A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies (Soundtrack-E)

August 11, 2026 updated by: AstraZeneca

A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies.

This master study currently includes 3 substudies and each substudy focusing on a defined population:

Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US)

The study will have the following sequential periods:

  1. Screening period of 28 days
  2. Treatment period
  3. Follow-up period

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Heidelberg, Australia, 3084
        • Recruiting
        • Research Site
      • Melbourne, Australia, 3004
        • Recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Recruiting
        • Research Site
  • China
      • Beijing, China, 100044
        • Recruiting
        • Research Site
      • Guangzhou, China, 510060
        • Recruiting
        • Research Site
      • Jinan, China, 250013
        • Withdrawn
        • Research Site
      • Tianjin, China, 300060
        • Recruiting
        • Research Site
      • Zhengzhou, China, 450008
        • Recruiting
        • Research Site
  • Czechia
      • Ostrava - Poruba, Czechia, 708 52
        • Recruiting
        • Research Site
      • Prague, Czechia, 12808
        • Recruiting
        • Research Site
      • Praha 2 - Nové Město, Czechia, 12820
        • Recruiting
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Recruiting
        • Research Site
      • Aarhus N, Denmark, 8200
        • Recruiting
        • Research Site
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Research Site
      • Odense C, Denmark, 5000
        • Recruiting
        • Research Site
  • France
      • Clermont-Ferrand, France, 63000
        • Not yet recruiting
        • Research Site
      • Montpellier, France, 34295
        • Recruiting
        • Research Site
      • Paris, France, 75010
        • Recruiting
        • Research Site
      • Saint-Cloud, France, 92210
        • Recruiting
        • Research Site
      • Villejuif, France, 94805
        • Recruiting
        • Research Site
  • Germany
      • Cologne, Germany, 50937
        • Not yet recruiting
        • Research Site
      • Homburg, Germany, 66421
        • Not yet recruiting
        • Research Site
      • Kiel, Germany, 24105
        • Recruiting
        • Research Site
      • Mainz, Germany, 55131
        • Not yet recruiting
        • Research Site
      • München, Germany, 81377
        • Recruiting
        • Research Site
      • Würzburg, Germany, 97080
        • Recruiting
        • Research Site
  • Italy
      • Bologna, Italy, 40138
        • Not yet recruiting
        • Research Site
      • Milan, Italy, 20141
        • Not yet recruiting
        • Research Site
  • Japan
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Matsuyama, Japan, 791-0280
        • Recruiting
        • Research Site
      • Nagoya, Japan, 464-8681
        • Recruiting
        • Research Site
  • South Korea
      • Busan, South Korea, 48108
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Research Site
      • Seoul, South Korea, 02841
        • Recruiting
        • Research Site
  • Spain
      • Barcelona, Spain, 8036
        • Recruiting
        • Research Site
      • Madrid, Spain, 28034
        • Recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Recruiting
        • Research Site
      • Palma de Mallorca, Spain, 7120
        • Recruiting
        • Research Site
      • Santiago de Compostela, Spain, 15706
        • Recruiting
        • Research Site
      • Valencia, Spain, 46026
        • Recruiting
        • Research Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Research Site
      • Tainan, Taiwan, 710
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 100
        • Recruiting
        • Research Site
  • United Kingdom
      • Derriford, United Kingdom, PL6 5FP
        • Recruiting
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Research Site
      • Oxford, United Kingdom, 0X3 7LJ
        • Recruiting
        • Research Site
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • Research Site
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Research Site
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Research Site
    • New York
      • New York, New York, United States, 10065
        • Withdrawn
        • Research Site
      • New York, New York, United States, 10029
        • Recruiting
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Research Site
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Master Inclusion Criteria applicable to all substudies:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Contraception use during treatment and at least 90 days after final dose.
  • Confirmed CD19 expression if prior anti-CD19 therapy.

Substudy 1 Specific Inclusion Criteria:

  • Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
  • SLL: at least 1 measurable site per Lugano.
  • Absolute lymphocyte count (ALC) <25000 cells/mcL.
  • Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
  • Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.

Substudy 2 Specific Inclusion Criteria:

  • MCL diagnosis per WHO.
  • Clinical Stage II, III, or IV by Ann Arbor Classification.
  • At least 1 measurable site per Lugano.
  • ALC < 25000 cells/mcL.
  • Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.

