Oncology Investigator Initiated Studies Program (IISP)
To advance science and improve patient care by supporting, through the provision of drug/vaccine and/or total/partial funding, high-quality research that is initiated, designed, implemented and sponsored by external investigators. Results will be generated and properly disseminated in peer-reviewed publications.
Pembrolizumab Quarterly Drug Only Review Cycle

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 Research 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 complete the proposal template and submit to Visiontracker with your updated CV by the deadlines below for consideration.

The Proposal Template for clinical studies can be found here.

The Areas of Interest for Pembrolizumab are as follows:

Critical Activities and Timelines:
Review of drug only proposals will be handled on a quarterly basis according to the below schedule.
Submission Deadline Review Meeting Expected Decision
December 31, 2021 January 2022 February 2022
March 31, 2022 April 2022 May 2022
June 30, 2022 July 2022 August 2022
September 30, 2022 October 2022 November 2022
December 31, 2022 January 2023 February 2023
MISP Oncology Contact Information
To learn more or to ask a question, please contact the appropriate MSD Business Development and Licensing contact for your region.