Difficulty getting in Ipilimumab/ Nivolumab trials?

[WifeOfMike]

Difficulty getting in Ipilimumab/ Nivolumab trials?
IF anyone here, or anyone you know in the Cancer world anywhere is having issue getting into this particular combination trial I would LOVE TO HEAR your/ their stories.

*Abnormal wait times
*bumped from position in line
*told NO positions available
*particularly MSI stable position
*anything on or off the record
*anything "unusual"

A Study of Nivolumab and Nivolumab Plus Ipilimumab in Recurrent and Metastatic Colon Cancer (CheckMate 142)
MSI Positive Colorectal Cancer (means INSTABLE or MSI-HIGH)
MSI Negative Colorectal Cancer (means STABLE or NON-MSI HIGH)

Allocation: The Microsatellite Instability High (MSI-High) Part of the trial is Non-randomized (This means you would get BOTH Drugs)
The Non-MSI high part of the trial contains a randomized portion (This means you would get BOTH Drugs OR just NIVOLUMAB)

http://clinicaltrials.gov/show/NCT02060188

Thank you,
Vicki

[Kathleen808]

Hi Vicki,

What's the number on that trial? Is there a problem that you are encountering? We are still trying to figure out if the microsatelite stability is going to be an issue in the immune therapy trials. What have you found out?
Aloha,
Kathleen

[WifeOfMike]

YES THERE IS SOMETHING STINKY going on with this Clinical Trial
I am going to dig in to get to the bottom of it

I added the Clinical trial number And more info in the First post
I am REALLY interested in talking with anyone who is having issues, OR who is actually in this trial
Vicki

[WifeOfMike]

These are the locations in the United States & the recruiting status per CLINICAL TRIALS.GOV

Arizona
Contact: Site 0028 Not yet recruiting
Gilbert, Arizona, United States, 85234

California
Contact: Site 0004 Not yet recruiting
Los Angeles, California, United States, 90033

Pacific Hematology Oncology Associates Recruiting
San Francisco, California, United States, 94115

Florida
Contact: Site 0007 Not yet recruiting
Tampa, Florida, United States, 33612

Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322

Massachusetts
Site 0036 Not yet recruiting
Site 0002 Not yet recruiting
Boston, Massachusetts, United States, 02114

Minnesota
Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407

New York
Site 0009 Not yet recruiting
New York, New York, United States, 11065

North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710

Site 0029 Not yet recruiting
Winston Salem, North Carolina, United States, 27103

Oregon
Providence Cancer Center Oncology And Hematology Care- Eastside Recruiting
Portland, Oregon, United States, 97213

Pennsylvania
Upmc Cancer Pavilion Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: James Lee, Site 0013 412-647-8205

Tennessee
Vanderbilt-Ingram Cancer Ctr Recruiting
Nashville, Tennessee, United States, 37232

Texas
The University Of Texas Md Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030

[lichens]

FYI this trial is designed with MSI+ patients in mind as BMS thinks Ipilimumab will have the most effect on those patients. If your husband is MSI+ he should have absolutely no problem getting into the trial.

This trial also has an extremely small portion to test Nivolumab on patients who are not MSI+. Each trial site is only allotted 2 spots for this portion. If your husband is non MSI+ the chances of him getting into this portion of the trial is extremely low if he is not already a patient at the trial location. Going forward BMS will collect data every 6 weeks on these trial participants for analysis. They may decide to expand or to terminate this portion of the trial based on results.

I hope this clears any confusion you may have about the trial.

[Bev G]

Vicki,

If you think there is something "funny" going on with this trial (ie enrollment, preferential treatment, or whatever) I would suggest you call the folks at the NIH in the clinical trial section: 301-496-4000. Having conducted two clinical trials for drugs, and participated in another two as a researcher, I can assure that these things are regulated more than a moon flight are (sorry, I'm watching a program about the moon flight and can't think of another example). The last drug study i worked on at the Medical College of Georgia took TWO YEARS to get all the paperwork approved through the IRB, and once it was finally all done, there was only enough time left to enroll one patient. I was utterly frustrated and it was absurd, but this is a system that cannot be pushed. I think very few people actually understand everything that goes on and all of the oversight and regulations that are involved.

It is critically important that all of the drugs eventually put in to circulation, regardless of the disease they are treating, be scientifically, objectively and properly studied.It's why I think all of our pals who enter clinical trials are real heroes...we really don't know the efficacy, and the dangers, of these drugs until the studies are done. Ultimately the benefit is ours.

