Mets Day 1048: Swollen nodes

Today I had a follow-up appointment with Dr. Hahn at Johns Hopkins. He fondled the nodes on the left side of my neck and agreed that they appeared to have grown in size in the past week. He said that the objective of the nivolumab PD-1 drug was to "rev up" the body's immune system and hopefully get it to attack my metastatic cancer. Swelling around the tumors in my shoulder and neck is a sign that the drug is doing what it's supposed to do. Or it's a sign that my cancer has shifted into high gear and is growing faster than ever before. Dr. Hahn said that there was no way to know at this point which one it was, although he preferred to think the enlarged nodes were because the immunotherapy drug working as intended.

I will continue to get nivolumab infusions every other week for at least the next 12 weeks. To determine if the nivolumab is working, I will have a CT scan on March 24, and another 6 weeks later. A team of about 5 doctors will closely compare those scans to my baseline scan of February 10, as well as my earlier NIH scans. If the size of the tumors has decreased, or is stable, then I will keep going with the infusions. If the tumor size has increased by more than 25% from the baseline, then we will have determined that nivolumab does not work on my metastatic cancer, and I will be released from the trial. In that event, I'd be free to pursue other therapies, such as Dr. Apolo's cabozanatib trial, or another second-line therapy, such as a taxene.

I asked Dr. Hahn whether surgery or radiation might be an option in the future. He said that most doctors would not favor surgery to remove tumors in lymph nodes, because such surgery is not curative, carries its own risks, and would not improve my quality of life. He said that radiation therapy might be an option if the nodes were impacting my nerves or blood flow, or causing excessive pain. Pursuing that would mean that I would have to first drop out of the trial. I'll give the nivolumab time to work, but will continue to educate myself regarding my options.

I told Dr. Hahn that one of the consequences of the swollen nodes was that I had a constant dull ache on the left side of my neck, running from the bottom of my jaw, down my neck, and running along the top of my shoulder. My left clavicle is being pressed up by the tumor underneath it. Another tumor at the base of my neck is pressing down on my clavicle. And the two other tumors in my neck are pressing my skin out. Dr. Hahn said that any pain could be managed with painkillers, but I'm not close to that point yet. It just feels like a pulled muscle.

I also have recently developed a pain on the left side of my abdomen, which also feels like a pulled muscle. The scans did not show anything unusual going on there, so neither I nor Dr. Hahn could say what it was. Again, it's not a debilitating pain - no more than 2 on the zero to 10 pain scale - just enough to let me know that it's there.

Fortunately, I have so far avoided any of the other side effects of the nivolumab trials - no constipation or diarrhea or joint pain or anything else that I have noticed. I'll continue to carefully monitor my status, and will report to Hopkins next Tuesday for my next infusion.

Mets Day 1041: First Opdivo infusion

I was supposed to be at Johns Hopkins at 7 am this morning for my first infusion on the nivolumab (Opdivo) clinical trial. The most exciting part of the day was getting up there. It started snowing the night before, and the forecast was calling for 5-10 inches, which for the DC area is enough to shut down the city. I planned on driving the Jeep Wrangler. For some reason, I did not sleep well, and at 4 am decided to get up. I plowed the driveway, cleaned off the hot tub, then enjoyed a pre-dawn soak. I was on the road by 5 am. Our gravel road was unplowed, but the Jeep had no problems. The paved roads were mostly plowed but snowpacked. The beltway and I-95 was snowpacked, with lanes invisible. Fortunately, there was little traffic at that hour.

I arrived at JHU just before 7 am, and from that point on, everything went smoothly. My port was accessed, and the nurse took 17 vials of blood (I did agree to this experiment, I reminded myself). I met with Dr. Hahn and the clinical trial nurse, then was told to get some breakfast while the pharmacy prepared the right mixture of nivolumab, since dosage is custom-tailored to each patient's weight the day of treatment.

The JHU infusion room is older and more crowded than GW's infusion room, where I did my two prior chemo regimens. I planned to close my eyes and rest during the infusion, but the first chair that I was placed in would not stay reclined. I asked to be moved to another chair, and that one reclined so far it felt like my feet were higher than my head. But it did the trick. The actual infusion took only about 60 minutes.

