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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)

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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