Bev

[WifeOfMike]

YES I think their is SOMETHING ODD going on in this particular trial

lICHENS:

Each trial site is only allotted 2 spots for this portion. If your husband is non MSI+ the chances of him getting into this portion of the trial is extremely low if he is not already a patient at the trial location.

I would LOVE to know where you are getting your information.

I have been researching this trial sense April-May and conversations all over CT hold my comments
I have had multiple PM's regarding this trial, including with our BusyMamaof3- Carlyle who kept getting bumped (I cannot erase her msgs- so I have them)

>I have been pounding down doors to get Hubby in a trial for literally Months (May 2014 until July 31)
>I wrote the BMS co emails from multiple clinical trial email sites, stating I had interest & would be willing to commute ANYWHERE (May 15th I believe- I will check my email correspondence)
>I told them Texas was recruiting, but I noticed San Fran & LA were listed as not yet recruiting but were closer
>IF they would be recruiting SOON, I would wait.

>They sent my emails directly to both LA & San Fran asking they connect with me (NEITHER location was formally recruiting)

>San Fran told me they would be recruiting about same time frame as LA & & it would be smarter to wait & get closer to home
>I told her save spot for me, notify me when open & we could fly up. She went on vacation, I checked in several times......
>next notice: from another person San Fran recruiting, but all spots taken, sorry

>La notified me same timing, said make appt with DR.. I did for June 9th> when were OFFICIALLY put on their CLINICAL TRIALS WAIT LIST
>at appt DR told me they were not recruiting yet, but didn't think hubby qualified (hubby MSI Stable). I showed him trial NCT# with 2 arms noted.... he seemed surprised
>Confused, I clarified that with our darling MAIA and San Francisco.... YES MSI-Stable are included
>In the meantime we were introduced to 4 clinical trials- 2 excluded because he is KRAS Wild, 2 because his CBC pre-qualifying tests- the liver test was (point) .03 too high
>we were told another trial coming down pike 2-3 weeks & be patient (I got excited thinking it MAY be the one we were waiting for)

>I have been continuously asking for updates via email/ calls/ Dr Visits, IPPY/NIVO not recruiting yet.... until this past Wed-Thur, July 30-31

>REPLY:Per our regulatory dept. they said it would be at least another two weeks. Let me know if you need any other information. Thank you.
>when I asked if they would be opening both arms up simultaneously-I got a second email:
>REPLY:Just confirmed with the sponsor that as the non-high MSI recruitment is now closed ([b]all the other sites had filled it). Yes they did open them at the same time and when we are activated – we will only be looking for high MSI. Sorry for the inconvenience and let us know if there is anything else we can do. Thank you.[/b]

SORRY FOR THE INCONVENIENCE?
Well, doesn't that just bite the BIG ONE?????
and yes I have ONE off the record story that is MORE upsetting

Vicki

[Kathleen808]

Vicki,
Thank you for all that information. You have done a huge amount of work for your dh. Thank you so much for sharing it. I wonder why they are not putting MSS as an exclusion criteria. I wonder who the MSS people got into the trial. Hmmmm?

Kathleen

[WifeOfMike]

I do not know Kathleen.............
However if two slots are supposed to be allotted per site...........WHERE are the two slots for my site?
All I ask is FAIR shot, just like everyone else.....I have been scratching, clawing, calling, emailing, visiting in person 1/2 day trips for 4 months

It is like winning a lottery ticket to get in any trial.........
and then you shoot for another lottery ticket & PRAY..... Pray it will be a miracle & eradicate Cancer..... OR will produce durable Response.....or buy time to find something else...
AND PLEASE don't screw him up & make it worse...(again). Cause you know- he has already done most FDA la-la drugs & IS ready, willing & able to be a human Guinea Pig for Science & Mankind (his words)

Ironically I signed a petition tonight: Speed Progress Against Cancer - Stand in Support of Clinical Trials and Cancer Research: Sponsored by Conquer Cancer Foundation
This is what part of their campaign stated....

Despite the promise offered by clinical trials, less than 5% of adults with cancer enroll in them. By contrast, more than 60% of children with cancer are enrolled in clinical trials. Approximately three-quarters of all children with cancer survive long-term, compared with half of adults. The increased survival rate for children is due in no small part to their higher rate of participation over time in clinical trials.

