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ACTIVE NOT RECRUITING
NCT05061134
PHASE2

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 130 Years

Study Type

INTERVENTIONAL

Enrollment

194

Start Date

2022-08-11

Completion Date

2026-11-02

Last Updated

2025-07-31

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ceralasertib

Ceralasertib (240 mg) will be administered orally twice daily.

BIOLOGICAL

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.

Locations (66)

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Los Angeles, California, United States

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Sacramento, California, United States

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San Francisco, California, United States

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Tampa, Florida, United States

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Lutherville-Timonium, Maryland, United States

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Nashville, Tennessee, United States

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Darlinghurst, Australia

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East Melbourne, Australia

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Herston, Australia

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Woolloongabba, Australia

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Belgium, Belgium

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Bruges, Belgium

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Ghent, Belgium

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Leuven, Belgium

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Ste-Foy, Quebec, Canada

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Bobigny, France

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Boulogne-Billancourt, France

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Marseille, France

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Paris, France

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Pau, France

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Pierre-Bénite, France

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Poitiers, France

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Vandœuvre-lès-Nancy, France

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Villejuif, France

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Berlin, Germany

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Buxtehude, Germany

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Heidelberg, Germany

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Heilbronn, Germany

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Kiel, Germany

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Mainz, Germany

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München, Germany

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Regensburg, Germany

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Schwerin, Germany

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Tübingen, Germany

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Candiolo, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Perugia, Italy

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Roma, Italy

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Siena, Italy

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Brzozów, Poland

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Gdansk, Poland

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Krakow, Poland

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Lodz, Poland

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Poznan, Poland

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Warsaw, Poland

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Goyang, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Málaga, Spain

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Pamplona, Spain

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Pozuelo de Alarcón, Spain

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Cambridge, United Kingdom

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Chelsea, United Kingdom

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Manchester, United Kingdom

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Northwood, United Kingdom