Merck Anti PD1 Trial (BM-3475) for NSCLC - 1260259

tvoltagg
Posts:30

My wife was just enrolled in this trial at U of Penn. She was randomized to the once every 2 weeks schedule.
The trial nurse mentioned that the last 3 people she enrolled were on the every 2 week schedule. Does anyone know if there has been any information about the benefits or lack thereof for once every 2 weeks, versus once every 3 weeks?

Also, is there any information about the types and frequency of side effects for the NSCLC folks? I see quite a bit on the melanoma arms. Would they necessarily be the same?

Tom

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Reply # - November 2, 2013, 04:54 PM

wendyp
Posts: 12

I am a stage 4 melanoma patient on Merck pd1 trial since 12/2011. I had multiple tumors in both lungs, on my chest & in my leg. My first 12 week scans showed NED. I am on a 10 mg and 3 week schedule.

My understand is that it really does not matter if you are on a 2 week schedule or a 3 week schedule. If you are going too respond to PD1 your infusion schedule is not an issue. However, on the interim data for melanoma patients there was a higher response rate at 10mg rather than 1mg, 2mg or 3 mg.

Mk3475 is my "miracle drug" and I hope that your wife is also a responder.

Tom, good luck to you and your wife. Stay strong and be patient waiting to see if she is a responder. One sign to look out for is your wife getting side effects. Side effects is an indication that the drug is effecting her immune system and this would be a good thing.

Reply # - November 2, 2013, 06:17 PM

tvoltagg
Posts: 30

wendyp,

Thanks for your information and kind words. So you may be a treasure trove of information about side effects to expect. Would you mind sharing? Thanks and continued good wishes.

Tom

Reply # - November 3, 2013, 04:32 PM

wendyp
Posts: 12

Tom.

It is my pleasure if I can help other cancer patients. I am so grateful to be a "complete responder" for MK-3475.

When first I started the trial, I had NO side effects. Then within 2 months, I lost some function of my thyroid. I now take daily meds to regulate my thyroid. Hypothyroidism is a common side effect for this drug.

Other common side effects that I personally have experienced are: itchiness, fatigues, skin rash and joint pain. At times, these side effects were severe for me. My doctor told me that my severe side effects was an indication that I had a strong immune system. My doctor was correct.The drug worked fast with my immune system to kill the cancer. I was NED after my first 12 week scans. I just had my 89 week scans on the Merck PD1 trial and I am happy to report that I am still NED.

There are other side effects with MK-3475. Here is a link that you might find informative:
http://www.mercknewsroom.com/press-release/research-and-development-new…

If I can be of further assistance, please post your questions?

Stay Strong and be Patient!
Wendy

PS.My husband's name is Tom and has been my "rock" throughout my cancer journey. Tom's are good guys :-)

Reply # - November 3, 2013, 05:28 PM

costica
Posts: 99

Does anyone have any info about Merck's PD-1 trial in lung cancer? I spent a lot of time today and I found nothing. I could not even locate the trial tvoltagg is mentioning on clinicaltrials.gov.

Reply # - November 3, 2013, 05:38 PM

tvoltagg
Posts: 30

costica,

The trial identifier is: NCT01295827
The title is: Study of MK-3475 in Participants With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, or Non-small Cell Lung Carcinoma (P07990/MK-3475-001)
The link is: http://clinicaltrials.gov/show/NCT01295827

My wife is going to the U of Pennsylvania Hospital trial site

Hope this helps.

wendyp,

Thanks for the info and the web site. It's greatly appreciated. Keep up the good response!

Tom

Reply # - November 17, 2013, 05:04 PM

tvoltagg
Posts: 30

Thanks, Wendy. So far, so good. My wife has had 2 infusions so far and she has had no real effects, except perhaps for some fatigue, although she changed her pain meds around the same time and we're not sure if the fatigue is from that or the Merck drug. Even if it is from the Merck drug, we are not complaining!. The first scan will be around New Years and we will be hoping for results like yours. One good thing this week was that the oncologist really was happy about the minimal progression during the time between the last chemo and the start of the trial, as well as how good Joan was feeling. Our fingers are crossed.

Tom

Reply # - November 25, 2013, 10:36 AM

carrigallen
Posts: 194

Regarding question of schedule every two vs. every three weeks: Most studies with this class of monoclonal antibodies have shown that larger doses every three weeks can achieve the same blood levels as smaller doses every two weeks.
This is because most of these type of monoclonal antibody drugs spend a long time in the blood before they are gradually metabolized. In theory, the benefit to every 3-week dosing may be fewer office visits. Hope this helps.

Reply # - November 25, 2013, 11:42 AM

tvoltagg
Posts: 30

Thanks, Dr Creelan.

I may be wrong, but I was told that for my wife's trial ((P07990/MK-3475-001), the dosage is the same for the every 2 week and every 3 week interval. In both cases they are 10mg/kg body weight of MK 3475. Earlier arms had 1mg, or 2mg as well.

Tom

Reply # - December 13, 2013, 07:44 PM

tvoltagg
Posts: 30

Hi Wendy,

We are 4 infusions into the trial and so far no side effects to speak of. She is feeling fine and we are anxiously awaiting the first scan on Jan 2.

Have a great holiday.

Tom

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