Melanoma Clinical Trial

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

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.

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Full Description

Biopsy sub-study: This is an open-label, non-randomised, sub-study planned in participants suitable for 3 mandatory biopsies. Serial tumour biopsies are mandated in participants recruited into the sub-study and will be taken at baseline during the screening period, during treatment with ceralasertib monotherapy and during the off-treatment period of ceralasertib monotherapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants must have a histologically or cytologically confirmed diagnosis of unresectable or metastatic melanoma of cutaneous, acral or mucosal subtype
Availability of an archival tumour sample and a fresh tumour biopsy taken at screening
Patient must have received at least 1 prior immunotherapy (anti-PD-(L)1 ± anti-CTLA-4 [Cytotoxic T-lymphocyte-associated protein 4]) for a minimum of 6 weeks and no more than 2 prior regimens in the metastatic setting. Patients must have confirmed progression during treatment with a PD-(L)1 inhibitor +/- a CTLA-4 inhibitor.
The interval between the last dose of anti-PD-(L)1, BRAF/MEK (B-Rapidly Accelerated Fibrosarcoma gene/mitogen-activated protein kinase gene) inhibitor and the first dose of the study regimen must be a minimum of 14 days
Measurable disease by RECIST 1.1.
Patients must have a life expectancy ≥3 months from proposed first dose date.
Biopsy Sub-study: Consent to the provision of 3 mandatory tumour biopsies.

Exclusion Criteria:

Patients must not have experienced a toxicity that led to permanent discontinuation of prior checkpoint inhibitors (CPI) treatment.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 3 years before the first dose of study treatment
Uveal melanoma
Must not have experienced a Grade ≥ 3 immune-related AE or an immune-related neurologic or ocular AE of any grade while receiving prior immunotherapy
History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Patients with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers may be permitted upon discussion with the study clinical lead.
History of organ transplant that requires use of immunosuppressive medications
Inadequate bone marrow and impaired hepatic or renal function
Known active infection requiring systemic therapy, active hepatitis infection, positive hepatitis C virus antibody, hepatitis B virus (HBV) surface antigen or HBV core antibody (anti-HBc), at screening
Patients with confirmed COVID-19 infection by polymearse chain reaction test who have not made a full recovery.

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

195

Study ID:

NCT05061134

Recruitment Status:

Recruiting

Sponsor:

AstraZeneca

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There are 75 Locations for this study

See Locations Near You

Research Site
Los Angeles California, 90024, United States
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Sacramento California, 95816, United States
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San Francisco California, 94143, United States
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Tampa Florida, 33612, United States
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Lutherville-Timonium Maryland, 21093, United States
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Rochester Minnesota, 55905, United States
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New York New York, 10065, United States
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Pittsburgh Pennsylvania, 15232, United States
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Nashville Tennessee, 37232, United States
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East Melbourne , 3002, Australia
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Herston , 4029, Australia
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Woolloongabba , 4102, Australia
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Belgium , 1200, Belgium
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Bruges , 8000, Belgium
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Edmonton Alberta, t6G1Z, Canada
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London Ontario, N6A 4, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Ste-Foy Quebec, G1V 4, Canada
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Bobigny , 93009, France
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Boulogne Billancourt , 92100, France
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Marseille Cedex 5 , 13385, France
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Paris , 75475, France
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Pau Cedex , 64046, France
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Pierre Benite Cedex , 69310, France
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Poitiers , 86021, France
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Rennes , 35042, France
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Vandoeuvre-Les-Nancy , 54511, France
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Villejuif Cedex , 94805, France
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Berlin , 10117, Germany
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Berlin , 12351, Germany
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Buxtehude , 21614, Germany
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Dresden , 01307, Germany
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Heidelberg , 69120, Germany
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Heilbronn , 74078, Germany
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Kiel , 24105, Germany
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Köln , 50924, Germany
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Mainz , 55131, Germany
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München , 80337, Germany
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Regensburg , 93053, Germany
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Schwerin , 19049, Germany
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Tuebingen , D-720, Germany
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Aviano , 33081, Italy
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Candiolo , 10060, Italy
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Milano , 20141, Italy
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Napoli , 80131, Italy
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Padova , 35128, Italy
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Perugia , 06156, Italy
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Roma , 00168, Italy
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Siena , 53100, Italy
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Goyang , 410-7, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Brzozów , 36-20, Poland
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Gdańsk , 80-21, Poland
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Kraków , 31-11, Poland
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Lodz , 93-51, Poland
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Poznan , 60-35, Poland
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Warszawa , 02-78, Poland
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Barcelona , 08035, Spain
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Barcelona , 08041, Spain
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Madrid , 28007, Spain
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Madrid , 28027, Spain
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Madrid , 28034, Spain
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Madrid , 28040, Spain
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Málaga , 29009, Spain
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Pozuelo de Alarcon , 28223, Spain
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Cambridge , CB2 0, United Kingdom
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Chelsea , SW3 6, United Kingdom
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Manchester , M20 4, United Kingdom
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Northwood , HA6 2, United Kingdom
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Southampton , SO166, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 2

Estimated Enrollment:

195

Study ID:

NCT05061134

Recruitment Status:

Recruiting

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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