Study Evaluating Safety Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM)

  • STATUS
    Not Recruiting
  • End date
    Nov 1, 2023
  • participants needed
    40
  • sponsor
    GlaxoSmithKline
Updated on 26 May 2021
Investigator
US GSK Clinical Trials Call Center
Primary Contact
GSK Investigational Site (3.7 mi away) Contact
+17 other location
cancer
measurable disease
lenalidomide
bortezomib
line of therapy
carfilzomib
proteasome inhibitor
refractory multiple myeloma
ixazomib
pomalidomide
immunomodulatory imide drug

Summary

This is a phase I/II, single arm, open label, two-part study that will assess safety, tolerability and clinical activity of GSK2857916 given in combination with a programmed cell death-1 (PD-1) inhibitor pembrolizumab in subjects with RRMM. This study will enroll adult subjects with RRMM, who have undergone stem cell transplant or who are considered transplant ineligible. Part 1 is a dose escalation phase to evaluate the safety and tolerability of escalating doses of GSK2857916 in combination with 200 milligrams (mg) pembrolizumab to establish the recommended phase 2 dose (RP2D). The following dose levels of GSK2857916 are planned to be studied: 2.5 milligrams per kilograms (mg/kg) (dose level [DL] 1) and 3.4 mg/kg (DL2). Part 2 is a dose expansion cohort. Once the RP2D has been identified, an expansion cohort will open for enrolment to confirm the safety profile and to evaluate the clinical activity of the combination. Up to 40 evaluable subjects will be enrolled in this two-part study (up to 12 in Part 1, and 28 in Part 2).

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders
Treatment Pembrolizumab, GSK2857916
Clinical Study IdentifierNCT03848845
SponsorGlaxoSmithKline
Last Modified on26 May 2021

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