GSK-linked trials: six new registrations this week, all not yet recruiting

This week brought six new trial registrations tied to GSK, all listed as not yet recruiting.

• A Phase 3b study, "DuraSTAR" (NCT07740720), will test different durations of neoadjuvant dostarlimab monotherapy in patients with untreated Stage II/III dMMR/MSI-H locally advanced rectal cancer. The main goal is to find out whether a longer treatment period with dostarlimab can help more participants have a complete response to treatment and avoid standard treatments like chemotherapy, radiation treatment, or surgery.¹ Estimated enrollment is 90 participants (estimated)¹.
• A Phase 3a study (NCT07742644) will compare an investigational combined measles, mumps, rubella and varicella vaccine (MMRVNS) against the licensed ProQuad vaccine as a second dose in children aged 4 to 6. The purpose is to evaluate how consistently 3 different manufacturing lots of the GSK's investigational measles, mumps, rubella, and varicella (MMRVNS) vaccine will produce an immune response.² Estimated enrollment is 1860 participants (estimated)².
• A Phase 1b crossover study, "DynaMMic-2" (NCT07742527), will compare a subcutaneous formulation of belantamab against the intravenous form in multiple myeloma patients on standard-of-care maintenance therapy. This study aims to compare how belantamab behaves in the body when given as an injection under the skin (SC) versus into a vein (IV) in participants with multiple myeloma who are receiving standard of care treatment, to enable eventual development of SC formulation.³ Estimated enrollment is 22 participants (estimated)³.
• Two related Phase 1b registrations cover aletekitug (GSK1070806, anti-IL-18) in adults with moderate to severe ulcerative colitis: a master platform protocol (NCT07747467) and its first sub-study (NCT07747480). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.⁴ Each registration lists an estimated enrollment of 16 participants (estimated)^4,5.
• A Phase 2 study, "REBEL" (NCT07748689), is sponsored by the Polish Myeloma Consortium, with the Medical Research Agency of Poland and GSK listed as collaborators. This study is testing whether a lower dose of belantamab mafodotin used together with pomalidomide and dexamethasone can provide similar effectiveness with fewer side effects compared with the standard dose in patients with relapsed or refractory multiple myeloma.⁶ Estimated enrollment is 228 participants (estimated)⁶.