Anyone have any direct experience with the COMBAT trial? BAT with Nivolumab

[Longterm101]

I have a friend considering it

Any insight would help

[cesces]

Bat is really great when it works.

For a lot of people it doesn't work.

One common early error was to use an insufficient level of testosterone.

Sartor, at Tulane, worked on the original trial. Last I talked to him he was a believer in going straight to high levels of testosterone and keeping it there.

[Tall_Allen]

Here's what I know. There's a link to the COMBAT trial:

pcnrv.blogspot.com/2016/09/...

The key is to watch it closely. Some patients get a PSA response, others get much worse. Sometimes it restores Zytiga/Xtandi sensitivity. They haven't yet figured out how to select patients for it. I hope it works for your friend.

[kaptank]

Nivolumab (Optivo) is an agent for small cell cancer/immunotherapy/ checkpoint inhibitor agent. Usually used after platinum chemos have failed. If your friend is in this class, grab the opportunity. The BAT will probably do no harm, and may help. I did BAT but in different circumstances and found it reversed treatment resistance for a time and controlled the bastard's growth. No bad side effects (some good). Monitor closely, which he will in a trial.

[BruceSF]

Here’s a quote from dr Antonarakis at Hopkins from the jan-feb Prostapedia. Apparently there’s some nice synergy between the bat and the nivolimab:

"At Johns Hopkins, we are doing some interesting and novel things to try to make PD-1 inhibitors work better. One of the most exciting things that we’re doing, which is unique to Johns Hopkins, is using a paradoxical approach

for the treatment of metastatic prostate cancer. We call this treatment bipolar androgen therapy, or “BAT” for short. BAT uses supraphysiological doses of testosterone, also called high-dose testosterone, as a treatment for castration-resistant prostate cancer. Previously, we published that one- third of castrate-resistant prostatecancer patients who receive high- dose testosterone bene t from that treatment.

"We’ve also shown that high-dose testosterone can stimulate anti-tumor immune responses. In particular, we have shown that BAT stimulates a pathway called STING (stimulator of interferon genes). We are now doing a study where we give patients with metastatic prostate cancer BAT followed by treatment with Opdivo (nivolumab) {it's just like keytruda - bz}, which

is the PD-1 inhibitor from Bristol- Meyers Squibb. We are seeing quite unprecedented results that seem to be much greater than what we would expect with either agent used alone. The combination of high-dose testosterone plus Opdivo (nivolumab) is something that we are eagerly pursuing as we speak.

"Do you have a clinical trial for testing this that patients could enter?

"Dr. Antonarakis: We do. The trial

is called “COMBAT” (COMBination of Bipolar Androgen Therapy with Nivolumab) and is currently ongoing. The patients all have to have castration-resistant prostate cancer. It’s otherwise quite open-ended. We require a mandatory soft tissue biopsy at baseline since we want to learn more about the immunological mechanisms that explain how these drugs work. If a patient has only bone disease and they’re not eligible for a biopsy, then they cannot participate unfortunately. Other than that, it’s for a relatively broad population of metastatic castration- resistant prostate cancer patients."