Clinical Trials Question: Did you have to research and bring up the possibility yourself, or was it

I recommend doing both. I'd research myself and get some ideas, and then I'd go and talk to the doctors that are listed as the point of contact for those trials and get their opinion. For each trial, they list specific doctors at specific institutions as a point-of-contact. I believe those doctors are the best to discuss the trial with. Doctors not participating in the trial probably won't have much knowledge or interest in it. They will go with approved treatments. If you have interest in trials, you need to see the doctors doing research, not just those that are treating with approved treatments. The latter will use the approved treatments until and if they become inneffective, and only then will they recommend a trial. (This approach is also ok, if that's what you want to do).

You can narrow your search a lot by several things. First, by your location and how far you're willing to travel. I knew I wasn't willing to travel beyond a 1-2 hour drive from my home unless there was something that looked really to be likely to be beneficial. Second, many of the studies have a very detailed list of criteria of what patients are admitted to the trial. If you go through those, you can usually figure out if you're qualified for the trial. If it's some criteria that is close and you're interested in the trial, I'd go talk to them anyways. Sometimes they do make exceptions. However, often times it's very clear you aren't eligible. For example, for the trials I looked at, you had to start them within 12 weeks of your nephrectomy and you couldn't have any other evidence of disease.

There is probably some kind of standard of care that has to be tried first before other things can be tried, so the doctor may be required to try the approved drugs first. If you don't want to go that route, it's going to be up to you.

Why not ask the doctor why? I know this can be tough. They are often in a hurry, or aren't willing to have a technical discussion with patients about the reasons, etc. However, you might have to push a little. If you didn't get all your questions answered, I strongly urge you to go back and see your doctor and ask your questions. You should know why you're doing what you're doing and I think you should be sold on your treatment (or at least sold on trusting your doctor). Get other opinions (it sounds like you have and I'd keep it up). I felt better when I saw 2-3 specialists and started seeing a consensus. And by the way, one of those three opinions was actually completely wrong and he was the first one I talked to...

Todd

The following is just my opinion from what I have experienced.

After reading Fox’s posts here on CSN I have been actively pursuing entering ANTi-PD-1 (Nivolumab) clinical trial. I started this quest since shortly after starting treatment in July of 2012. I have discussed upcoming clinical trials with my oncologist at almost every meeting. I have also traveled to two major cancer hospitals outside of my area in order to discuss upcoming clinical trials. The answer has always been the same – No! The reasons seem to fall under the following categories

1.      Patients must be treatment naive for which I am not (For example, the Argros Adapt study using AGS-003)

2.      At the time, I was progressing well on my current medication Votrient/Panzopanib. The doctors would not consider having me stop my current treatment in order to enter a clinical trial. Even though that trial I was requesting was Votrient/Panzopanib in combination with Nivolumab.

3.      As of now, most clinical trials involving Nivolumab are now no longer recruiting new patients.

4.      ANTi-PD-1 Clinical trials may be filled before you are ever aware of them    

I am coming to the sad conclusion that finding clinical trial that would be most beneficial to me is like chasing rainbows. As of now, I feel I am condemned to the standard line of FDA approved therapies. Hopefully, I will still be alive when Nivolumab finally receives FDA approval for renal cell carcinoma (About 2016). - BDS  

NanoSecond said:

I hear and echo your

I hear and echo your frustration.  But don't give up.  I almost did (for the second time as I mentioned earlier) but then serendipity struck...

To make an amazing story short, if the CT-scan of my brain (performed earlier today) comes back clear I will be joining a clinical trial being conducted at the NIH/NCI of a new anti-PDL1 drug starting this coming Monday (24th).

What is even more absurd - I only found out about this clinical trial one week ago.  It had been under everyone's radar - even my high level contacts at the NIH/NCI.

The lesson is you just have to keep researching and calling - and then depend on pure luck.  In my case, my wife and I were alerted to the existence of this trial by Dr. Hans Hammers at Johns Hopkins.  He and his associate, Dr. Mark Markowski, are simply gems.  Like so many other patients of theirs, I can't say enough good things about them.