While the PD-1 drug was being pumped into my body, the nurse told me that they had been getting some remarkable results from these new immunotherapy drugs. He also told me to make sure that I immediately reported anything different - hives, rashes, difficulty in breathing, tingling, changes in the GI tract, telepathy, etc. Listen to my body, I was told. Hopefully, the side effects should be minimal.

I was back on the road by noon, and by then the roads were all clear. I came home and took a nap - not because of the infusion, but because I had not slept much the night before. Jennifer and I went over to some friends for Pancake Day dinner.  I'm yawning as I type this, so I'm going to listen to my body and go to bed.

Mets Day 1040: I'm in the nivolumab-only cohort

I received an email from the clinical trial nurse at Johns Hopkins, advising me that, for the clinical trial in which I am enrolled (A Phase 1/2, Open-label Study of Nivolumab Monotherapy or Nivolumab Combined With Ipilimumab in Subjects With Advanced or Metastatic Solid Tumors), I have been randomized into Arm N. This means that I will only receive the Nivolumab (Opdivo) anti-PD-1 drug, and will not get ipilimumab. The infusions will be every other week. I will get 3mg of nivolumab per kilogram of my body weight. I get my first infusion tomorrow morning.

I'm very pleased about this news. I very much wanted to get a PD-1 or PD-L1 drug and was not that eager to get ipilimumab along with it. Ipilimumab has more side effects, and has not been shown to have a great impact on metastatic bladder cancer. I'm hopeful that there will be very few side effects from nivolumab only. 

I will need to juggle some of my travel plans around the schedule, however. In early March, Spencer and I are going to Utah to visit Rose and her parents, and depending upon how I feel, maybe do some skiing. I won't have to make any changes to that trip, it appears. But in late March, Jennifer, Kirsten, and Garrett and I are booked to fly to Florida to visit my folks over spring break. I'll have to push back my departure by two days to get my infusion. And in May, I am planning to fly out to Utah for my niece's wedding, and the birth of grandbaby #2. I'll have to shorten that trip. That's why I fly on Southwest - no cancellation fees and easy rebooking. It turns out that the new flight dates are even cheaper than the tickets I had already purchased, so happy day!

Today I saw an abstract of a recent article about the management of metastatic bladder cancer from a French medical journal, La Revue du Praticien. The abstract bluntly summarizes the current status of treatment of metastatic bladder cancer:

The management of patients with metastatic bladder cancer is mainly based on cytotoxic chemotherapy. The reference molecule is cisplatin. In 2014, first-line regimens include gemcitabine and cisplatin (GC protocol) or methotrexate, vinblastine, and cisplatin doxorubicin (MVAC protocol). When cisplatin is contra-indicated, another platinum salt, carboplatin, is used in combination with gemcitabine. Vinflunine is the only molecule to have obtained a marketing approval for patients who failed first-line chemotherapy including a platinum salt. The overall prognosis of patients remains dismal, since the median overall survival is 12 to 14 months for patients being treated with cisplatin, whereas it is less than 1 year for patients receiving carboplatin. The identification of new effective drugs is a major challenge for the coming years.

I'm two months away from my third anniversary of the discovery that my bladder cancer had metastasized, so I am well past the median survival point. I'm aware than it has been more than 20 years since the FDA has approved a new drug for the treatment of bladder cancer, and I'm hopeful that nivolumab is one of the "effective new drugs" that the article says will be a "major challenge" to identify. 

Mets Day 1037: Disability insurance stories

More than 15 years ago, when I was practicing intellectual property law full time as a partner at a big DC firm, I had a meeting with my insurance agent, Dave Morris. He specialized in counseling partners at big law firms regarding life and disability insurance. Many big law firms require their partners to carry a type of "key man" life insurance, payable to the firm in the event of accidental death. This agent offered such policies to law firms, and also offered additional types of insurance to individual partners. Dave is an independent agent, so could shop around and offer policies from multiple insurance companies.

Dave proposed that I consider purchasing a type of disability insurance called "own occupation disability income replacement insurance." He explained that, with this type of insurance, if ever I was to suffer a disability that would preclude me from making a living doing what I was doing (e.g., first chair patent trial lawyer), then the insurance would kick in to provide for my family. I would not be required to take a lower-paying job or change my occupation: if I could not continue doing my own very specific occupation due to my disability, then the insurance would pay out. And because I was paying for the insurance out of my own pocket with after-tax dollars, any insurance proceeds would be tax-free. (This article from Motley Fool discusses private disability insurance in more detail.)

