MONETTE: This phase II study is evaluating how safe, tolerable and effective targeted therapy (ceralasertib) is alone, and in combination with immunotherapy (durvalumab), in people with inoperable or advanced melanoma and primary or secondary resistance to PD(L)1 InhibitionA 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

Summary

This study has two parts: a Main Study and a Biospy Sub-Study. The Main Study has has two Experimental Arms that participants will be randomly allocated to. In Experimental Arm A, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7 plus durvalumab (1500mg, intravenously once every 28 days for those weighing more than 30kgs or at a weight-based dosing for those 30kgs or lighter) once in 28 days (Q28D). In Experimental Arm B, participants will receive ceralasertib (240mg, orally, twice daily) on Days 1 to 7, Q28D. The Biopsy Sub-Study is enrolling participants suitable for 3 mandatory biopsies. Serial tumour biopsies are mandated in participants recruited into the sub-study and will be taken at baseline during the screening period, during treatment with ceralasertib monotherapy and during the off-treatment period of ceralasertib monotherapy. The Biopsy Sub-Study has two experimental arms, that involve the same treatment as the Main Study (described above).