Immunotherapy Clinical Trials During COVID-19

For perspective on the impact of COVID-19 on clinical trials research in the area of immunotherapy, ACCCBuzz spoke with Joanne Riemer, Research Oncology Nurse at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital in Baltimore, Maryland.Joanne is a senior research oncology nurse in the Upper Aero-digestive Team. In January 2011, she was asked to work with the immunology group on a multi-disease study using MDX-1106, which became BMS-936558 and then nivolumab (Opdivo). She was assigned to patients with non-small cell lung cancer, and since that time has been almost exclusively working with immunotherapy clinical trials.

ACCCBuzz: How has the COVID-19 public health emergency affected day-to-day clinical trial operations at Johns Hopkins?

Joanne Riemer: Very early on we were sensitive to the risk that patients were taking [in terms of potential COVID-19 infection]. So it has been challenging to try to weigh out the risk of COVID-19 and severe illness with these devastating cancers. There are a lot of patients that we feel can wait for the treatment—whether that means they miss a dose or they actually come off the study—because we can’t say for certain that the benefits outweigh the risks. We’ve had to have those frank conversations.

Primary investigators are working with the IRB and different trial command centers on a case-by-case basis to determine the best course of action.

As a senior clinical research nurse, what I have been asked to provide is a list of all patients on studies and where they currently are on each one. Have they been on it for years? The IRB and tumor board looked at everybody and where they were [in the study] at that time. For example, someone who may have gotten a lot of benefit [from being on a study] but who we couldn’t say for certain would benefit by staying on the drug for that much longer—maybe that individual would be looked at slightly differently than someone who was in their first cycle of treatment.

Hopkins’ COVID-19 command center has created a 24-hour manned hotline that helps answer any of our questions as staff or assist with the treatment of patients. It's a big operation, but it makes me feel more secure in my role.

ACCCBuzz: Who is having the conversation with patients about their status on a trial?

Joanne Riemer: Primary and sub-investigators are speaking to the patients. If patients have questions, I may contact them and talk with them about having more conversations about this. For patients who are staying on studies, we are calling them the day before treatment to be sure they don’t have any symptoms, to make sure they know they can’t bring a visitor into the center with them, and to make sure they haven’t had any exposure to somebody with COVID-19. We are doing everything we can to protect our patients who are coming in and avoid exposing somebody unnecessarily to someone who might come in and be asymptomatic and actually have COVID-19.

Providers are speaking with patients, nurses are calling them the day before, patients are being met at the doorway to [be screened again]. If there is any suspicion that somebody may be exposed, there is a hospital-wide algorithm in place to deal with that.

ACCCBuzz: Has Johns Hopkins made the decision to close any trials, such as observational studies or registry studies?

Joanne Riemer: Some of our studies that were collecting a lot of samples, specifically for microbiome studies where patients were not necessarily getting a treatment, those studies have been put on hold currently. This is because there was no benefit to the patient directly, and so putting the patients at risk did not make any sense.

ACCCBuzz: Have you had to furlough some of your research study nurses?

Joanne Riemer: That has not happened. But a lot of the nurses that were research nurses, we’re slimming down and deploying those nurses to other areas, including myself.

ACCCBuzz: What area are you moving to?

Joanne Riemer: I will be in ambulatory at the bedside with the patients who are coming in.

ACCCBuzz: When is that happening?

Joanne Riemer: It is happening now. We’re in the re-orientation phase and doing any competencies needed. That is happening as we speak. There are additional roles that have been created for screening the staff to make sure we are doing everything we can to prevent any infection. There are safety officers. Lots of people at the doors. People making phone calls to patients ahead of time. So the deployment may not necessarily be full-time, but on an as-needed basis.

ACCCBuzz: Is this driven by the need for more providers and clinicians on the front lines?

Joanne Riemer: I think it’s in preparation for that possibility. I don’t think we’re there yet, but we want to be prepared in case it is needed. It’s sad but necessary.

