Study to Assess MEDI4736 With Either AZD9150 or AZD5069 in Advanced Solid Tumors & Relapsed Metastatic Squamous Cell Carcinoma of Head & Neck

A Phase 1b/2, Open-Label, Multicentre Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of MEDI4736 in Combination With AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Subsequently Comparing AZD9150 and AZD5069 Both as Monotherapy and in Combination With MEDI4736 as Second Line Treatment in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

This multicentre, open-label, Phase 1b/2 study is designed as a 2 part study consisting of a dose-escalation, safety run-in Part A and a dose-expansion Part B

Study Overview

• Status: Completed
• Conditions: Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck
• Intervention / Treatment: Drug: MEDI4736; Drug: AZD9150; Drug: AZD5069; Drug: tremelimumab (treme)

Detailed Description

The dose-escalation Part A of this study will involve patients with advanced solid malignancies refractory to standard therapy or for which no standard of care regimen currently exists. Approximately 30 evaluable patients per treatment arm (A1 or A2) will be enrolled. A3 will test viability of alternate dosing schedule for AZD5069, A4/A5 will evaluate AZD9150/AZD5069 in fixed dose combination with MEDI4736 and tremelimumab in solid tumors. there may also be safety run in cohorts enrolled (A6/A7) in specific solid tumor types (breast and prostate cancer).

Once the maximum tolerated doses (MTDs) for each of the 2 agents (AZD9150/AZD5069)in combination with MEDI4736 have been identified or the maximum doses of each of the 2 agents in combination with MEDI4736 have been reached, the dose expansion Part B of the study would commence. It will be conducted in patients with recurrent and/or metastatic (RM) squamous cell carcinoma of the head and neck (SCCHN). Between 68 and 266 eligible patients will be enrolled and will randomly assigned to 1 of the following 6 treatment arms or non randomized arm B7:

• Treatment arm B1: AZD9150 in combination with MEDI4736 in patients with prior exposure to anti-PD-(L)1 antibodies
• Treatment arm B2: AZD5069 in combination with MEDI4736 in patients with prior exposure to anti-PD-(L)1 antibodies
• Treatment arm B3: AZD9150 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (2L RM SCCHN)
• Treatment arm B4: AZD5069 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies
• Treatment arm B5: AZD9150 alone in patients with no prior exposure to anti-PD-(L)1 antibodies
• Treatment arm B6: AZD5069 alone in patients with no prior exposure to anti-PD-(L)1 antibodies
• Treatment arm B7: (non randomized): AZD9150 in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (1L RM SCCHN)
• Treatment arm B8: (non randomized): AZD9150 (every two weeks) in combination with MEDI4736 in patients with no prior exposure to anti-PD-(L)1 antibodies (1L RM SCCHN)

