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NCT05061134 · ClinicalTrials.gov registry record · Phase 2
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
A Phase 2 study of Melanoma, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 2
- Development phase
- 194
- Enrollment target
- 20
- Study locations
NCT05061134: Active Phase 2 study of Melanoma, sponsored by AstraZeneca.
NCT05061134 is a Phase 2 study of Melanoma that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 194 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061134, a Phase 2 study of Melanoma, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 194 participants
- Enrollment target
- 20
- Study locations
Study Summary
Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhibition.
Primary Outcome
ORR was defined as the proportion of participants who had a complete response (CR) or partial response (PR) prior to any evidence of progression (as defined by Response Evaluation Criteria in Solid Tumours \[RECIST\] 1.1) that is confirmed at least 4 weeks later. As per planned in protocol, this outcome measure was assessed only for main study.
Conditions Studied
Interventions
- BIOLOGICAL Durvalumab
- DRUG Ceralasertib
Study Locations (20)
Other
- Research Site - Darlinghurst
- Research Site - East Melbourne
- Research Site - Herston
- Research Site - Woolloongabba
- Research Site - Belgium
- Research Site - Bruges
- Research Site - Ghent
- Research Site - Leuven
- Research Site - Bobigny
- Research Site - Boulogne-Billancourt
California
- Research Site - Los Angeles
- Research Site - Sacramento
- Research Site - San Francisco
Ontario
- Research Site - Toronto
- Research Site - Toronto
Florida
- Research Site - Tampa
Maryland
- Research Site - Lutherville-Timonium
Tennessee
- Research Site - Nashville
Alberta
- Research Site - Edmonton
Quebec
- Research Site - Ste-Foy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2022-08-11 |
| Est. Completion | 2026-11-02 |
| Phase | Phase 2 |
What the registry record for NCT05061134 still lists
NCT05061134 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Durvalumab is the first listed.
NCT05061134 names 20 study sites across 8 states, led by Other, California, Ontario.
Frequently Asked Questions
What is clinical trial NCT05061134 about?
NCT05061134 is a clinical study titled "A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition". Main study: This is an open-label, phase 2 study that aims to evaluate the efficacy and safety/tolerability of ceralasertib, when administered as monotherapy and in combination with durvalumab in participants with unresectable or advanced melanoma and primary or secondary resistance to PD-(L)1 inhib...
What is the current status of trial NCT05061134?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 194 participants. The study started on 2022-08-11. Estimated completion is 2026-11-02.
What conditions does trial NCT05061134 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT05061134?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Ceralasertib (DRUG).
Who is sponsoring clinical trial NCT05061134?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05061134 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Tennessee, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Melanoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05061134's enrollment target sits among peer trials
194 70th of 266 higher than 197 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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Neoadjuvant Immune Checkpoint Blockade + a Prebiotic Food-enriched Dietary Intervention to Optimize Immune Response in Melanoma: NEO-PreFED
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Zimberelimab (AB122) With TIGIT Inhibitor Domvanalimab (AB154) in PD-1 Relapsed/Refractory Melanoma
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A Study of IBI363 in Subjects with Advanced Solid Malignancies
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Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
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