I thought about it for a while, and did some research. I learned that the odds of having a disability were greater than an accidental death, and yet I hadn't hesitated to purchase life insurance. I decided to sign up for the own occupation disability income replacement insurance. Over time, during our annual insurance reviews, Dave presented opportunities to purchase additional coverage. Sometimes I added coverage, and sometimes I declined. I understood that the best kind of insurance was the kind I never needed. But we buy it for a reason: to provide an economic aid in time of need.

(In November 2011, I purchased long-term disability insurance for Jennifer and myself, which would pay $200/day in the event that either or both of us could not perform two or more of the five defined activities of daily living. A week after I signed those applications, I saw blood in my urine, which started me down the rabbit hole of bladder cancer. But this post isn't about long-term disability insurance - it's about my experience with own occupation disability income replacement insurance.)

After I was diagnosed, I kept on working. I kept working along through my neoadjuvant chemotherapy.  I planned to keep working after I recovered from my radical cystectomy, when my bladder and prostate was removed, and neobladder was built. I began to reconsider that plan when my cancer was found to have spread into my lymphatic system. Nevertheless, I tried to come back to work after my surgery, even leading a three-week long patent trial in late 2012. But my neobladder continued to leak at night no matter what I did. With every leak, I would bolt upright in bed (something about the proximity of a nerve to my rearranged urethra), and I would be unable to go back to sleep. After months of battling sleep deprivation, together with battling metastatic cancer, I found that I was unable to continue in my career with the same level of excellence and dedication as before.

Under my law firm's partnership agreement, a partner who becomes disabled will be paid for at least the rest of the calendar year at the same amount as if he had been working for the year. It was a kind of short term income replacement insurance. So for 2012, I did not suffer any loss in compensation, even though I worked less than half of the year.

Near the end of 2012, I submitted disability applications to the two insurance companies (Unum and MetLife) that underwrote the four own occupation disability income replacement insurance policies that I had purchased. I documented my cancer journey to date, mailed more than a foot-thick stack of medical records, provided copies of earnings records and tax returns, and gathered letters from my doctors and my work. I had long phone conferences with claims examiners. Dave (the insurance agent) and my law firm supported my application. The process was not acrimonious in any way - all of the insurance company employees were unfailingly courteous, professional, and sympathetic. Eventually, both companies agreed that I met the policy requirements for own occupation disability coverage. Even though I might have been able to work at least part time doing something other than first chair trial work, that was not relevant to whether the policies would pay out. The insurance companies began to pay out as required by insurance contracts. One of my policies even required the insurance company to make contributions to a retirement plan, since I would no longer be doing that.

The policies all provided that, as long as my ongoing earnings are less 20% of my pre-disability earnings, then I am classified as "totally disabled," and will be paid 100% of my monthly benefit. Any dollar that I am paid over that 20% limit would result in a dollar-for-dollar reduction of insurance benefit. Because my insurance benefits are not taxed, and the way the offsets work, it turns out that there is no economic incentive to work (and earn) anything less than 65% of my pre-disability earnings. In other words, assuming I was able, if I was to go back to working half-time (and being paid half of my pre-disability income), I would actually be netting less than if I was being working (and being paid) 20% of my pre-disability income.

My law firm and I agreed that, beginning in 2013, I would continue as an equity partner, but would be paid a flat amount equal to about 15% of my pre-disability income. I have a substantial amount of deductions from that flat payment, including various professional expenses, life insurance, and health insurance. (As as a partner, or co-owner, there is no employer contribution for health insurance. I pay 100% of the cost for family health insurance overage, which runs in excess of $20,000 per year). 

Between the private disability insurance payments and the ongoing income from my firm, all of my family's financial needs are being met. I have been profoundly grateful that I acted on my insurance agent's advice to purchase own occupation disability income replacement insurance. I have been relieved of the need to continue to work to provide for my family, giving me extra time to enjoy my remaining days on earth.

There have been some hiccups and kinks in the process of continuing to receive payments under my own occupation disability income replacement insurance policies, however. MetLife insists that it is unable to make electronic deposits, but must mail a live check each month. Unum initially agreed to "conditionally" make payments under my policy, reserving the right to change its mind. After I and my agent pressed Unum for why it was reserving its rights, it agreed to withdraw the conditional designation. Early on, the MetLife claims administrator was interested in whether I was participating in vocational rehabilitation. It took several conversations with the claims administrator, and the intervention of my insurance agent with some of the MetLife higher-ups, for MetLife to figure out that whether or not I was participating in vocational rehabilitation was utterly irrelevant to whether it should be paying out under my policies. And it took MetLife more than six months to begin investing my "new" retirement savings into the mutual finds that I had selected, thereby missing a significant amount of gains.

