their course. I’ll update on here if he gets into one. Hate that it is random and he could end up being assigned to a standard of care line.

Hi Bpaint,
It seems like some people are seeing results on this trial. I’m not sure how many have difficulties with side effects such as colitis? I hope your husband gets in this trial and on a treatment arm!!!! Does the trial allow crossover? If he gets assigned to soc and progresses will they allow him access to the trial drug?

[Bpaint]

Apparently the trial does not allow crossover. My husband's oncologist recommends that if he gets assigned to the standard of care arm that he withdraws from the trial because he doesn't think Regorafenib would do anything. It is sort of infuriating that this SOC arm is even there at all. City of Hope in LA seems to be the only place with a nonrandomized Bot/Bal trial going, which combines Bot/Bal + Regorafenib, but the travel from Wisconsin to LA would be difficult for us. We will strongly consider it if he doesn't get into a Bot/Bal treatment.

The other option we are considering is a Cabo/XL092 trial--this also has good preliminary results in people with only lung mets, but the sample size for the early trial was really small. The trial has expanded to nationwide trial that is randomized, but at least two place I contacted still have slots in the nonrandomized earlier trial.

It is sooo hard to choose when knowing that whatever you do choose will disqualify you from doing another similar immunotherapy trial later.

[Bpaint]

Update on bot/bal trial: the phase 2 trial closed before my husband could get in, and phase 3 trial will be for first-line patients only. But! His oncologist applied to the company for compassionate use access to the drugs and we were approved, so he will be starting in 3 weeks, after Folfiri washout period.

I’m feeling hopeful because right now he has only lung nodules, with maybe some new lymph nodes, and lung-only metastasis seems to have the been chance of success on this trial.

NIH also contacted us about TIL, because his latest scans now show a lung nodules large enough to harvest. We are setting an appt there for after his first scans on bot/bal, and will cancel if the trial drugs are working.

[debb]

Hi Bpaint,
I sent you an email because I too have just been accepted for compassionate use of Bot/Bal. I was hoping we could share experiences.

[Bpaint]

Yes, definitely. He will hopefully be starting in the next 3 weeks. There seems to be a lot of red tape to get the drugs.