trialsTrialActive

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition

A phase 2 trial of Ceralasertib, Durvalumab in melanoma, run by AstraZeneca, active and no longer recruiting.

Also called: MONETTE

A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition is a phase 2 interventional study registered as NCT05061134 by AstraZeneca, with 194 participants enrolled, started 2022-08-11 and due to reach its primary completion in 2024-04-12. Interventions recorded: Ceralasertib, Durvalumab. Conditions listed: Melanoma. Results were posted on ClinicalTrials.gov in 2025; the figures recorded here are the registry's, not a publication's.

Setting

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

Phase

Phase 2

Sponsor

AstraZeneca

Registry

Started

2022-08-11

Reported

2025

Enrolled

194 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

194 enrolled

Main Study: Objective Response Rate (ORR)primaryresponse endpoint

9.3 vs 5.8 out of 100 had their tumour shrink with Main Study: Ceralasertib + Durvalumab compared with Main Study: Ceralasertib Monotherapy; 3.5 more per 100.
Roughly one extra person helped for every 29 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Main Study and Biopsy Study: Overall Survival (OS)survival endpoint

Median 16 vs 12.3 months with Main Study: Ceralasertib + Durvalumab compared with Main Study: Ceralasertib Monotherapy; about 3.7 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Biopsy Study: Ceralasertib + Durvalumab Here, NA indicate that median and upper limit of 95% CI was not evaluable due to insufficient number of participants with events and due to the duration of fol….

Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.

Main Study and Biopsy Study: Progression Free Survival (PFS)surrogate endpoint

Median 2 vs 1.9 months with Main Study: Ceralasertib + Durvalumab compared with Main Study: Ceralasertib Monotherapy; about 0.1 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: Biopsy Study: Ceralasertib + Durvalumab 2.8 months.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Caveats

These results apply to the people the trial enrolled: 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. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

194 enrolled.

Main Study: Objective Response Rate (ORR)primary

Main Study: Ceralasertib + Durvalumab9.3 of 100

n = 97

Main Study: Ceralasertib Monotherapy5.8 of 100

n = 52

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95% CI 4.3 to 16.9; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication · 95% CI 1.2 to 15.9

Main Study and Biopsy Study: Overall Survival (OS)

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95% CI 10.48 to NA; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication · 95% CI 9.46 to NA · Here, NA indicate that median and upper limit of 95% CI was not evaluable due to insufficient number of participants with events and due to the duration of fol…

Main Study and Biopsy Study: Progression Free Survival (PFS)

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95% CI 1.91 to 3.52; Figures from the ClinicalTrials.gov results section (first posted 2025-05-21), not from a publication · 95% CI 1.91 to 3.06 · 95% CI 2.76 to 4.47

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Main Study: Objective Response Rate (ORR)primary	Main Study: Ceralasertib + Durvalumab	97	9.3%	-	-	link
Main Study: Objective Response Rate (ORR)primary	Main Study: Ceralasertib Monotherapy	52	5.8%	-	-	link
Main Study and Biopsy Study: Overall Survival (OS)	Main Study: Ceralasertib + Durvalumab	100	16 months	-	-	link
	Main Study: Ceralasertib Monotherapy	51	12.32 months
	Biopsy Study: Ceralasertib + Durvalumab	41	Here, NA indicate that median and upper limit of 95% CI was not evaluable due to insufficient number of participants with events and due to the duration of fol…
Main Study and Biopsy Study: Progression Free Survival (PFS)	Main Study: Ceralasertib + Durvalumab	100	2 months	-	-	link
	Main Study: Ceralasertib Monotherapy	51	1.94 months
	Biopsy Study: Ceralasertib + Durvalumab	41	2.83 months

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