Roche results post for two terminated Morpheus umbrella trials; new Phase 1/2 studies registered

Roche and its partners had a heavy week of registry updates spanning terminated trials with new results, an early efficacy readout in colorectal cancer, and several newly posted or recruiting Phase 1/2 studies.

• The MORPHEUS-UC trial, a Phase Ib/II umbrella study of immunotherapy combinations in urothelial carcinoma sponsored by Roche, was terminated because the sponsor decided not to continue development of certain treatment combinations.¹ The study had enrolled 272 participants¹ and results were first posted 2026-08-03.
• The Morpheus-Gastric and Esophageal Cancer study, a Phase Ib/II umbrella trial of immunotherapy combinations sponsored by Roche, was also terminated because the sponsor decided not to continue development of certain treatment combinations.² It had enrolled 219 participants² and results were first posted 2026-08-03.
• The completed OBERTO-301 trial, a Phase II study combining the PolyPEPI1018 vaccine with atezolizumab in MSS metastatic colorectal cancer patients who progressed on prior therapy, posted results. The study enrolled 18 participants³ who received the vaccine and atezolizumab on an every-3-week schedule, sponsored by Treos Bio with Mayo Clinic and Hoffmann-La Roche as collaborators.
• A Phase 1 dose-escalation study of subcutaneous RO7845860 in relapsing multiple sclerosis, sponsored by Roche and known by the acronym NOVA-BEAM, was registered and is not yet recruiting, with an estimated enrollment of 85 participants⁴ and an estimated start of 2026-11-23.
• A Phase II safety study of inavolisib plus fulvestrant, with or without palbociclib, in PIK3CA-mutated HR-positive, HER2-negative advanced breast cancer patients who also have type 2 diabetes was registered by Roche, not yet recruiting, with an estimated enrollment of 40 participants⁵.
• A Phase 1 study assessing how renal impairment affects the pharmacokinetics and safety of a single oral dose of RO7795081, sponsored by Roche, is recruiting at two U.S. sites, with an estimated enrollment of 60 participants⁶.