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MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02503774
Recruitment Status : Recruiting
First Posted : July 21, 2015
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

July 6, 2015
July 21, 2015
July 11, 2018
July 24, 2015
December 7, 2020   (Final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT02503774 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
MEDI9447 Alone and in Combination With MEDI4736 in Adult Subjects With Select Advanced Solid Tumors
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
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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors
  • Biological: MEDI9447
    Subjects will receive MEDI9447 until disease progression
  • Biological: MEDI9447 and MEDI4736
    Subjects will receive MEDI9447 and MEDI4736 until disease progression
  • Experimental: Monotherapy
    MEDI9447 (oleclumab) only
    Intervention: Biological: MEDI9447
  • Experimental: Combination
    MEDI9447 (oleclumab) and MEDI4736 (durvalumab)
    Intervention: Biological: MEDI9447 and MEDI4736
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.
 
Recruiting
308
108
December 7, 2020
December 7, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 101 Years   (Adult, Older Adult)
No
Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com
Contact: AstraZeneca Cancer Study Locater Service 1-877-400-4656 AstraZeneca@emergingmed.com
Australia,   Korea, Republic of,   United States
 
 
NCT02503774
D6070C00001
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: AZ's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
URL: http://
MedImmune LLC
MedImmune LLC
Not Provided
Study Director: MedImmune LLC MedImmune LLC
MedImmune LLC
July 2018

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