The events that triggered this blog post started last fall, when Unum sent me a letter claiming that I had been overpaid by about $14,500 in 2013. In a later phone conversation and letter, the Unum claims administrator told me that she and one of their in-house actuaries had reviewed my 2013 K1 from my law firm and had determined that in 2013 I had been paid about $2000 over the 20% threshold of pre-disability earnings. I was sent the calculations, which I reviewed, but which made no sense to me. Unum said it would start withholding 25% of its monthly payments until the $14,500 was recouped. After some digging, I determined that apparently what put me over the 20% threshold was the fact that my 2013 K1 erroneously included in my overall compensation the cost for a reserved parking place at my downtown office (about $2500 - parking is expensive in DC), even though I had given that up in 2012. Despite explaining and providing additional documentation to Unum about the cost of parking in DC, I was unable to persuade the Unum claims administrator to change her mind. (To this day, even if Unum was right, I do not understand how my getting paid $2000 over the 20% threshold meant that I was overpaid $14,500 in a year.)  Frustrated, I forwarded the letters and calculations to my insurance agent, Dave, who agreed to press my case. To his great credit, he continued to persist, eventually raising this issue with Unum's senior management.

Today I received a letter from Unum. It stated that Unum had reversed the decision to recoup $14,500 from my 2013 payments. In addition, the letter stated that, in reviewing my claims payments, Unum had determined that it improperly delayed making payments under my policy, and that I should be paid an additional $25,000, plus $500 in accrued interest. I checked, and found that yesterday Unum made a $40,000 direct deposit to my bank account. Go figure!

I told Jennifer about this, and she said, "Woo-hoo! Where do you want to go on vacation?" (Instead, I've used the money to pay down our HELOC.) Each of the kids laughed and thought it was a great turnaround. This story reinforces what my firm's insurance practice group tells clients: the denial letter from the insurance company is never the end of the matter, but is only the beginning. The moral: when an insurance company says no, don't give up. Keep pressing. Get someone to help make your case. You never know how things might turn out.

Mets Day 1036: CT scan shows more neck tumors

Today I received the results of Tuesday's CT scan at Johns Hopkins. The good news: no tumors were detected in my abdomen, pelvis, organs, bones, or brain. In addition, the supraclavicular node is 2.5 cm, basically unchanged in size from my January 8, 2015 scan. The bad news: three other nodes in my neck have swelled in size. In the technical language of the radiologist:

There is an enlarged level 5 posterior triangle lymph node seen best on series 6 slice 52 measuring 2 cm on the left side. An additional level 5 A lymph node measuring 1.9 cm on the left side is present. Additional posterior triangle level 5 B lymph nodes are seen in the left neck and there is a 3 cm left level 4 lymph node behind the jugular vein and lateral to the carotid artery on the left side anterior to the anterior scalene muscle.

The reference to levels refers to the location in my neck (see this chart), and does not characterize the nature of the cancer.

For the past couple of weeks, I have noticed that, each morning when I awake, the left side of my neck is somewhat sore. Each time I move my neck, I feel a little bit of pressure on the left side. But so far, this cluster of tumors is not interfering with any bodily functions. I have no nerve pain, or difficulty in talking, or chewing, or swallowing, or moving my neck. The tumors apparently not compressing my jugular vein or carotid artery, or otherwise interfering with blood flow to my head (probably because I've been brain dead for decades, as my kids might say). But this is the first time that I have started noticing the direct effects of my cancer, as opposed to the side effects of all of the treatments of my cancer. It's not a comforting feeling.

On Tuesday, as Dr. Hahn palpitated the nodes in my neck, I asked him if there was anything that should be done about my growing nodes, other than the clinical trial we were discussing. He said no -- radiation was premature, since they were not interfering with any bodily functions. Surgery probably was not advised, since taking out the nodes would not be curative, and surgery would have its own risks and complications. So I watch and wait for protrusions to sprout from my neck, just as Dr. Frankenstein predicted: "For the experiment to be a success, all of the body parts must be enlarged." 

