Human urinary bladder. Credit: Jpogi.

Bavarian Nordic has dosed the first patient in a Phase ll trial to investigate CV301 in combination with atezolizumab (TECENTRIQ) for the treatment of patients with locally advanced or metastatic urothelial bladder cancer.

CV301 is being developed by Bavarian as an active immunotherapy that targets two tumour-associated antigens, CEA and MUC1, while atezolizumab is developed by Roches as a checkpoint inhibitor.

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The Phase ll trial is a single-arm, multi-institutional study that aims to enrol 68 patients. It will employ a two-stage design within each cohort of the study.

Cohort one of the trial intends to examine the study drug combination as a first-line treatment for patients with urothelial bladder cancer who are not eligible for cisplatin-containing chemotherapy.

Cohort two aims to evaluate the drug combination as a second-line treatment for patients who have previously been treated with cisplatin-based chemotherapies.

“We are hopeful that the preclinical data demonstrating a synergistic effect of CV301 with checkpoint inhibition will translate into a new, much-needed treatment option for patients living with this disease.”

In the first stage, the trial plans to include around 40% of the subjects, with a target of nearly 25% of the subjects required to achieve an objective response before enrolling the remaining subjects in the second stage.

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The trial’s key secondary measures comprise progression-free survival (PFS), overall survival (OS) and duration of response.

Bavarian Nordic president and CEO Paul Chaplin said: “We are hopeful that the preclinical data demonstrating a synergistic effect of CV301 with checkpoint inhibition will translate into a new, much-needed treatment option for patients living with this disease.”

The company plans to complete the trial by November 2023, with the primary completion date anticipated in December 2021.