Immune Checkpoint Inhibitors in Thoracic Transplant Recipients Registry

(ICI Transplant Registry) 

About the Registry

The ICI Transplant Registry is a registry intended to enroll and follow heart or lung transplant patients who developed malignancy and received treatment with Immune Checkpoint Inhibitor therapy (ICI). This international multi-institutional registry is open to participation by transplant centers and cancer treatment centers worldwide that wish to participate. 

ICIs represent a novel immune therapy for malignancy refractory to other forms of treatment. Yet, solid organ transplant recipients have been excluded from clinical trials of ICIs and ICI safety in this population has not been established. ICIs are associated with immune-related adverse events, and rapid and severe allograft rejection has been reported after ICI initiation in some transplant recipients.  

Registry Goals

The primary goal of the ICI Transplant Registry is to determine how to best use ICIs in in survivors of heart or lung transplantation with cancers refractory to traditional interventions, and how to treat immune-related complications in these patients if they develop. Specifically, we are interested in answering these questions: 

1. Which patient characteristics predict a favorable or unfavorable response to use of ICI? These factors may not be aligned from the transplant and cancer treatment standpoint.
2. Is the mechanism of graft injury in transplanted organs the same as ICI-induced myocarditis?
3. Would specific background immunosuppression adjustments minimize adverse outcomes from ICI use? As an example, since high-dose steroids are believed to alleviate ICI-mediated myocarditis, could background steroid therapy decrease risk of graft dysfunction?
4. What transplant-specific testing and surveillance should be done during ICI therapy? Could monitoring of serum troponin-I or cell-free DNA provide information on graft injury risk?
5. Are there other adjunctive interventions to mitigate the risk associated with ICI treatment?
6. What is the optimal treatment strategy for transplant patients that do develop graft dysfunction? 

 How to Join

The ICI Transplant Registry welcomes participation of centers that have treated heart or lung transplant recipients with ICIs for malignancy. The following documents will be provided to the participants upon request:

Registry site enrollment documents

Data field forms

Template regulatory compliance documents
 

Registry administrative contact:
Alfonso Siu
alfonso.siu@hsc.utah.edu
Tel: 801-213-8601
 

Registry principal investigator:
Josef Stehlik, MD, MPH
Josef.Stehlik@hsc.utah.edu
University of Utah Health, Division of Cardiovascular Medicine
50 N Medical Dr., 4A100 SOM, Salt Lake City, UT 84132
Tel: 801-585-2340,