Mets Day 1034: I'm joining the nivolumab trial

For the past two weeks I have been doing a lot of follow-up research on the best clinical trial for me. On Friday, January 30, I met with Dr. Alex Spira at Inova Fairfax. I had previously spoken with his clinical trial nurse, which evolved into several email exchanges. Eventually she realized that the technical and detailed nature of my questions put me outside the realm of most patients, and she forwarded my emails to Dr. Spira for direct response. He told me that the MPDL-3280a trial he was running was closed to patients like me who had previous platinum-based chemotherapy. He nonetheless offered to meet with me and evaluate other clinical trial options. When we met, he reviewed my clinical trial options, and recommended that I pursue the nivolumab trial at Hopkins. He said that a PD-1 or PD-L1 drug was probably the most promising option at this point. He also offered to keep following me and be available if I had further questions, which I appreciated.

On Monday, February 2, I came across a recent article in Lancet Oncology said that MPDL3280a worked best in patients with PD-L1-positive tumor-infiltrating immune cells. I also did some research on Foundation Medicine, and their cancer genome testing program. I sent emails to Drs. Apolo and Aragon-Ching, asking whether my tumor tested had been tested for that characteristic, and if so, whether it should influence the trial I should join. Dr. Apolo responded that, when NIH did the sequencing of my cancer, they did not test whether my immune cells were PD-L1-positive. In a later conversation, she explained that there was a lot of debate in the cancer research community over how to measure for PD-L1-positive characteristics: was it 1% of all cells, or 5% of all cells, or more? In addition, she said that researchers were learning that PD-L1 expression was not an immutable static trait, but could vary over time, and was not fully understood. She urged me to go ahead with a PD-1 or PD-L1 trial regardless of whether my tumor had been tested for that characteristic, because it was one of the trials that showed great promise.

(What is the difference between PD-1 and PD-L1?  "PD" stands for Programmed Death. As I understand it, PD-1 is an inhibitory T-cell co-receptor - a type of protein - that negatively regulates T cell responses. PD-L1 is a ligand of the PD-1 protein that is expressed on the tumor. The theory is that interactions between PD-1 and the PD-L1 ligand can lead to antitumor immune suppression. The PD immunotherapy drugs in development are designed to engage PD-1 on effector T cells, allowing T cells to fight cancer. Scientists are still trying to figure out which type of tumors respond best to PD drugs, as well as figuring out the proper dosages without causing unacceptable side effects on the patient. That's what these trials are for.)

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions between PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in development are designed to interrupt those interactions, allowing T cells to fight cancer. - See more at: http://www.onclive.com/conference-coverage/nyl-2013/PD-1-and-PD-L1-Inhibitors-Expected-to-Change-the-Landscape-of-Lung-Cancer-Treatment#sthash.nfZRBoJ5.dpuf

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions between PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in development are designed to interrupt those interactions, allowing T cells to fight cancer. - See more at: http://www.onclive.com/conference-coverage/nyl-2013/PD-1-and-PD-L1-Inhibitors-Expected-to-Change-the-Landscape-of-Lung-Cancer-Treatment#sthash.nfZRBoJ5.dpu

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions between PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in development are designed to interrupt those interactions, allowing T cells to fight cancer. - See more at: http://www.onclive.com/conference-coverage/nyl-2013/PD-1-and-PD-L1-Inhibitors-Expected-to-Change-the-Landscape-of-Lung-Cancer-Treatment#sthash.nfZRBoJ5.dpuf

PD-1, an inhibitory T-cell co-receptor, or PD-L1, a ligand expressed on the tumor. It is thought that interactions between PD-1 and the ligands PD-L1 or PD-L2 can lead to antitumor immune suppression; the compounds in development are designed to interrupt those interactions, allowing T cells to fight cancer. - See more at: http://www.onclive.com/conference-coverage/nyl-2013/PD-1-and-PD-L1-Inhibitors-Expected-to-Change-the-Landscape-of-Lung-Cancer-Treatment#sthash.nfZRBoJ5.dpuf

Anyway, Dr. Aragon-Ching responded to my email of last week saying that Dr. Spira had told her that he was going to request that my tumor samples be sent to Foundation Medicine for testing, and that I should check with him. I didn't recall discussing that with him on Friday, so I emailed him to find out. He responded in minutes, saying that even before we met, he had requested that my tissue on file at NIH be sent to Foundation Medicine. He said it would take several weeks to get results. I thanked him for his proactivity.