ACCCBuzz: Turning back to immunotherapy clinical trials, have there been resources developed to help distinguish immune-related adverse events (irAEs) from potential COVID-19 symptoms?

Joanne Riemer: Yes, Dr. Jaruska Naidoo worked on an algorithm for us on pneumonitis versus COVID-19 symptoms, calling out that so many things may seem similar but, for example, generally with pneumonitis you won’t have these high fevers. Dr. Naidoo created another layer for us when we are evaluating patients with pneumonitis—which is already difficult to distinguish from pneumonia or other illness—but it’s one more layer we need to look at when patients come in with cough, shortness of breath, or chest pain. We have an immunotherapy-related Toxicity Team that our providers can call on. We are still having people come to us with complaints of pneumonitis, and we have to remember: Has this person been tested for COVID-19? Where does that happen in this process? Are we highly suspicious?

Another challenge in the context of the current COVID-19 emergency is that normally we might recommend that patients get a bronchoscopy because we think they have immune-related toxicity. But now we have to consider whether the bronchoscopy suite is going to be open to this. In response to COVID-19, there have been a lot of changes in these respiratory procedures and surgeries because we are concerned about exposing both patients and staff.

ACCCBuzz: Have you seen a big uptick in calls from worried patients?

Joanne Riemer: I don’t think we are seeing more. In fact, if anything, we expected that our population would be pretty significantly impacted—more susceptible than the general population—and I don’t believe that’s what we are seeing, at least locally. It may be that our patients are that much more vigilant about avoiding people who are sick.

ACCCBuzz: Or possibly don’t want to come into the hospital?

Joanne Riemer: I think most of our patients if they have the opportunity to come in, they want to come in. They want to stay the course [of the clinical trial], and they are afraid of losing ground.

ACCCBuzz: How are you using telehealth in the research areas?

Joanne Riemer: We are doing videoconferencing with patients ahead of time. I have still been seeing patients, but we are wearing masks whenever we see them. A lot of providers, and some of the nurses, are videoconferencing. This is for follow-up with already existing patients.

Videoconferencing has been built into our MyChart, so patients can talk to us through their phone or even through FaceTime or a similar technology if they’ve signed a consent for that. We’re trying to make it as easy as we can and decrease that face-to-face time as much as we can. Keeping that six-foot spacing for appropriate physical distancing is essential.

ACCCBuzz: How has that been going with patients? Are they fairly adaptable to telehealth options?

Joanne Riemer: We had a little difficulty technology-wise initially. Some patients’ phones made it difficult for them to download the software. We usually try to talk patients through the process the day before they are scheduled for videoconferences with providers so the process will go smoothly.

ACCCBuzz: Have there been any challenges with older adult patients in terms of adjusting to telehealth?

Joanne Riemer: Some patients are elderly, and they have managed. If they can’t, then it becomes a phone conversation.

Another challenge is that our patients come from different states, and providers can only practice in states that they are licensed in. There have been waivers from some states. In others, you can make a telephone call, but not hold a videoconference. It does make a difference which state the patient lives in.

ACCCBuzz: Given the stress of worrying about COVID-19 on top of everything else, are you finding that patients on clinical trials are needing more emotional support at this time?

Joanne Riemer: I think they give me more morale. They are all very supportive of the nurses. Whatever they can do to make my job easier, they are trying to do. I think people in times like this are just really humbled, and they seem to want to help as much as they can.

ACCCBuzz: Do you have advice for providers in the community treating patients with immunotherapy?

Joanne Riemer: I think we’re all in this together, and we are all learning together. We’re all getting information on COVID-19 simultaneously. I think looking to our colleagues in New York who are dealing with this in the peak will be very helpful. We’ve heard from our colleagues in Europe. I think we are all learning from each other.

For resources on COVID-19 as it applies to the oncology community, visit ACCC’s continually updated Coronavirus Resource page. ACCC members can also access ACCCExchange, a forum that allows them to communicate in real time with their colleagues about how the COVID-19 virus is affecting their communities and their patients.