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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05061134
Registration number
NCT05061134
Ethics application status
Date submitted
22/09/2021
Date registered
29/09/2021
Titles & IDs
Public title
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
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Scientific 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
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Secondary ID [1]
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2021-001722-21
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Secondary ID [2]
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D533AC00001
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Universal Trial Number (UTN)
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Trial acronym
MONETTE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ceralasertib
Treatment: Other - Durvalumab
Experimental: Main study: Ceralasertib + Durvalumab - Participants will receive ceralasertib on Days 1 to 7 plus durvalumab Day 8, once in 28 days (Q28D), until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met.
Experimental: Main study: Ceralasertib - Participants will receive ceralasertib on Days 1 to 7, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or if a study treatment discontinuation criterion is met.
Experimental: Biopsy Sub-study: Ceralasertib + Durvalumab - From Cycle 1, participants will receive combination of ceralasertib twice daily (BD) Days 1 to 7 plus durvalumab Day 8, Q28D, until progressive disease, unacceptable toxicity, withdrawal of consent, or a study treatment discontinuation criterion is met.
Experimental: Biopsy study: Ceralasertib - During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28.
Treatment: Drugs: Ceralasertib
Ceralasertib (240 mg) will be administered orally twice daily.
Treatment: Other: 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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Main study: Objective response rate (ORR)
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Assessment method [1]
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ORR is the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as determined by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
1 cycle length is 28 days.
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Timepoint [1]
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8 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
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Primary outcome [2]
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Biopsy sub-study: CD8+ T-cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies
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Assessment method [2]
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Changes in CD8+ T cell infiltration of tumours induced by ceralasertib monotherapy will be evaluated.
1 cycle length is 28 days.
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Timepoint [2]
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Screening, on-treatment and off-treatment during Cycle 1
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Secondary outcome [1]
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Main study and Biopsy sub-study: Duration of Response (DoR)
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Assessment method [1]
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DoR will be defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 as assessed by BICR or death due to any cause.
1 cycle length is 28 days.
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Timepoint [1]
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Main study: 8 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years); Biopsy study: 12 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
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Secondary outcome [2]
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Main study and Biopsy sub-study: Time to objective response (TTR)
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Assessment method [2]
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Time to response is defined as the time from randomisation (or date of first dose of study treatment, for the biopsy sub-study) until the date of first documented objective response, which is subsequently confirmed per RECIST 1.1 as assessed by BICR.
1 cycle length is 28 days.
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Timepoint [2]
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Main study: 8 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years); Biopsy study: 12 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
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Secondary outcome [3]
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Main study and Biopsy sub-study: Percentage change in target lesion tumour size
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Assessment method [3]
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Percentage change from baseline in tumor lesions tumour size, where tumor size is the sum of the longest diameters of the target lesions.
1 cycle length is 28 days.
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Timepoint [3]
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Main study: 16 weeks; Biopsy study: 20 weeks
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Secondary outcome [4]
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Biopsy sub-study: ORR
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Assessment method [4]
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ORR is defined as the proportion of participants who have a confirmed CR or PR, as determined by BICR per RECIST 1.1.
1 cycle length is 28 days.
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Timepoint [4]
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Biopsy study: 12 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
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Secondary outcome [5]
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Main study and Biopsy sub-study: Progression free survival (PFS)
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Assessment method [5]
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PFS is defined as time from randomisation (or date of first dose for the biopsy sub-study) until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
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Timepoint [5]
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From screening until objective disease progression or death (approx. up to 1 year)
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Secondary outcome [6]
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Main study and Biopsy sub-study: Overall survival (OS)
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Assessment method [6]
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OS is defined as time from randomisation (or date of first dose for the biopsy sub-study) until the date of death due to any cause
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Timepoint [6]
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From screening until death (approx. up to 2 years)
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Secondary outcome [7]
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Biopsy sub-study: Pre-treatment presence and/or on-treatment and/or off-treatment changes in PD-L1 and pRAD50
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Assessment method [7]
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Tumour tissue samples for the analysis of tumoural biomarkers that change following treatment with ceralasertib will collected.
1 cycle length is 28 days.
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Timepoint [7]
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Biopsy study: Screening, on-treatment and off-treatment during Cycle 1
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Secondary outcome [8]
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Main study and Biopsy sub-study: Number of adverse events and serious adverse events
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Assessment method [8]
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Adverse events will recorded to evalute the safety and tolerability of the study drugs.
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Timepoint [8]
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From screening until treatment discontinuation plus 90 day safety follow up (approx. up to 1 year)
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Secondary outcome [9]
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Main study: Concentration of ceralasertib in plasma
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Assessment method [9]
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To assess the Pharmakokinetic (plasma peak and trough concentrations) of ceralasertib alone and when in combination with durvalumab.
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Timepoint [9]
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Cycle 1, 2, 3 Day 7 (each cycle is 28 days)
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Secondary outcome [10]
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Biopsy sub-study: Assessment of proliferation of carcinoma in Ki67 marker (Marker Of Proliferation Ki-67) or CD8+ T cells immune cells
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Assessment method [10]
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To assess changes in the proliferation of carcinoma and/or immune cells within tumours induced by ceralasertib monotherapy.
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Timepoint [10]
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From baseline, on-treatment and off-treatment until 24 months after the last patient (approx 2 years)
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/08/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
194
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - East Melbourne
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Recruitment hospital [2]
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Research Site - Herston
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Recruitment hospital [3]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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3002 - East Melbourne
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Recruitment postcode(s) [2]
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4029 - Herston
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Florida
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United States of America
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Maryland
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United States of America
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Tennessee
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Belgium
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Belgium
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Belgium
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Bruges
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Belgium
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Gent
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Belgium
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Leuven
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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France
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Bobigny
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France
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Boulogne Billancourt
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France
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Marseille Cedex 5
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France
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Paris
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France
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Pau Cedex
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France
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Pierre Benite Cedex
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France
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Poitiers
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France
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Vandoeuvre-Les-Nancy
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Berlin
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Mainz
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München
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Roma
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Siena
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Korea, Republic of
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Goyang
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Lodz
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Warszawa
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Barcelona
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Madrid
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Pamplona
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Cambridge
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Chelsea
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Manchester
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United Kingdom
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Northwood
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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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Trial website
https://clinicaltrials.gov/study/NCT05061134
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05061134