Melanoma Clinical Trial
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 inhibition.
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.
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.
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
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.
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There are 67 Locations for this study
Los Angeles California, 90024, United States
Sacramento California, 95816, United States
San Francisco California, 94143, United States
Tampa Florida, 33612, United States
Lutherville-Timonium Maryland, 21093, United States
Nashville Tennessee, 37232, United States
East Melbourne , 3002, Australia
Herston , 4029, Australia
Woolloongabba , 4102, Australia
Belgium , 1200, Belgium
Bruges , 8000, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Edmonton Alberta, t6G1Z, Canada
London Ontario, N6A 4, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Ste-Foy Quebec, G1V 4, Canada
Bobigny , 93009, France
Boulogne Billancourt , 92100, France
Marseille Cedex 5 , 13385, France
Paris , 75475, France
Pau Cedex , 64046, France
Pierre Benite Cedex , 69310, France
Poitiers , 86021, France
Vandoeuvre-Les-Nancy , 54511, France
Villejuif Cedex , 94805, France
Berlin , 10117, Germany
Buxtehude , 21614, Germany
Heidelberg , 69120, Germany
Heilbronn , 74078, Germany
Kiel , 24105, Germany
Mainz , 55131, Germany
München , 80337, Germany
Regensburg , 93053, Germany
Schwerin , 19049, Germany
Tuebingen , D-720, Germany
Aviano , 33081, Italy
Candiolo , 10060, Italy
Milano , 20141, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Perugia , 06156, Italy
Roma , 00168, Italy
Siena , 53100, Italy
Goyang , 410-7, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Brzozów , 36-20, Poland
Gdańsk , 80-21, Poland
Kraków , 31-11, Poland
Lodz , 93-51, Poland
Poznan , 60-35, Poland
Warszawa , 02-78, Poland
Barcelona , 08035, Spain
Barcelona , 08041, Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Málaga , 29009, Spain
Pozuelo de Alarcon , 28223, Spain
Cambridge , CB2 0, United Kingdom
Chelsea , SW3 6, United Kingdom
Manchester , M20 4, United Kingdom
Northwood , HA6 2, United Kingdom
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