Well...I have been spawning upstream for NINE months in the clinical trial world.............. Don't make it so blasted HARD to get into them!
I am done venting for the evening.... sorry about this. I will be my spunky self hopefully tomorrow
Love you guys
Vicki

[justin case]

Sometimes you just gotta bump something up
Michael

[WifeOfMike]

Wanted to post this, as it is not a good story for Ipilimumab (which is typically the ONLY things you hear) and is directed to ONC's.
It also is a huge warning to anyone entering a clinical trial- to SPEAK UP- if there are any side effects, particularly with an unproven drug
You can also say that about any treatment- I wish hubby had spoken up sooner about his Stivarga HFS and the nurse/ ONC had pushed the warning bells/ preventative measures before they appeared

A Balance Between Quality Versus Quantity
Blog | August 01, 2014 | Skin Cancer / Melanoma Targets
By Monica Key, APRN, CCRN, AOCNP
I met a young man several years ago in his thirties who was dying from metastatic melanoma. His parents were at his bedside every day at the inpatient oncology unit. This young man had lost all his hair, suffered from anasarca, and was actively dying. To this day, I cannot recall exactly, but I do believe it was renal failure that ultimately led to his death. What I do recall is the distress that his parents were going through during this process with their son.


His father was visibly angry, rarely speaking a word. His mom often appeared worried and frequently crying. One evening, she grabbed my arm and said in a pleading voice, “Why did he do this!?” I did not know what she meant. He certainly did not do anything intentionally to give himself melanoma. The young man opened his eyes and said, “Mom, leave her alone! I am the one that chose to do it. It will help give info to others in the future.” Then it hit me. He must have recently been part of a clinical trial.

I do believe he was part of one of the clinical trials involved in the development of Ipilimumab (Yervoy)--a treatment option for those with metastatic melanoma. Melanoma is the third most common skin cancer, with up to 20% of people developing metastatic disease. Melanoma is one of the fastest growing cancers overall, especially among the younger population. If caught early, surgical excision is curative in most cases. However, those who are at high-risk for developing metastatic disease now have more treatment options available—thanks to this young man.

While Ipilimumab is considered a monoclonal antibody and not a chemotherapy drug, it is not without its own set of side effects. Unfortunately, I have seen one in particular: immune-mediated enterocolitis. I have witnessed this side effect on more than one occasion and it can be quite problematic for the cancer patient.

What we have learned with immunotherapy drugs is that the associated side effects may not be readily apparent upon initiation of treatment. Oftentimes, this is a slow process until a response is seen. In the interim, there may be transient worsening of disease before the disease stabilizes and/or the tumors regress. These types of situations are common, and I have seen them first-hand with ipilimumab.

Two patients in particular come to mind: an avid golfer and a law enforcement professional. The avid golf player had his initial presentation in the tissue surrounding his eye, and after surgical intervention, he lost control of his eye lid. He had lesions throughout his lung, gastrointestinal system, and liver-- Ipilimumab was his decision for treatment. He was tolerating the drug quite well and about halfway through his treatment protocol, a PET scan revealed new metastatic lesions. He decided to continue to move forward with treatment. He had only one treatment left to complete, but unfortunately he had developed diarrhea after the second out of 4 doses, and did not tell anyone until he received his third dose. He said he was determined to complete the entire treatment regimen. He was suffering from immune-mediated enterocolitis and through the use of loperamide, diphenoxylate/atropine (Lomotil), steroids, and treatment delay, his diarrhea finally subsided after 8 weeks. Unfortunately, at the urging of his family, he decided not to take his last treatment. He passed shortly after.

The law enforcement professional had a similar course and also developed diarrhea. He did not tell anyone about it until he had a syncopal episode at home and was found unconscious in the bathroom. He was admitted to the hospital, but instead of only suffering from immune-mediated enterocolitis, he had a perforated bowel. He also was receiving Ipilimumab and starting experiencing side effects halfway through treatment. He decided to go home with hospice care and passed away shortly after. It was unfortunate that these men felt the need to hide the diarrhea they were experiencing. Both of these cases sound like failures, but I do not believe they were because during the time of receiving treatment, both patients and their families were grateful there was a treatment option available, which provided them with hope for a longer life. What has been your experience treating patients with Ipilimumab?

http://www.oncotherapynetwork.com/skin- ... s=21082014

Vicki