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Research Site
  • Brussels, Belgium, 1000
    • Research Site
  • Brussels, Belgium, 1200
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • Namur, Belgium, 5000
    • Research Site
• Germany
  • Berlin, Germany, 12200
    • Research Site
  • Cologne, Germany, 50670
    • Research Site
  • Dresden, Germany, 1307
    • Research Site
  • Frankfurt, Germany, 60488
    • Research Site
  • Hamburg, Germany, 20246
    • Research Site
  • Hanover, Germany, 30625
    • Research Site
  • Jena, Germany, 07743
    • Research Site
  • München, Germany, 81675
    • Research Site
• Italy
  • Milan, Italy, 20133
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Research Site
  • Hospitalet deLlobregat, Spain, 08907
    • Research Site
  • Madrid, Spain, 28041
    • Research Site
  • Madrid, Spain, 28040
    • Research Site
  • Toledo, Spain, 45004
    • Research Site
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Research Site
  • London, United Kingdom, SE1 9RT
    • Research Site
  • London, United Kingdom, SW3 6JB
    • Research Site
  • Manchester, United Kingdom, M20 4BX
    • Research Site
  • Surrey, United Kingdom, SM2 5PT
    • Research Site
  • Taunton, United Kingdom, TA1 5DA
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Research Site
  • California
    • Duarte, California, United States, 91010
      • Research Site
    • La Jolla, California, United States, 92093
      • Research Site
    • Los Angeles, California, United States, 90024
      • Research Site
    • Los Angeles, California, United States, 90089
      • Research Site
    • Orange, California, United States, 92868-3298
      • Research Site
    • San Francisco, California, United States, 94158
      • Research Site
  • Colorado
    • Denver, Colorado, United States, 80218
      • Research Site
  • Florida
    • Plantation, Florida, United States, 33324
      • Research Site
    • Sarasota, Florida, United States, 34232
      • Research Site
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Research Site
  • Montana
    • Billings, Montana, United States, 59101
      • Research Site
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States, 45267-2827
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Research Site
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Research Site
  • Washington
    • Seattle, Washington, United States, 98109
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Male and female patients must be at least 18 years of age.
• Has an Eastern Cooperative Oncology Group (ECOG) PS score of 0 or 1.
• Has measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) with a minimum size of 10 mm by computerised tomography (CT) scan, except lymph nodes which must have minimum short axis size of 15 mm (CT scan slice thickness no greater than 5 mm in both cases). Indicator lesions must not have been previously treated with surgery, radiation therapy, or radiofrequency ablation unless there is documented progression after therapy.
• Has undergone ≤3 previous regimens (depending on treatment arm) of cytoreductive therapies including, but not limited to, platinum-based compounds, taxanes, or 5-fluorouracil. for B7 & B8, no prior systemic treatments should have been received for RM SCCHN
• Adequate organ and marrow function
• Female subjects of childbearing potential and male subjects with partners of childbearing potential should ensure use of a highly effective method of birth control as defined in study protocol
• Additional inclusion for part A: Has a histological confirmation of a solid malignancy (other than HCC) that is refractory to standard therapy or for which no standard of care regimen currently exists.
• Addition inclusion for Part A (A6) Has a histological confirmation of castrate-resistant prostate cancer
• Additional inclusion for Part B:Has histologically and/or cytologically confirmed SCCHN that is RM and not amendable to curative therapy by surgery or radiation. Squamous cell carcinoma of the head and neck originating from the following sites is eligible: oral cavity, oropharynx, larynx, or hypopharynx. Has at least 1 SCCHN tumour lesion (TL) amenable to biopsy and must have failed, refused, or has been found to be ineligible for least 1 prior platinum-based chemotherapy for RM-SCCHN Additional inclusion criteria for Arms B1 & B2: must have had prior exposure to anti PDL-1 antibody
• Arms B1-B6: Has undergone 1-3 previous regimens of cytoreductive chemo-therapies Arm B7 & B8: with no prior exposure to anti-PD-(L)1 therapies and have received no prior systemic treatment for RM SCCHN

Key Exclusion Criteria:

- Spinal cord compression unless asymptomatic and not requiring steroids for at least 4 weeks before the start of study treatment. - Presently has a second malignancy other than SCCHN, or history of treatment for invasive cancer other than SCCHN in the past 3 years. Exceptions are: Previously treated in-situ carcinoma (ie, noninvasive) Cervical carcinoma stage 1B or less Noninvasive basal cell and squamous cell skin carcinoma Radically treated prostate cancer (prostatectomy or radiotherapy) with normal prostate-specific antigen, and not requiring ongoing antiandrogen hormonal therapy

• Patients must have completed any previous cancer-related treatments before enrolment. Any concurrent chemotherapy [Chemotherapy washout within 21 days or 5 half-lives (whichever is shorter) from enrolment], radiotherapy, immunotherapy, or biologic, or hormonal therapy for cancer excludes the patient (concurrent use of hormones for noncancer-related conditions [eg, insulin for diabetes and hormone replacement therapy] is acceptable),
• Experiencing CTCAE grade >1 events, experienced immune-related grade ≥3AEs with prior immunotherapy
• Has active or prior autoimmune disease within the past 2 years
• Has active or prior inflammatory bowel disease or primary immunodeficiency
• Undergone an organ transplant that requires use of immunosuppressive treatment
• Abnormalities in rhythm, conduction or morphology of resting 12-lead ECG
• uncontrolled comorbid conditions
• Received a live attenuated vaccine within 30 days of first study dose, unable to take oral medications
• History of allergic reactions to study compounds or excepients Additional exclusion criteria Part A: Patients with clinically active brain metastases and prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

