Clinical trial / study: BRCA mutations

[cbgjr]

I just started participating in a clinical study at MSKCC. The objective of the trial is to determine whether two drugs, when given simultaneously, perform better than when used individually. The study will evaluate the results on various types of cancers with BRCA1/2 and ATM mutations (breast, ovarian, PC, etc).

The two drugs are Talazoparib (PARP inhibitor) and Avelumab (Immunotherapy, Checkpoint inhibitor). Supposedly lab tests showed that there may be a synergistic effect between them, attacking the cancer from two fronts. Both are made by Pfizer, the trial sponsor.

I have the BRCA2 mutation, and when it became clear nothing was really working for me (lupron, taxotere, abiraterone), my MO contacted MSKCC to get me in the study. A PARP inhibitor would have been the next thing on the list, anyway.

I post this in case somebody is in the same boat as me and may be interested. They are still enlisting recruits. The sponsor supplies the drugs at no cost.

This is a nation-wide study, not just at MSKCC...

CG

[CantChoose]

Very interesting. Thank you, and wishing you a good outcome!

[tango65]

Patients with BCRA mutations can have a positive response to PARP inhibitors alone. ncbi.nlm.nih.gov/pubmed/307...

Let us hope that the combination with a PD-L1 inhibitor will be more effective.

[cbgjr in reply to tango65]

thanks!

[NPfisherman]

It's the way of the future....combining several different drugs and increasing success rates...Best of luck...Hoping for the best for you...

Fish

[HopingForTheBest1]

Also BRCA2+. Zytiga/Prednisone only lasted 6 months when PSA started rising back from 0.12 to 0.55 in just 3 months. Started on PARP Olaparib 2-3 months ago. PSA down back to 0.13 after just 3 weeks. Also had Provenge treatment completed 2 weeks ago.

When I asked my Oncologist about Talazoparib, a newer second generation PARP, he told me it was too new and there were insufficient studies that show it more effective than Olaparib.

What is the name of this trial? Is it phase 3? Is it randomized or does every participant get the drugs? I would expect I may not qualify for this new trial as I am already on a PARP.

Wishing you luck and success. Looking forward to future updates from you.

[cbgjr in reply to HopingForTheBest1]

Hi, HFTB1:

the trial name is Javelin Parp Medley. gov identifier: NCT03330405. It is now phase 2.

It is not randomized, so everyone gets the same two drugs. They are trying to get data on pfs and os for the various types of cancers being studied.

yes, unfortunately, previous PARP treatment is a dis-qualifier.

I'm glad to hear how well you are doing with a PARP inhibitor alone, hope it lasts for a long time! My experience with Zytiga was similar to yours, except that for me the PSA never got below 4.2 - 4.4 and it started rising from there in <5 months...

Take care, and best wishes to you too.

CG

[2dee]

Thanks for posting.

I could need in future.

2Dee

[j-o-h-n]

Could Be Great?.....jr

Happy Eastern Orthodox Easter.

Good Luck, Good Health and Good Humor.

j-o-h-n Sunday 04/28/2019 4:29 PM DST

[Don_1213]

My med-oncologist brought this up at our meeting last week. He was quite excited by it and explained to me the theory behind it. He's Dr. Charles Drake at Columbia University.. and Co-director of their immunology research programs. If he's excited I expect to hear good things about it. Not applicable to me since my PSa is currently undetectable (Lupron and IG/IMRT/ARC 45 treatments.)

[p3d1]

Hope the trial is going well for you. Read elsewhere that your SE are causing you trouble. It is hard to tell which drug could be causing these. I am on a trial with PARPi alone. No SE yet. Can I ask you if your BRCA2 was germline or somatic? My BRCA2 is somatic only.

[cbgjr]

thank you. BRCA2 was not germline. MSK was sure that my previous mild anaemia was aggravated by the PARP inhibitor, not the check-point inhibitor. So they stopped just the PARPi for two weeks then resumed it at a reduced dosage (25% lower) to see if the blood count can be maintained at a reasonable level. Two months into the trial, scans showed that disease progression was halted, but not yet reversed. PSA initially showed a slight trend up, but latest blood tests showed that it is starting to drop.

How long have you been in your trial, which PARPi is involved and what kind of results have you seen so far?

Best,

CG

[p3d1]

Hi cbgjr,

Apologies for not replying sooner. I have been on the trial for over 6 months, PARPi used is Rubraca. Results so far are 50% reduction in the tumour and over 59% reduction in PSA, my PSA also showed a slight increase at 2 weeks but then started to fall. I still have no side effects. Next scans in 12 weeks so hoping it keeps working. How are you doing on your trial?

[Silverligh]

Hi Cbgjr

Could you plz share the contact person info for the study intake. I am in a similar situation.

Thanks