Malignant mesothelioma treated with immune checkpoint inhibitors 
with or without cancer vaccine (the NIPU-study)

The NIPU trial was presented at the ESMO congress. While the primary end-point of progression-free survival (PFS) evaluated by blinded independent review (BICR), supportive analyses revealed significant difference in favor of patients treated with the UV1 vaccine for objective response rate by BICR (16% compared to 31% in UV1-treated patients, OR 2.4) and for overall survival (OS) the (median OS 5.4 m compared to 11.1 months for UV1-treated patients, HR 0.73).

After reaching 69 events, the primary endpoint of the study has been published. The primary endpoint was statistically significant difference in progression free survival between the two treatment arms evaluated by blinded independent radiological review. The primary endpoint was not met. However, there was a significant difference between the treatment arms evaluated by local radiologists. There was also some signals in the data that suggest there may be a difference in overall survival, but the data is not mature and more time is needed for a final conclusion.
Ultimovacs press release about the results

The trial has completed accrual and randomised 118 patients.

A total of 109 patients are included in the trial. Only 9 patients remain to be included before completion of 118 patients.

Rigshospitalet, Copenhagen, Denmark,  has been initiated as study site

Val d’Hebron, Barcelona, Spain, has been initiated as study site

Publication on the NIPU-trial in Journal of Translational Medicine

Karolinska Institutet, Stockholm, Sweden, has been initiated as study site

Aalborg University Hospital, Ålborg, Denmark, has been initiated as study site

University of Western Australia, Perth, is now initiated as a sight and will shortly start inclusion of patients

Oslo University Hospital started inclusion in May 2020. Other sites are expected to start inclusion in November 2020. 

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