On Tuesday, February 3, the clinical trial nurse from Johns Hopkins called me to set up an appointment with her and the doctors participating in the trial. She invited me to meet with her on Thursday to review the trial forms and answer my questions. We spent more than an hour talking about the trial. She confirmed that I met the clinical trial eligibility guidelines. She also said that the Phase I nivolumab-only cohort was closed, but that the Phase II trial was open. There are two cohorts in the Phase II trial; the first cohort gets 3 mg nivolumab and 1 mg ipilimumab every 3 weeks for 4 rounds, then 3 mg nivolumab only every other week thereafter. The second cohort gets 1 mg nivolumab and 3 mg ipilimumab every 3 weeks for 4 rounds, then 3 mg nivolumab only every other week thereafter. In either cohort, I'd get the nivolumab drug. Patients are randomized into each cohort, and they know which cohort they are in. She thought that I might want to wait for the Foundation Medicine DNA test results before making the final decision to enter her trial (or any other trial, for that matter). She is tentatively holding a place for me. I have a meeting scheduled with Dr. Noah Hahn next Tuesday. Should I enroll the nivolumab trial, he would coordinate my care with Dr. Dung Le, the principal investigator.

I sent Drs. Apolo and Aragon-Ching summaries of this news, and asked whether the different dosages of ipilimumab might put me at greater risk of side effects, given that I had two prior rounds of cheno. They both responded that the risks should be manageable, especially in light of my overall absence of co-morbidities and low tumor burden. Both endorsed the idea that I participate in that trial.

Last Friday, Memorial Sloan Kettering called to schedule an appointment for their nivolumab trial. I told the scheduler that I was already deep into discussions with Hopkins about the same trial. Keep us in mind in the future, they said. 

Last weekend, I did more research on nivolumab. According to the NCI drug dictionary, nivolumab is

A fully human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1/PCD-1) with immunopotentiation activity. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands PD-L1 and PD-L2, resulting in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and effector function through the suppression of P13k/Akt pathway activation.

I learned that, in December 2104, the FDA gave approval to Bristol-Myers Squibb (BMS) for nivolumab for treatment of unresectable or metastatic melanoma. BMS's brand name for nivolumab is Opdivo. The FDA press release stated that

Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking melanoma tumors. Opdivo is intended for patients who have been previously treated with ipilimumab and, for melanoma patients whose tumors express a gene mutation called BRAF V600, for use after treatment with ipilimumab and a BRAF inhibitor.

BMS's January 27, 2015 release of its fourth quarter and full year 2014 results trumpeted its successes with Opdivo. BMS apparently is spending more than $100 million in different Opdivo clinical trials. Some biotech stock analysts think that Opdivo is going to be a blockbuster drug for BMS, with 2020 sales projected to be more than $7 billion. Big pharma indeed.

Today I went back up to Hopkins and met with Dr. Noah Hahn, head of Hopkins' urologic oncology group. He joined JHU last April from Indiana University, and looks to be another great advisor. Assuming I enroll into the trial, he would be personally following my case.  He seemed excited to work with a younger patient with few co-morbidities and low tumor burden -- he said that most of his patients were in their mid-70s or older and that many were battling other complications in addition to cancer. I had the required screening CT scan, EKG, and blood work. I also met again with the clinical trial nurse, who told me that she would submit my application to join the trial. She said that she expected me to be accepted by BMS with no problems. She would then be advised by BMS into which cohort I had been randomized. She said that she could work with me on scheduling my visits, as I am supposed to be in Utah early next month for a granddaughter visit, then in late March to Florida to visit my folks.

I feel good about this trial. As a result of my research, I have 4 well-respected oncologists endorsing my decision. I realize that the odds are low that I will have a complete response (e.g., all tumors shrinking to below pathological level). The odds are somewhat greater that I will have a partial response (e.g., more than 20% tumor shrinkage, but not a complete response), or stable disease (e.g., less than 20% shrinkage or growth). But there is also a 50% or more chance that my tumors will not respond, and keep growing. There is not enough data about nivolumab to show long-term results, and no one is expecting it to be a "cure" (e.g., complete response and no subsequent tumor development for 5 years). But this trial seems to be the right therapy at the right time.