MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
![]() |
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: NCT02503774 |
Recruitment Status :
Completed
First Posted : July 21, 2015
Last Update Posted : February 16, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Solid Tumors | Biological: MEDI9447 Biological: MEDI9447 and MEDI4736 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 192 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Multicenter, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors |
Actual Study Start Date : | July 24, 2015 |
Actual Primary Completion Date : | January 22, 2021 |
Actual Study Completion Date : | January 22, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Monotherapy
MEDI9447 (oleclumab) only
|
Biological: MEDI9447
Subjects will receive MEDI9447 until disease progression |
Experimental: Combination
MEDI9447 (oleclumab) and MEDI4736 (durvalumab)
|
Biological: MEDI9447 and MEDI4736
Subjects will receive MEDI9447 and MEDI4736 until disease progression |
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]The primary endpoint is safety as assessed by the presence of AEs, serious adverse events (SAEs).
- Composite measure of Preliminary antitumor activity [ Time Frame: From the time of informed consent through an average of 1 year ]Assessment of antitumor activity include OR, disease control (DC), duration of response (DoR), progression-free survival (PFS), and overall survival (OS).
- Composite measure of Pharmacokinetics of MEDI9447 or MEDI9447/MEDI4736 [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]Including Cmax and AUC of MEDI9447 administered as a single agent and the Cmax and AUC of both MEDI9447 and MEDI4736 when administered in combination.
- Composite measure of Immunogenicity [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]Immunogenicity of MEDI9447 and MEDI4736 include the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs).
- Biomarker activity [ Time Frame: From time of informed consent through 12 weeks after last dose of investigational product ]Assessment of target expression in subject samples.

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.
Ages Eligible for Study: | 18 Years to 101 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult subjects; age ≥ 18
- Written and signed informed consent must be obtained
- Have histologic or cytologic documentation of solid tumor including EGFR mutated (EGFRm) NSCLC
- Subjects must have at least 1 lesion that is measureable using RECIST guidelines
- Subjects must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies.
- Eastern Cooperative Oncology Group performance score of 0 or 1
- Adequate organ function
Exclusion Criteria:
- Prior treatment with tumor necrosis factor receptor superfamily agonists including OX40, CD27, CD137 (4-1BB), CD357 (GITR). One cohort also excludes anti CTLA-4, anti PDL-1 and anti PDL-1.
- Subjects who have received prior therapy with regimens containing CTLA-4, PD-L1, or PD-1 antagonists may be permitted to enroll under certain conditions
-
Cardiac or peripheral vascular disease meeting any of the following criteria:
- Past history of myocardial infarction in the prior 12 months
- Past history of stroke or transient ischemic attack requiring medical therapy
- Congestive heart failure ≥ Class 3 based on New York Heart Association Functional Classification
- Grade 3 or greater edema (eg, peripheral, pulmonary)
- History of Grade 3 or greater thromboembolic events in the prior 12 months
- Subjects with active tuberculosis are ineligible. In settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out
- Active or prior documented autoimmune or inflammatory disorders
- Untreated central nervous system (CNS) metastatic disease
- Known positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C
- Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement

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): NCT02503774
United States, California | |
Research Site | |
La Jolla, California, United States, 92093 | |
United States, Connecticut | |
Research Site | |
New Haven, Connecticut, United States, 06510 | |
United States, Florida | |
Research Site | |
Gainesville, Florida, United States, 32608 | |
United States, Georgia | |
Research Site | |
Atlanta, Georgia, United States, 30318 | |
United States, Missouri | |
Research Site | |
Saint Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Research Site | |
Durham, North Carolina, United States, 27705 | |
United States, Ohio | |
Research Site | |
Cincinnati, Ohio, United States, 45267 | |
Research Site | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Research Site | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Research Site | |
Dallas, Texas, United States, 75230 | |
Research Site | |
Houston, Texas, United States, 77584 | |
Australia | |
Research Site | |
Camperdown, Australia, 2050 | |
Research Site | |
Parkville, Australia, 3050 | |
Research Site | |
St Leonards, Australia, 2065 | |
Research Site | |
Woolloongabba, Australia, 4068 | |
Korea, Republic of | |
Research Site | |
Seoul, Korea, Republic of, 03080 | |
Research Site | |
Seoul, Korea, Republic of, 05505 | |
Research Site | |
Seoul, Korea, Republic of, 06351 |
Study Director: | MedImmune LLC | MedImmune LLC |
Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT02503774 |
Other Study ID Numbers: |
D6070C00001 |
First Posted: | July 21, 2015 Key Record Dates |
Last Update Posted: | February 16, 2021 |
Last Verified: | February 2021 |
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. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Solid Tumors, MEDI9447, oleclumab, MEDI4736, durvalumab, CD73, PD-L1, EGFRm NSCLC, immunotherapy, pancreatic, colorectal |
Neoplasms Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents |