A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
194actual
Sites
66
Countries
Australia, Belgium, Canada +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-11 | actual | When the study began enrolling |
| Primary completion | 2024-04-12 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-11-02 | estimated | The whole study's end, after follow-up |
| First posted | 2021-09-29 | actual | When this record first appeared on the registry |
| Results posted | 2025-05-21 | actual | When the sponsor posted results to the registry |
| Record updated | 2025-07-31 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Melanoma
Interventions
- Drug: Ceralasertib
- Biological: Durvalumab
Primary outcomes
what the primary-completion date above is the date OFMain Study: Objective Response Rate (ORR)
measured Cycle 1 Day 1 (Each Cycle is 28 days) until objective disease progression or the last evaluable assessment in the absence of progression, or data cut-off (1 year 8 months)
Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Center Tumor Region
measured Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-area in the Invasive Margin Region
measured Baseline, Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Center Tumor Region
measured Baseline, On-treatment (Cycle 0 Day 7), and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
Biopsy Study: Change From Baseline in CD8+ T-cells Tumour Infiltration-density in the Invasive Margin Region
measured Baseline, and Off-treatment (Cycle 0 Day 15-28) (each cycle is 28 days)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-12-17 · 1.7 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-03-12 · 2.4 MB · SAP_001.pdf
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