Additional exclusion criteria Part B: Patients with brain metastases (known or suspected) Additional exclusion criteria Part B: treatment arms B3, B4, B5, B6, B7 and B8: prior exposure to AZD9150, AZD5069, MEDI4736, or any other anti PD (L)1 antibody.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

15

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A1: AZD9150 / MEDI4736; Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150
Experimental: Part A2: AZD5069 / MEDI4736; Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B1:AZD9150+MEDI4736:PDL1 pretreated; Patients in arm B1 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150
Experimental: Part B2:AZD5069+MEDI4736:PDL1 pretreated; Patients in arm B2 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B3: AZD9150+MED4736:naiive 2L; Patients in arm B3 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150
Experimental: Part B4:AZD5069+MEDI4736:naiive patients; Patients in arm B4 will be evaluated for efficacy until disease progression and then followed-up for safety and survival.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B5: AZD9150 in naiive patients; Patients in arm B5 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Drug: AZD9150; AZD9150
Experimental: Part B6:AZD5069 in naiive patients; Patients in arm B6 will be evaluated for efficacy until disease progression and then allowed to receive additional MEDI4736 and followed for safety and survival	Drug: AZD5069; AZD5069
Experimental: Part A3: AZD5069/MEDI4736; Patients allocated in cohort of arm A3 (AZD5069/MEDI4736) will be evaluated for DLT and viability as alternate dosing option for Phase 2 studies	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part A4: AZD9150/Treme/MEDI4736; Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150; Drug: tremelimumab (treme); tremelimumab
Experimental: Part A5: AZD5069/Treme/MEDI4736; Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069; Drug: tremelimumab (treme); tremelimumab
Experimental: Part A6: AZD9150/MEDI4736; Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150
Experimental: Part A7: AZD5069/MEDI4736; Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.	Drug: MEDI4736; MEDI4736; Drug: AZD5069; AZD5069
Experimental: Part B7: AZD9150+MEDI4736: naiive 1L; Patients in Arm B7 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150
Experimental: Part B8: AZD9150 (every other week)+MEDI4736: naive 1L; Patients in Arm B8 will be evaluated for efficacy until disease progression and then followed up for safety and survival	Drug: MEDI4736; MEDI4736; Drug: AZD9150; AZD9150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion	After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.	35 days
Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion	After completion of DLT period (35 days) for the maximum dose cohort. A CRM-based approach was used to identify the set of dose combinations where the incidence of DLT was ≤ 33%. The dose with expected DLT incidence closest and below 0.33 at this point was the "model estimated" MTD. During trial execution, the Safety Review Committee (SRC) determined the MTD.	35 days
Part A: Safety and Tolerability in Terms of Adverse Events	Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters	At every treatment and follow up visit until disease progression, an average of 1 year.
Part B: ORR (Objective Response Rate) in Patients With IL/2L RM-SCCHN.	proportion of patients who have an objective response at a given visit. ORR will be summarised by treatment group. Objective rate is defined as a CR or PR according to RECIST 1.1.	Assessed at every even-numbered cycles with RECIST until disease progression, up to 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and B: AZD9150 AUC0-6h at Lead in Day-7	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.	Lead in day -7, AUC from time 0 to 6h (post dose).
Part A and B: AZD9150 Cmax at Lead in Day -7	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.	Lead in day -7
Part A and B: AZD9150 AUC0-6h at Cycle 2 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.	Cycle 2 day 1, AUC from time 0 to 6 h post dose
Part A and B: AZD9150 Cmax at Cycle 2 Day 1		Cycle 2 day 1
Part A and B: AZD5069 AUC0-12h at Lead in Day -7	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.	Lead in day -7, AUC from time 0 to 12h post dose
Part A and B: AZD5069 Cmax at Lead in Day -7	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.	Lead in day -7
Part A and B: AZD5069 Cssmax at Cycle 2 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at around Tmax, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.	Cycle 2 day 1
Part A and B: AZD5069 AUCss at Cycle 2 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to calculate AUC, we need to have enough PK samples collected to enable AUC estimation. That is why we have a difference in actual AUC calculated number of subjects vs number of subjects participated.	Cycle 2 day 1