 

Great news Neil. Hope it works for you.! Ron

NanoSecond said:

I hear and echo your

I hear and echo your frustration.  But don't give up.  I almost did (for the second time as I mentioned earlier) but then serendipity struck...

To make an amazing story short, if the CT-scan of my brain (performed earlier today) comes back clear I will be joining a clinical trial being conducted at the NIH/NCI of a new anti-PDL1 drug starting this coming Monday (24th).

What is even more absurd - I only found out about this clinical trial one week ago.  It had been under everyone's radar - even my high level contacts at the NIH/NCI.

The lesson is you just have to keep researching and calling - and then depend on pure luck.  In my case, my wife and I were alerted to the existence of this trial by Dr. Hans Hammers at Johns Hopkins.  He and his associate, Dr. Mark Markowski, are simply gems.  Like so many other patients of theirs, I can't say enough good things about them.

 

So glad to hear about this! Hope that scan turns out ok and you start this trial soon.

Todd

BDS said:

Chasing rainbows

 

 

The following is just my opinion from what I have experienced.

After reading Fox’s posts here on CSN I have been actively pursuing entering ANTi-PD-1 (Nivolumab) clinical trial. I started this quest since shortly after starting treatment in July of 2012. I have discussed upcoming clinical trials with my oncologist at almost every meeting. I have also traveled to two major cancer hospitals outside of my area in order to discuss upcoming clinical trials. The answer has always been the same – No! The reasons seem to fall under the following categories

1.      Patients must be treatment naive for which I am not (For example, the Argros Adapt study using AGS-003)

 

2.      At the time, I was progressing well on my current medication Votrient/Panzopanib. The doctors would not consider having me stop my current treatment in order to enter a clinical trial. Even though that trial I was requesting was Votrient/Panzopanib in combination with Nivolumab.

 

3.      As of now, most clinical trials involving Nivolumab are now no longer recruiting new patients.

 

4.      ANTi-PD-1 Clinical trials may be filled before you are ever aware of them    

 

 

 

I am coming to the sad conclusion that finding clinical trial that would be most beneficial to me is like chasing rainbows. As of now, I feel I am condemned to the standard line of FDA approved therapies. Hopefully, I will still be alive when Nivolumab finally receives FDA approval for renal cell carcinoma (About 2016). - BDS  

 

To Neil's point, when I first started Nivolumab, it didn't have a name. It wasn't the drug that everyone wanted to take. I had to fight with my urologist because the doctor I wanted to see was involved with immunotherapy and melanoma. He wasn't a kidney specialist In my urologist's eyes. Keep in Mind these two doctors practiced in the same hospital system and had offices less than 12 miles apart.

My thought supports what Neil and Fox are saying. Keep looking and be open to finding any answer. If you narrow your search to one thing, you will only find one thing. Be open.

Along those lines, look for the Merck Anti PD-1 drug. there was a press release lately that it now has FDA special approval for use in melanoma. Nivolumab wasn't successful enough to gain that distinction. I believe I saw that they will soon open the drug to RCC trials. My doctor was more excited about that development than he was about Nivolumab. I saw the article at onclive.com, but I didn't follow up with any search for locations or time frame of when it will be offered. 

I also agree that if your doctor isn't involved in trials, he most likely won't be a big seller of trials.

Darron said:

Merck -3475?

Neil

is that the Merck trial?

Thanks to all of you who have expressed your good wishes.  However, I am still a bit superstitous.  I will not hear the results of my CT brain scan until Monday morning.  If it is clear I will be checking into the NIH/NCI hospital that same afternoon.  I will get my first infusion of an anti-PDL1 made by EMD Serono (not Merck) on Tuesday morning.  Then I have to stay in the hospital for observation until Thursday morning.  Future infusions will not require any hospital stay - just the initial one.

