Investigator Studies Program (MISP): Letermovir

Effective December 2022, the CMV Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to May 5, 2023. This is a competitive process that will be conducted by the CMV MISP in 2023. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below. The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.

The following areas are of interest to Investigator Studies Program Committee

Clinical Non-interventional:

• Studies that characterize the relationship between induction and/or maintenance immunosuppression strategies and the burden of CMV infection/disease with an emphasis on the potential utility of predicting events with CMV specific CMI in kidney transplant recipients
• Studies that characterize the relationship and clinical impact of treatment of acute rejection and CMV infection/disease in kidney transplant recipients where biomarkers such as CMV specific CMI are studied as a potential predictor of a CMV event.
• Studies to characterize the burden and clinical/economic outcomes of CMV resistance in SOT recipients receiving prophylaxis or treatment for CMV
• Studies to characterize the difference in early versus late initiation of CMV prophylaxis post HSCT with Letermovir
• Studies to evaluate the Pharmacokinetics of Letermovir in patients with severe renal insufficiency (e.g. subjects with CrCl<15mL/min or in Kidney Transplant recipients requiring short term hemodialysis)
• Studies that compare LET vs VGCV for CMV prophylaxis in the D+/R- Kidney Transplant population on one or more of the following outcomes:
• Management strategies 9e.g., dose adjustments, management of other immunosuppressants)
• Clinical correlates, including but not limited to effectiveness, CMV viremia, CMV resistance
• Healthcare resource utilization and costs

Clinical Interventional:

• Studies to optimize CMV specific prophylaxis strategies in immunocompromised patients utilizing CMV specific CMI or other biomarkers to guide the initiation and duration of Letermovir prophylaxis.


• Studies to optimize CMV prophylaxis with Letermovir in kidney transplant recipients following a CMV event (CMV infection or disease)
• Studies to define and optimize the management of CMV DNA “blips” in the kidney transpant population

• Studies that evaluate the potential role of Letermovir in preventing CMV infection/disease in patient populations at moderate risk for reactivation and may include assessment of healthcare resource utilization.


• D+/R+ and D-/R+ adult solid organ transplant recipient

Please complete a protocol with detailed budget via Visiontracker, the Company's on-line study management system (in US). The protocols will be collectively reviewed and selected by the CMV MISP Committee.

Critical Activities and Timelines:

Activity	Review Cycle
Protocol Submission with Detailed Budget Deadline	May 5, 2023
MISP-RC Review Meeting	May 24, 2023

MISP Information
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator Studies Program should contact their local MSD office.