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A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
Sponsor: AstraZeneca
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
Ceralasertib
Ceralasertib (240 mg) will be administered orally twice daily.
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