Dear prospective investigators,
We are currently accepting proposals requesting “drug only” support for the Pembrolizumab Investigator Initiated Studies Program (IISP). Please be aware that this is a highly competitive process. “Drug only” proposals are reviewed with the same scientific rigor as those requesting funding.
To help to prepare a successful proposal, we are providing the following guidance:
- Please contact your local Regional Medical Scientific Director (RMSD, US only) or country specific liaison for any guidance pertaining to your specific concept prior to its submission, to ensure that it falls within the scope and interest of the Investigator Initiated Studies Program (IISP).
- Carefully review the Areas of Interest (AOI) below. proposals that are not within the scope of these AOIs may be rejected without further review. Occasionally, we receive proposals out of the AOIs that represent "out of the box" thinking and are ultimately of great interest. If you believe this may apply for your proposal, please review with your RMSD or appropriate liaison prior to submission.
- The pembrolizumab Investigator Initiated Studies Program (IISP) is large with numerous approved studies, which include single agent, standard of care systemic therapies, and/or radiation combinations. Please check www.clinicaltrials.gov to ensure similar studies to your proposed proposal are not already approved or ongoing. You may also discuss what may be possibly in development with your RMSD or country specific liaison.
- Please include documentary evidence of successful and timely accrual and publication of investigators’ studies in similar indications where possible. Operational deliverability is carefully considered in our assessment process.
- Combinations with non-MSD agents may be of interest. In such cases, it is the responsibility of the investigator to procure approval for supply of third-party agents, which should be demonstrated with a letter of support. proposals lacking such documentation may be rejected.
- The program encourages young investigators to seek guidance from a mentor in submitting IISP proposals. If working with a mentor please also provide their CV where possible, along with a detailed letter from the mentor describing the mentoring plan and how this IISP will help the investigator meet their career objectives.
- Please note that no MSD investigational pipeline agents are presently available for use in the IIS program and proposals requesting their use will not be considered.
- In addition, please note that proposals with safety as a sole primary endpoint will not be considered.
- proposals for which the primary purpose is translational studies should be directed to our Oncology Translational Studies Program.
- The program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.
Please note that IISPs should not compete with or duplicate any registration trial for pembrolizumab. Additionally, since the dose and schedule for pembrolizumab has been established for multiple cancers, investigation of alternate doses and schedules is of low priority.
For investigators outside of the US, please contact your MSD country liaison for relevant requirements and timelines. Investigators in the US, please follow the submission process detailed below.
*SUBMISSION PROCESS FOR US INVESTIGATORS*:
There are three required components for the application:
- Proposal – please enter the application directly into Visiontracker by completing all required fields as outlined in the Application Guide. The clinical proposal template is available as a guide for completing your application and may be uploaded as an attachment. Please ensure a study schema is included in the appropriate Visiontracker field or is uploaded as an attachment. For preclinical proposals, the preclinical proposal template is required to be uploaded as an attachment.
- For Submission Type, please select Proposal
- For Type of Support, please select Product
- Feasibility Worksheet – please complete the form and upload as an attachment to your application in Visiontracker. Completion is required for all clinical proposal submissions. For less experienced investigators, please complete Section 4 detailing your relevant colleagues’ experience. Please note that fixed character limits have been built into the forms and cannot be exceeded
- Investigator CV – please upload a current CV (within the last two years) as an attachment to your application in Visiontracker
The MSD IISP review is a competitive process. Decisions will be made on the basis of scientific/clinical merit and strategic fit, as well as operational deliverability.
Please be sure to abide by the timelines for this process as outlined below when submitting applications.
The Areas of Interest for Pembrolizumab are as follows:
2023 Areas of Interest for Pembrolizumab
Special Note: Diversity & Inclusion
We seek to foster diverse and inclusive representation within the individual Areas of Interest for each tumor type, and so encourage study concept submissions across our program which:
- Specifically focus on the outcome disparities in underrepresented populations
- Are led by non-academic programs/institutions
- Are conducted in under-represented regions or countries
Critical Activities and Timelines:
- Novel approaches for the administration of pembrolizumab in the home setting
Review of drug only proposals will be handled on a quarterly basis according to the below schedule.
|June 30, 2023
||August 31, 2023
|October 13, 2023
||November 30, 2023