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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
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Brief Summary:
The purpose of this study is 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

Condition or disease Intervention/treatment Phase
Solid Tumors Biological: MEDI9447 Biological: MEDI9447 and MEDI4736 Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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).

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 101 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02503774


Locations
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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
Sponsors and Collaborators
MedImmune LLC
Investigators
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Study Director: MedImmune LLC MedImmune LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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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 MedImmune LLC:
Solid Tumors, MEDI9447, oleclumab, MEDI4736, durvalumab, CD73, PD-L1, EGFRm NSCLC, immunotherapy, pancreatic, colorectal
Additional relevant MeSH terms:
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Neoplasms
Durvalumab
Antineoplastic Agents, Immunological
Antineoplastic Agents