Dr. Drakaki on the Design of the MORPHEUS-mUC Trial in Urothelial Carcinoma

Alexandra Drakaki, MD, oncologist/hematologist at the University of California, Los Angeles, discusses the design of the MORPHEUS-mUC trial in advanced/metastatic urothelial carcinoma.

With the use of immunotherapy, investigators are trying to enable preexisting immunity to create an effective response to cancer, says Drakaki. The phase Ib/II MORPHEUS-mUC trial will evaluate 6 immunotherapy combinations compared with a single immunotherapy control in patients with locally advanced/metastatic urothelial carcinoma who progressed during or after a platinum-containing regimen.

The PD-L1 inhibitor atezolizumab (Tecentriq) will be combined with agents that target different mechanisms via CD47, CD38, DPP-4, nectin-4, interleukin-6 receptor, and PARP, adds Drakaki.

Patients enrolled in the study will start in stage I of the trial, in which they will be randomized to either the control arm of atezolizumab monotherapy or 1 of the following experimental arms: atezolizumab plus either enfortumab vedotin-ejfv (Padcev), niraparib (Zejula), magrolimab (Hu5F9-G4), isatuximab-irfc (Sarclisa), linagliptin (Tradjenta), or tocilizumab (Actemra).

At the time of progression, if they have a good performance status, no safety concerns, and available tissue, they will undergo biopsy. Then, they will be moved into the stage II portion of the trial, says Drakaki. In stage II, patients will be randomized to receive either atezolizumab plus either enfortumab vedotin-ejfv or linagliptin, concludes Drakaki.