Part A and B: Durvalumab Cmax After Single Dose at Cycle 1 Day 1		Cycle 1 day 1
Part A and B: Durvalumab Ctrough After Multiple Doses at Cycle 4 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.	Cycle 4 day 1
Part A and B: Durvalumab Cmax After Multiple Doses at Cycle 8 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.	Cycle 8 day 1
Part A and B: Treme Cmax After Single Dose	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Cmax we need to have samples at end of infusion, which was not available for all the subjects in PK analysis set. That is why there is a difference between Cmax calculated number of subjects vs number of subjects participated.	Cycle 1 day 1
Part A and B: Treme Ctrough After Multiple Doses at Cycle 4 Day 1	If a subjects had at least one post dose PK sample they were part of PK analysis set. However, to estimate Ctrough we need to have samples at predose, which was not available for all the subjects in PK analysis set. That is why there is a difference between Ctrough calculated number of subjects vs number of subjects participated.	Cycle 4 day 1
Part A and B: Immunogenecity as Percent of ADA Positive Subjects	Subject was considered ADA positive if any post dose samples had ADA positive result. Result was not stratified based on post dose time points.	Throughout the study, up to 3.3 years
Part A: Antitumour Activity in Monotherapy and Combination Arms of Study	complete response, partial response, stable disease or progressive disease based on RECIST	assessed at every even numbered cycle with RECIST until disease progression, an average of 1 year
Part B: Safety and Tolerability in Terms of Adverse Events	Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters	At every treatment and follow up visit until disease progression, an average of 1 year.
Part B: Secondary Measures Change in Efficacy - Disease Control Rate	Disease control rate is confirmed complete response (CR), confirmed partial response (PR) and stable disease (SD)	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
Part B: Secondary Measures Change in Efficacy - Duration of Overall Response	Duration of overall response is according to RECIST 1.1 criteria measured from the time measurement criteria are first met for CR or PR, whichever is first recorded, until the first date that recurrent or PD is objectively documented (taking as reference for PD the smallest measurements recorded on study). DOR is only applied to treatment groups where at least one response patient was recorded.	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 48 months
Part B: Secondary Measures Change in Efficacy - PFS	progression-free survival (PFS): defined as the time from randomisation to the first documentation of PD as determined by the Investigator or death from any cause, whichever occurs first. Only includes progression events that occur within 126 days of the last evaluable assessment	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
Part B: Secondary Measures Change in Efficacy - OS	overall survival (OS) - defined as the time from treatment allocation to death from any cause	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 15 months
Part B: Secondary Measures Change in Efficacy - OS at 12 Months	proportion of patients alive at 12 months: the percentage of patients surviving at 12 months after randomization to study drug	Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months
Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA Level From Baseline	Percent STAT3 RNA change in expression level in peripheral blood in patients who had baseline (Screening or Day -7) sample for comparison. Data were only available for B1, B3, B5, B7 and B8.	At Cycle 2 Day 1 vs. Baseline
Part B: Evaluation of PDL1 Expression	Tumors with PDL1-positive tumor cells at the designated cutoff. Data were only available for B1, B2, B3, B4, B7 and B8.	in baseline tumor samples

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: MedImmune LLC
• Investigators: Principal Investigator: Dr David Hong, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• Related Info
• Related Info
• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2015
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): October 8, 2025

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimated): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: January 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Carcinoma of the Head and Neck
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents, Immunological; Antineoplastic Agents; durvalumab; tremelimumab; danvatirsen; N-(2-(2,3-difluoro-6-benzylthio)-6-(3,4-dihydroxybutan-2-yloxy)pyrimidin-4-yl)azetidine-1-sulfonamide
• Other Study ID Numbers: D5660C00004; 2015-002525-19 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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 de-identified 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 Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No