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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

NCT ID: NCT02499328

Last Updated: 2025-11-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-06

Study Completion Date

2025-10-08

Brief Summary

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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

Detailed Description

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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)

Conditions

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Advanced Solid Tumors & Metastatic Squamous Cell Carcinoma of the Head and Neck

Keywords

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Carcinoma of the Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A1: AZD9150 / MEDI4736

Patients allocated in cohort of arm A1 (AZD9150/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

Part A2: AZD5069 / MEDI4736

Patients allocated in cohort of arm A2 (AZD5069/MEDI4736 will be evaluated for DLT until an MTD is achieved.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

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.

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

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.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

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.

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

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.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

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

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

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

Group Type EXPERIMENTAL

AZD5069

Intervention Type DRUG

AZD5069

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

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

Part A4: AZD9150/Treme/MEDI4736

Patients allocated in cohort of arm A4 (AZD9150/treme/MEDI4736) will be evaluated for DLT and MTD

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

tremelimumab (treme)

Intervention Type DRUG

tremelimumab

Part A5: AZD5069/Treme/MEDI4736

Patients allocated in cohort of arm A5 (AZD5069/treme/MEDI4736) will be evaluated for DLT and MTD.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

tremelimumab (treme)

Intervention Type DRUG

tremelimumab

Part A6: AZD9150/MEDI4736

Patients allocated in cohort of arm A6 (AZD9150/MEDI4736) will be evaluated for safety, PK and PD.

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

Part A7: AZD5069/MEDI4736

Patients allocated in cohort of arm A7 (AZD5069/MEDI4736) will be evaluated for safety, PK and PD.

Group Type EXPERIMENTAL

MEDI4736

Intervention Type DRUG

MEDI4736

AZD5069

Intervention Type DRUG

AZD5069

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

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

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

Group Type EXPERIMENTAL

AZD9150

Intervention Type DRUG

AZD9150

MEDI4736

Intervention Type DRUG

MEDI4736

Interventions

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AZD9150

AZD9150

Intervention Type DRUG

MEDI4736

MEDI4736

Intervention Type DRUG

AZD5069

AZD5069

Intervention Type DRUG

tremelimumab (treme)

tremelimumab

Intervention Type DRUG

Eligibility Criteria

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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
* 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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr David Hong, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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Research Site

Birmingham, Alabama, United States

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Duarte, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Denver, Colorado, United States

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Plantation, Florida, United States

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Sarasota, Florida, United States

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Lafayette, Indiana, United States

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Boston, Massachusetts, United States

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Detroit, Michigan, United States

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Billings, Montana, United States

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Morristown, New Jersey, United States

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Cincinnati, Ohio, United States

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Houston, Texas, United States

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Fairfax, Virginia, United States

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Seattle, Washington, United States

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Antwerp, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Namur, , Belgium

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Berlin, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Frankfurt, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Jena, , Germany

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München, , Germany

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Milan, , Italy

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Barcelona, , Spain

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Hospitalet deLlobregat, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Toledo, , Spain

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Birmingham, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Surrey, , United Kingdom

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Taunton, , United Kingdom

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Countries

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Canada United States Belgium Germany Italy Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5660C00004&attachmentIdentifier=6196e810-bbae-4179-a8b2-f9d0b2f5b623&fileName=d5660c00004-sap-V4.0_Redacted_PDFA.pdf&versionIdentifier=

Related Info

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5660C00004&attachmentIdentifier=94d1da6c-8b9b-48d3-9ff9-106e83189cc4&fileName=d5660c00004-csp-v12-amendment-11_-_Redacted_03Feb2021.pdf&versionIdentifier=

Related Info

Other Identifiers

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2015-002525-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D5660C00004

Identifier Type: -

Identifier Source: org_study_id