My advice to anyone looking for an anti-PD1 or anti-PDL1 trial is to concentrate on BMS's competitors - Merck (as mentioned by Darron) but also Genentech and MedImmmune.  They have or will be introducing new clinical trials over the next few months.  Many of them will be dose escalations studies (such as the one I hope to start on) but a few will be cohort expansions (which may be more restrictive).

Here is my trial - but I believe it is no longer open to RCC patients:

http://www.clinicaltrials.gov/ct2/show/NCT01772004?term=emd&rank=101

Finally, there is one bit of bad news.  If I start on this trial on Monday I will have to cancell my trip out to San Diego to attend the 2014 AACR (American Association for Cancer Research) Annual Meeting.  That means I won't get to meet Ron (or anyone else attending from CSN or SmartPatients).  That is extremely dissappointing.

BDS said:

Clinical Trial

 

Dear Nanosecond 

            Normally I really really do not like posting the names or conversations that I have had with doctors on the internet. But in this case I am really going to make an exception. I met with Dr Hammers on March 20th about possible entering the clinical trial of a Nivolumab and rIL-21 at John's Hopkins. As my luck would have it the trial was canceled/pulled by BMS the day before our meeting (And you wonder why I am frustrated!). Dr. Hammer told me for my next treatment  I had three options 

1.     Go on Axitinib/Inlyta

 

2.      Go on HD-IL2. I can tell that my current oncologist is dead set against HD-IL2. I know when I suggested that I am now considering this option she will hit the roof. 

 

3.      Wait for a possible clinical trial that I may or may not be eligible for involving Merck PD1 and CTLA4. Has Dr. Hammers put it  - "I do not want to I do not want to dangle a sausage in front of you". (Very German ) He said he would let me know if I was eligible within a week.   - BDS

Yes, I had heard of last minute cancellations of several trials.  That's when I was about to give up. 

The trial I am (hopefully) about to start on had a very last minute change and opened up for just a few more participants.  That is why it was under everyone's radar and why I say that a very large part of finding a suitable trial comes down to dumb luck. Unfortunately.

Still, did you look into this one?  It is temporarily on hold:

http://clinicaltrials.gov/show/NCT01441765

GSRon said:

Neil, and here I was all set

Neil, and here I was all set for you to be my dinner date in Sunny Eggo...  But, the start on the new treatment has to be a much better date than me..!!  I will try to share what I learn...  I am thinking great thoughts for you...  In my family, Mondays were thought of as good days... and Thursdays are even better... sigh...  Hang in there... hope this treatment does in the Crud..!!

Ron

I have  been in the nivolumab/votrient trial since May,2012. It was recommended by my oncologist Dr. Hans Hammers. He mentioned the trial at our very first meeting in Oct. 2011, before I had my nephrectomy. I have praised him many times on this board, and consider myself very fortunate to have him as my doctor. It's really good to see others having such a high opinion of him. He truly has changed my life.

Neil, that is great news. If your appointment with Dr. Hammers is still on for the 27th I'd like to meet you, schedules permitting, and buy you a bottle of water (or whatever your drink of choice is these days).

NanoSecond said:

Meeting

Well I'd love to take you up on that offer.  However, that appointment was cancelled when I got to see him earlier.  If I had not gotten into the clinical trial I was slated to see him next on April 17th.  But if I start that one will be cancelled too.

But certainly one of these days we should be able to cross paths.  I'll let you know when my next visit may be.

Looking forward to it.  Water will have to do.  That or green tea.  I can see Fox is cringing because he thinks it should be over a beer...

....no pizza?

NanoSecond said:

Pizza or Beer?

Well I just can't seem to decide which is worse.  Beer offers all those excess carbs (that's the major problem; not the alcohol) and pizza is heavy on carbs (starting with the dough made from wheat) plus all that added sugar (in the tomato sauce).  The cheese is quite healthy but only if it comes from a grass-fed cow; same goes for the pepperoni and sausage. It's a tough choice... 

There's none left!