Public trial registry of the CCC-Munich

Trial Keynote-158 // MK3475-158

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
Keynote-158 // MK3475-158
World
Full title
:

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects with Advanced Solid Tumors (KEYNOTE 158) Tumor Types (Groups): Cohort M: Any advanced solid tumor that has failed at least one line of therapy and is TMB-H (?10 mut/Mb, F1CDx assay), excluding dMMR/MSI-H tumors. Note: For subjects to be eligible for enrollment in Group M, they must have failed at least one line of standard of care systemic therapy (ie, not treatment naïve), with the exception of CRC subjects who must have failed at least 2 lines of standard of care systemic therapy Note: SUBJECTS WILL NOT BE ELIGIBLE TO ENROLL INTO GROUP M UNLESS TMB AND MSI STATUS CAN BE ASSESSED USING TISSUE FROM THE SAME SINGLE TUMOR SPECIMEN. SUBJECTS WITH PREVIOUSLY KNOWN dMMR AND/OR MSI-H STATUS SHOULD NOT BE SCREENED FOR COHORT M.

World
Responsible organization
:
Frauenklinik Frauenklinik Ismaninger Str. 22 81675 München Germany
Indications
Classification Code Description
ICD-10-GM U99.-! Nicht belegte Schlüsselnummer
Trial design
World
Phase
:
II
Status
World
Status
:
Recruitment active
Votes
World
Institutional review board - vote
:
Positive
World
Institutional review board - vote date
:
2016-01-14
Initiiation & lock
World
Date of lock (planned / actual)
:
Unknown / Unknown
Therapy
World
Therapy line
:
1
World
Therapy
:

Zielgerichtet - Therapieart: palliativ

Participants
Function Prename Surname Organization
World Responsible contact Holger Bronger Frauenklinik Frauenklinik Ismaninger Str. 22 81675 München Germany Magnifier