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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 : Active, not recruiting
First Posted : July 21, 2015
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Tracking Information
First Submitted Date  ICMJE July 6, 2015
First Posted Date  ICMJE July 21, 2015
Last Update Posted Date June 30, 2021
Actual Study Start Date  ICMJE July 24, 2015
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumors
Intervention  ICMJE
  • Biological: MEDI9447
    Subjects will receive MEDI9447 until disease progression
  • Biological: MEDI9447 and MEDI4736
    Subjects will receive MEDI9447 and MEDI4736 until disease progression
Study Arms  ICMJE
  • Experimental: Monotherapy
    MEDI9447 (oleclumab) only
    Intervention: Biological: MEDI9447
  • Experimental: Combination
    MEDI9447 (oleclumab) and MEDI4736 (durvalumab)
    Intervention: Biological: MEDI9447 and MEDI4736
Publications * Hay CM, Sult E, Huang Q, Mulgrew K, Fuhrmann SR, McGlinchey KA, Hammond SA, Rothstein R, Rios-Doria J, Poon E, Holoweckyj N, Durham NM, Leow CC, Diedrich G, Damschroder M, Herbst R, Hollingsworth RE, Sachsenmeier KF. Targeting CD73 in the tumor microenvironment with MEDI9447. Oncoimmunology. 2016 Jul 11;5(8):e1208875. doi: 10.1080/2162402X.2016.1208875. eCollection 2016 Aug.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 11, 2021)
192
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2015)
108
Estimated Study Completion Date  ICMJE January 21, 2022
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 101 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Korea, Republic of,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503774
Other Study ID Numbers  ICMJE D6070C00001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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
Responsible Party MedImmune LLC
Study Sponsor  ICMJE MedImmune LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MedImmune LLC MedImmune LLC
PRS Account MedImmune LLC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP