Physician Survey to Assess the Effectiveness of the Additional Risk Minimisation Measures (aRMM) for KIMMTRAK® (tebentafusp) (IMCR-0001)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/107980
• EU PAS number:
  EUPAS107979
• Study ID:
  107980
• Official title and acronym:
  Physician Survey to Assess the Effectiveness of the Additional Risk Minimisation Measures (aRMM) for KIMMTRAK® (tebentafusp) (IMCR-0001)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  France

  Germany

  Italy

  Poland
• Study description:
  The aRMM for KIMMTRAK include a Treatment Guide for Healthcare Professionals and a Patient Guide. These materials are distributed to all physicians who are expected to prescribe KIMMTRAK. The purpose of the Treatment Guide for Healthcare Professionals is to highlight the key measures for minimising the severity of cytokine release syndrome (CRS) associated with KIMMTRAK use. Healthcare professionals are required to provide the Patient Guide to patients when KIMMTRAK is prescribed in order that patients are informed as to what to expect following their KIMMTRAK infusion. The proposed assessment will evaluate the physicians’ understanding of the important safety information in the Treatment Guide for Healthcare Professionals and whether healthcare professionals are providing patients with the Patient Guide.
• Study status:
  Ongoing

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Actual: 08/08/2023

Study start date

Actual: 05/12/2023

Date of final study report

Planned: 15/06/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Immunocore Ireland Ltd.

Study protocol

Initial protocol

Physician_survey_Kimmtrak_RMP_v_3.0_09Nov2023

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)