MONETTE: A Randomised Open-Label Phase 2 Study of Ceralasertib Monotherapy and Ceralasertib plus Durvalumab in Patients with Unresectable or Advanced Melanoma and Primary or Secondary Resistance to PD-(L)1 Inhibition

Brief description of study

The purpose of the study is to evaluate the efficacy and safety/tolerability of ceralasertib, when administered alone and in combination with with durvalumab. We want to understand the mechanism of action for ceralasertib plus durvalumab and investigate ceralasertib as an immune modulator. The study drugs ceralasertib and durvalumab are investigational, which means that they have not been approved for melanoma by the U.S Food and Drug Administration (FDA), the health authority that gives approval for new medicines to be prescribed in the United States, but the FDA has given its permission to test these agents in the current trial.


Clinical Study Identifier: s21-00907
ClinicalTrials.gov Identifier: NCT05061134
Principal Investigator: Jeffrey S. Weber.


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