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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02499328
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Results First Posted : November 23, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck Drug: AZD9150 Drug: MEDI4736 Drug: AZD5069 Drug: tremelimumab (treme) Phase 1 Phase 2

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)

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : August 5, 2015
Actual Primary Completion Date : February 28, 2020
Estimated Study Completion Date : September 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736

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: AZD9150
AZD9150

Drug: MEDI4736
MEDI4736




Primary Outcome Measures :
  1. Part A: Danvatirsen With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion [ Time Frame: 35 days ]
    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.

  2. Part A: AZD5069 With Durvalumab MTDs (Maximum Tolerated Dose) or Recommended Doses for Dose-expansion [ Time Frame: 35 days ]
    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.

  3. Part A: Safety and Tolerability in Terms of Adverse Events [ Time Frame: At every treatment and follow up visit until disease progression, an average of 1 year. ]
    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

  4. Part B: ORR (Objective Response Rate) in Patients With IL/2L RM-SCCHN. [ Time Frame: Assessed at every even-numbered cycles with RECIST until disease progression, up to 12 months. ]
    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.


Secondary Outcome Measures :
  1. Part A and B: AZD9150 AUC0-6h at Lead in Day-7 [ Time Frame: Lead in day -7, AUC from time 0 to 6h (post dose). ]
    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.

  2. Part A and B: AZD9150 Cmax at Lead in Day -7 [ Time Frame: 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.

  3. Part A and B: AZD9150 AUC0-6h at Cycle 2 Day 1 [ Time Frame: Cycle 2 day 1, AUC from time 0 to 6 h post dose ]
    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.

  4. Part A and B: AZD9150 Cmax at Cycle 2 Day 1 [ Time Frame: Cycle 2 day 1 ]
  5. Part A and B: AZD5069 AUC0-12h at Lead in Day -7 [ Time Frame: Lead in day -7, AUC from time 0 to 12h post dose ]
    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.

  6. Part A and B: AZD5069 Cmax at Lead in Day -7 [ Time Frame: 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.

  7. Part A and B: AZD5069 Cssmax at Cycle 2 Day 1 [ Time Frame: 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.

  8. Part A and B: AZD5069 AUCss at Cycle 2 Day 1 [ Time Frame: 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.

  9. Part A and B: Durvalumab Cmax After Single Dose at Cycle 1 Day 1 [ Time Frame: Cycle 1 day 1 ]
  10. Part A and B: Durvalumab Ctrough After Multiple Doses at Cycle 4 Day 1 [ Time Frame: 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.

  11. Part A and B: Durvalumab Cmax After Multiple Doses at Cycle 8 Day 1 [ Time Frame: 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.

  12. Part A and B: Treme Cmax After Single Dose [ Time Frame: Cycle 1 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.

  13. Part A and B: Treme Ctrough After Multiple Doses at Cycle 4 Day 1 [ Time Frame: 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.

  14. Part A and B: Immunogenecity as Percent of ADA Positive Subjects [ Time Frame: Throughout the study, up to 3.3 years ]
    Subject was considered ADA positive if any post dose samples had ADA positive result. Result was not stratified based on post dose time points.

  15. Part A: Antitumour Activity in Monotherapy and Combination Arms of Study [ Time Frame: assessed at every even numbered cycle with RECIST until disease progression, an average of 1 year ]
    complete response, partial response, stable disease or progressive disease based on RECIST

  16. Part B: Safety and Tolerability in Terms of Adverse Events [ Time Frame: At every treatment and follow up visit until disease progression, an average of 1 year. ]
    Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

  17. Part B: Secondary Measures Change in Efficacy - Disease Control Rate [ Time Frame: Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months ]
    Disease control rate is confirmed complete response (CR), confirmed partial response (PR) and stable disease (SD)

  18. Part B: Secondary Measures Change in Efficacy - Duration of Overall Response [ Time Frame: Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 48 months ]
    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.

  19. Part B: Secondary Measures Change in Efficacy - PFS [ Time Frame: Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months ]
    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

  20. Part B: Secondary Measures Change in Efficacy - OS [ Time Frame: Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 15 months ]
    overall survival (OS) - defined as the time from treatment allocation to death from any cause

  21. Part B: Secondary Measures Change in Efficacy - OS at 12 Months [ Time Frame: Assessed at every even-numbered cycles. Assessed at every even numbered cycle with RECIST until disease progression, up to 12 months ]
    proportion of patients alive at 12 months: the percentage of patients surviving at 12 months after randomization to study drug

  22. Part B: Evaluation of AZD9150 Pharmacodynamics: Change in STAT3 RNA Level From Baseline [ Time Frame: At Cycle 2 Day 1 vs. 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.

  23. Part B: Evaluation of PDL1 Expression [ Time Frame: in baseline tumor samples ]
    Tumors with PDL1-positive tumor cells at the designated cutoff. Data were only available for B1, B2, B3, B4, B7 and B8.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02499328


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35294
United States, California
Research Site
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
United States, Colorado
Research Site
Denver, Colorado, United States, 80218
United States, Florida
Research Site
Plantation, Florida, United States, 33324
Research Site
Sarasota, Florida, United States, 34232
United States, Indiana
Research Site
Lafayette, Indiana, United States, 47905
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02111
United States, Michigan
Research Site
Detroit, Michigan, United States, 48201
United States, Montana
Research Site
Billings, Montana, United States, 59101
United States, New Jersey
Research Site
Morristown, New Jersey, United States, 07960
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45267-2827
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Virginia
Research Site
Fairfax, Virginia, United States, 22031
United States, Washington
Research Site
Seattle, Washington, United States, 98109
Belgium
Research Site
Antwerpen, Belgium, 2020
Research Site
Brussels, Belgium, 1000
Research Site
Bruxelles, Belgium, 1200
Research Site
Edegem, Belgium, 2650
Research Site
Namur, Belgium, 5000
Germany
Research Site
Berlin, Germany, 12200
Research Site
Dresden, Germany, 1307
Research Site
Frankfurt, Germany, 60488
Research Site
Hamburg, Germany, 20246
Research Site
Hannover, Germany, 30625
Research Site
Jena, Germany, 07743
Research Site
Köln, Germany, 50670
Research Site
München, Germany, 81675
Italy
Research Site
Milano, Italy, 20133
Spain
Research Site
Barcelona, Spain, 08035
Research Site
Hospitalet deLlobregat, Spain, 08907
Research Site
Madrid, Spain, 28040
Research Site
Madrid, Spain, 28041
Research Site
Toledo, Spain, 45004
United Kingdom
Research Site
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
Taunton, United Kingdom, TA1 5DA
Sponsors and Collaborators
AstraZeneca
MedImmune LLC
Investigators
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Principal Investigator: Dr David Hong, MD M.D. Anderson Cancer Center
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] November 20, 2019
Statistical Analysis Plan  [PDF] April 8, 2020

Additional Information:
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02499328    
Other Study ID Numbers: D5660C00004
First Posted: July 16, 2015    Key Record Dates
Results First Posted: November 23, 2021
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.
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.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Carcinoma of the Head and Neck
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Durvalumab
Tremelimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents