NCT03848845: Phase 1/2: GSK2857916 in Combination With Pembrolizumab in RRMM Myeloma- DREAMM 4
Updated: Sep 19, 2022
NCT03848845: Phase 1/2: Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 4)
Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 4)
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).
Sponsor
Collaborator
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT03848845
Official Title: A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of GSK2857916 Administered in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma
(DREAMM 4)
First Posted : February 21, 2019
Click here for details on ClinicalTrials.gov
Drug: belantamab mafodotin
Drug: Pembrolizumab
Belantamab Mafodotin
BELANTAMAB MAFODOTIN
Belantamab Mafodotin-blmf
Blenrep
GSK2857916
J6M0-mcMMAF
Immunoglobulin G4, Anti-(Human Programmed Cell Death 1); Humanized Mouse Monoclonal (228-L-proline(H10-S>P))gamma 4 Heavy Chain (134-218')-disulfide with Humanized Mouse Monoclonal Kappa Light Chain Dimer (226-226'':229-229'')-bisdisulfide
Keytruda
Lambrolizumab
MK-3475
Pembrolizumab
PEMBROLIZUMAB
SCH 900475
Locations
United States, Georgia
United States, Indiana
United States, North Carolina
United States, Wisconsin
Canada, Alberta
Canada, Ontario
Europe
Germany
Spain
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