Study identifier:D533AC00001
ClinicalTrials.gov identifier:NCT05061134
EudraCT identifier:2021-001722-21
CTIS identifier:N/A
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
Melanoma
Phase 2
No
Ceralasertib
All
194
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Main study: Ceralasertib + Durvalumab Participants will receive ceralasertib on Days 1 to 7 plus durvalumab Day 8, once in 28 days (Q28D), until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met. | Drug: Ceralasertib Ceralasertib (240 mg) will be administered orally twice daily. Biological/Vaccine: Durvalumab Durvalumab (1500 mg) will be administered intravenously once every 28 days for participants who weight above > 30 kgs. For participants who weigh below ≤ 30 kgs, weight-based dosing equivalent to 20 mg/kg of durvalumab will be administered. |
Experimental: Main study: Ceralasertib Participants will receive ceralasertib on Days 1 to 7, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met. | Drug: Ceralasertib Ceralasertib (240 mg) will be administered orally twice daily. |
Experimental: Biopsy Sub-study: Ceralasertib + Durvalumab From Cycle 1, participants will receive combination of ceralasertib twice daily (BD) Days 1 to 7 plus durvalumab Day 8, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or a study treatment discontinuation criterion is met. | Drug: Ceralasertib Ceralasertib (240 mg) will be administered orally twice daily. Biological/Vaccine: Durvalumab Durvalumab (1500 mg) will be administered intravenously once every 28 days for participants who weight above > 30 kgs. For participants who weigh below ≤ 30 kgs, weight-based dosing equivalent to 20 mg/kg of durvalumab will be administered. |
Experimental: Biopsy study: Ceralasertib During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28. | Drug: Ceralasertib Ceralasertib (240 mg) will be administered orally twice daily. |