Back to resultsA Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition (MONETTE)
Primary Purpose
Melanoma
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ceralasertib
Durvalumab
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma focused on measuring Unresectable or Advanced Melanoma, Efficacy, Safety
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Main study: Ceralasertib + Durvalumab
Main study: Ceralasertib
Biopsy Sub-study: Ceralasertib + Durvalumab
Biopsy study: Ceralasertib
Arm Description
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.
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.
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.
During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28.
Outcomes
Primary Outcome Measures
Main study: Objective response rate (ORR)
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.
Biopsy sub-study: CD8+ T-cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies
Changes in CD8+ T cell infiltration of tumours induced by ceralasertib monotherapy will be evaluated.
1 cycle length is 28 days.
Secondary Outcome Measures
Main study and Biopsy sub-study: Duration of Response (DoR)
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.
Main study and Biopsy sub-study: Time to objective response (TTR)
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.
Main study and Biopsy sub-study: Percentage change in target lesion tumour size
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.
Biopsy sub-study: ORR
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.
Main study and Biopsy sub-study: Progression free survival (PFS)
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.
Main study and Biopsy sub-study: Overall survival (OS)
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
Biopsy sub-study: Pre-treatment presence and/or on-treatment and/or off-treatment changes in PD-L1 and pRAD50
Tumour tissue samples for the analysis of tumoural biomarkers that change following treatment with ceralasertib will collected.
1 cycle length is 28 days.
Main study and Biopsy sub-study: Number of adverse events and serious adverse events
Adverse events will recorded to evalute the safety and tolerability of the study drugs.
Main study: Concentration of ceralasertib in plasma
To assess the Pharmakokinetic (plasma peak and trough concentrations) of ceralasertib alone and when in combination with durvalumab.
Biopsy sub-study: Assessment of proliferation of carcinoma in Ki67 marker (Marker Of Proliferation Ki-67) or CD8+ T cells immune cells
To assess changes in the proliferation of carcinoma and/or immune cells within tumours induced by ceralasertib monotherapy.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05061134
Brief Title
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
Acronym
MONETTE
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 11, 2022 (Actual)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
April 12, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Unresectable or Advanced Melanoma, Efficacy, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Main study: Ceralasertib + Durvalumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Main study: Ceralasertib
Arm Type
Experimental
Arm Description
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.
Arm Title
Biopsy Sub-study: Ceralasertib + Durvalumab
Arm Type
Experimental
Arm Description
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.
Arm Title
Biopsy study: Ceralasertib
Arm Type
Experimental
Arm Description
During Cycle 0, participants will receive ceralasertib on Days 1 to 7, followed by an off-treatment period between Days 8 to 28.
Intervention Type
Drug
Intervention Name(s)
Ceralasertib
Intervention Description
Ceralasertib (240 mg) will be administered orally twice daily.
Intervention Type
Biological
Intervention Name(s)
Durvalumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Main study: Objective response rate (ORR)
Description
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.
Time Frame
8 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
Title
Biopsy sub-study: CD8+ T-cells tumour infiltration assessed in baseline, on-treatment and off-treatment tumour biopsies
Description
Changes in CD8+ T cell infiltration of tumours induced by ceralasertib monotherapy will be evaluated.
1 cycle length is 28 days.
Time Frame
Screening, on-treatment and off-treatment during Cycle 1
Secondary Outcome Measure Information:
Title
Main study and Biopsy sub-study: Duration of Response (DoR)
Description
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.
Time Frame
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)
Title
Main study and Biopsy sub-study: Time to objective response (TTR)
Description
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.
Time Frame
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)
Title
Main study and Biopsy sub-study: Percentage change in target lesion tumour size
Description
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.
Time Frame
Main study: 16 weeks; Biopsy study: 20 weeks
Title
Biopsy sub-study: ORR
Description
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.
Time Frame
Biopsy study: 12 weeks after the start of treatment (Cycle 1 Day 1) until objective disease progression (approx 2 years)
Title
Main study and Biopsy sub-study: Progression free survival (PFS)
Description
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.
Time Frame
From screening until objective disease progression or death (approx. up to 1 year)
Title
Main study and Biopsy sub-study: Overall survival (OS)
Description
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
Time Frame
From screening until death (approx. up to 2 years)
Title
Biopsy sub-study: Pre-treatment presence and/or on-treatment and/or off-treatment changes in PD-L1 and pRAD50
Description
Tumour tissue samples for the analysis of tumoural biomarkers that change following treatment with ceralasertib will collected.
1 cycle length is 28 days.
Time Frame
Biopsy study: Screening, on-treatment and off-treatment during Cycle 1
Title
Main study and Biopsy sub-study: Number of adverse events and serious adverse events
Description
Adverse events will recorded to evalute the safety and tolerability of the study drugs.
Time Frame
From screening until treatment discontinuation plus 90 day safety follow up (approx. up to 1 year)
Title
Main study: Concentration of ceralasertib in plasma
Description
To assess the Pharmakokinetic (plasma peak and trough concentrations) of ceralasertib alone and when in combination with durvalumab.
Time Frame
Cycle 1, 2, 3 Day 7 (each cycle is 28 days)
Title
Biopsy sub-study: Assessment of proliferation of carcinoma in Ki67 marker (Marker Of Proliferation Ki-67) or CD8+ T cells immune cells
Description
To assess changes in the proliferation of carcinoma and/or immune cells within tumours induced by ceralasertib monotherapy.
Time Frame
From baseline, on-treatment and off-treatment until 24 months after the last patient (approx 2 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Research Site
City
Lutherville-Timonium
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Research Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Research Site
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
Facility Name
Research Site
City
Herston
ZIP/Postal Code
4029
Country
Australia
Facility Name
Research Site
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
Facility Name
Research Site
City
Belgium
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Research Site
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
t6G1Z2
Country
Canada
Facility Name
Research Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Research Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Research Site
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Research Site
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Research Site
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Research Site
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Research Site
City
Pau Cedex
ZIP/Postal Code
64046
Country
France
Facility Name
Research Site
City
Pierre Benite Cedex
ZIP/Postal Code
69310
Country
France
Facility Name
Research Site
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Research Site
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Research Site
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Research Site
City
Heilbronn
ZIP/Postal Code
74078
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Research Site
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Research Site
City
Schwerin
ZIP/Postal Code
19049
Country
Germany
Facility Name
Research Site
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Research Site
City
Aviano
ZIP/Postal Code
33081
Country
Italy
Facility Name
Research Site
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Perugia
ZIP/Postal Code
06156
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Research Site
City
Goyang
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Research Site
City
Brzozów
ZIP/Postal Code
36-200
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Research Site
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Research Site
City
Chelsea
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
A Study of Ceralasertib Monotherapy and Ceralasertib Plus Durvalumab in Patients With Melanoma and Resistance to PD-(L)1 Inhibition
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