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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
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).