First two weeks on NVL-655 clinical trial: Field Research for the Clinical Trials Committee
EDITOR'S NOTE: Jeff Sturm is a Board member, and Medical Committee member at ALK Positive, Inc. and recently enrolled in the Nuvalent clinical trial. He has been kind enough to update our ALK Community on the process and the progress. #StrongerTogether
March 15, 2024
I started on the Phase II NVL-655 trial on March 1st, 2024, at UC Davis’s Sacramento campus, a seventy-five-mile ride from my house. I had pre-registered with Dr. Jonathan Riess’s trial coordinator in December, sending records from my oncologist electronically, and answering a lot of questions. They wanted a record of my initial cancer, and details on the mutations that came up with various progressions, along with all the dates. The current mutational profile was most important to the doctor for qualification to participate. My local oncologist knew Dr. Riess personally, which helped, I think, and having your oncologist touch base with a prospective trial-coordinating doctor can help open the door. I also had testing results from University of Michigan’s organoid drug screening program that gave NVL-655 highest marks for treating my cancer. So, when the trial opened, I actually received a nice note from Chris Turner, Chief Medical Officer of Nuvalent, telling me to make contact, and to let Marc Rosenzweig know as well. Marc has also started NVL-655, three days behind me. The trial opened on February 15th, and I had my first dose on March 1st. Pretty impressive turnaround.
The cancer has spread to my abdomen and has been no picnic at all. I was very sick in February before the trial. But in two weeks, most of the gastrointestinal symptoms have declined. The cancer is still there but the effects are muted considerably, and you can believe I’m grateful about that. I have the G1202R/G1269A double mutation that NVL-655 is apparently designed for, although there are no comprehensive IC50 charts for the drug that I could find. I’ve had some weird neurological effects, like uncomfortable electricity in my skin and occasional stinging spots here and there, so we lowered the dose from 150mg to 100mg, which is somewhat better. I’m super sensitive to TKIs, so I may need to drop it again, which I’m told is a possibility.
I’ve driven up to Sacramento for Thursday/Friday sessions five times since mid-February, staying at the Holiday Inn across the street. We’ve done blood draws every time, and lots of EKGs, twice where I sat in an open infusion room all day for as many as four EKGs over the hours. I’ve met with the Physician’s Assistant and the Trial Coordinator each visit, often twice, and the doctor every time but once. Next week they are doing a “slow blood draw” that shows up on my calendared schedule, that studies the pharmacokinetics (PK), which I presume is the uptake of the drug by my body over time, and perhaps other things. Another few hours in the infusion room are in store, repeatedly for a while. It’s ok to leave and come back for time-scheduled EKGs, the hotel is a block away, and the cafeteria in the hospital has great food. There’s plenty of space on campus to take walks, so EKGs every two hours aren’t so bad. That will be over soon, I think. There are a lot of very sick people in the infusion room, and their travails are the hardest part of the experience to assimilate for me.
The staffers at the UC Davis cancer clinic are invariably gracious and in good humor. Everything flows like clockwork. My appointments so far have occurred on time within a few minutes. The MyChart system works great, and I’ve met with a nutritionist, a palliative care doctor, and a social worker, all of whom have been very helpful. It’s an extremely well-run operation, treating ninety chemo infusion patients a day. Somehow people are not stressed out at all, except for some of the patients, and it’s not at all crowded. There’s a relaxed atmosphere that really seems like an accomplishment for the hospital administrators. Dr. Riess and his team are terrific, and I would choose him as my primary oncologist in a heartbeat. The Physician's Assistant and the Trial Coordinator are very much on the ball and respond very quickly to all kinds of inquiries.
If you are going to consider this trial, please know that you’ll need to be totally committed to the program, and to be prepared to execute all the many instructions. For some of us, NVL-655 will be a lifesaver. There’s something gratifying in knowing that trial participation enables approvals for potentially healing drugs. Yet another way to contribute to the cause, and a very big one, while taking care of yourself free of charge.
Written by: Jeffrey Sturm,
ALK Patient, Board member, and Medical Committee member at ALK Positive, Inc.