Investigator Studies Program (MISP): Letermovir
Effective January 2022, the CMV Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to April 13, 2022. This is a competitive process that will be conducted by the CMV MISP in 2022. 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
- Impact of CMV infection/disease in under-represented solid organ transplant recipients
- E.g., recipients of Asian descent, Black/African Americans, LatinX, Indigenous Peoples
- 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 characterizing the real-world experience of letermovir for CMV prophylaxis in adult R+ allogeneic stem cell transplant populations in China, Middle East, the Asia Pacific region, or Latin America
- Studies understanding the burden of CMV infection/disease and the relationship to a potentially predictive biomarker (such as but not limited to CMV specific CMI) in chronically immunosuppressed patient populations that are not transplant recipients (E.g., persons receiving chronic immunosuppression or biologics)
- 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. o Studies to optimize secondary CMV prophylaxis with letermovir in kidney transplant recipients
- Studies to optimize the re-initiation of CMV prophylaxis with letermovir in the allogeneic HSCT population, i.e., patients who develop Grade 2 or greater GVHD or other medical events that would alter the risk of developing a clinically significant CMV event
- Studies to optimize the management of CMV DNA “blips” in the kidney transplant 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 allogeneic stem cell transplant recipients
- 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:
|Protocol Submission with Detailed Budget Deadline
||April 13, 2022
|MISP-RC Review Meeting
||May 18, 2022
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