Substudy 3 Specific Inclusion Criteria:

  • At least 1 measurable site as per Lugano.
  • Left ventricular ejection fraction (LVEF) ≥50%.
  • Participant must be no older than 79 years of age at the time of signing ICF.
  • Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.

  • Cohort 3A:

    1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
    2. R/R B-NHL after at least 1 prior lines of systemic therapy.
    3. International Prognostic Index (IPI) 2-5.

  • Cohort 3B:

    1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
    2. IPI score of 2 to 5.

Exclusion Criteria:

Master Exclusion Criteria applicable to all substudies:

  • Central nervous system (CNS) lymphoma.
  • Surgery within 14 days of study drug.
  • Clinically significant cardiovascular (CV) disease.
  • Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
  • Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
  • Radiation therapy within 28 days.
  • Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
  • Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
  • Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
  • Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).

Substudy 1 Specific Exclusion Criteria:

  • CLL/SLL transformation to more aggressive form of lymphoma.
  • Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.

Substudy 3 Specific Exclusion Criteria:

  • Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
  • Cumulative dose of anthracycline >150 mg/m2.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)
Participants will receive surovatamig monotherapy as subcutaneous (SC) injection.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)
Participants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
Drug: Acalabrutinib
Acalabrutinib will be administered orally
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)
Participants will receive surovatamig monotherapy as intravenous (IV) infusion.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)
Participants will receive surovatamig monotherapy as SC injection.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)
Participants will receive surovatamig monotherapy as IV infusion.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)
Participants will receive surovatamig as IV infusion with a 2SUD (double step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Drug: Rituximab
Rituximab will be administered as IV infusion as per standard of care.
Drug: Cyclophosphamide
Cyclophosphamide will be administered as IV infusion as per standard of care.
Drug: Vincristine
Vincristine will be administered as IV infusion as per standard of care.
Drug: Doxorubicin
Doxorubicin will be administered as IV infusion as per standard of care.
Drug: Prednisone (or equivalent)
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486
Experimental: Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)
Participants will receive surovatamig as IV infusion with a 3SUD (triple step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
Drug: Rituximab
Rituximab will be administered as IV infusion as per standard of care.
Drug: Cyclophosphamide
Cyclophosphamide will be administered as IV infusion as per standard of care.
Drug: Vincristine
Vincristine will be administered as IV infusion as per standard of care.
Drug: Doxorubicin
Doxorubicin will be administered as IV infusion as per standard of care.
Drug: Prednisone (or equivalent)
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Drug: Surovatamig
Surovatamig will be administered as either SC injection or IV infusion.
Other Names:
  • TNB-486
  • AZD0486

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Time Frame: Up to 6 years 4 months
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Up to 6 years 4 months
Number of Participants with Dose Limiting Toxicity (DLTs)
Time Frame: Up to 2 months
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Up to 2 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Response (CR) Rate
Time Frame: Up to 6 years 4 months
CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Up to 6 years 4 months
Duration of Response (DoR)
Time Frame: Up to 6 years 4 months
DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).
Up to 6 years 4 months
Overall Response Rate (ORR)
Time Frame: Up to 6 years 4 months
ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving either PR or CR based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Up to 6 years 4 months
Maximum Observed Concentration (Cmax)
Time Frame: Up to 90 days after last dose
The PK (Cmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Area Under the Concentration-time Curve (AUC)
Time Frame: Up to 90 days after last dose
The PK (AUC) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Minimum Observed Concentration (Cmin)
Time Frame: Up to 90 days after last dose
The PK (Cmin) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Time to Reach Maximum Concentration (tmax)
Time Frame: Up to 90 days after last dose
The PK (tmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Trough Plasma Concentration (Ctrough)
Time Frame: Up to 90 days after last dose
The PK (Ctrough) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Half Life (t1/2) of surovatamig
Time Frame: Up to 90 days after last dose
The PK (t1/2) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Clearance (CL) of surovatamig
Time Frame: Up to 90 days after last dose
The PK (CL) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose
Number of Participants with Anti-drug Antibody (ADA) for surovatamig
Time Frame: Up to 90 days after last dose
The incidence of immunogenicity of SC surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Up to 90 days after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 11, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D7407C00001
  • 2024-515034-33-00 (Registry Identifier: EU CT)

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 there quest portal Vivli.org. All requests 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 approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer 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 anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings