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

Study 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 Participants with Select Advanced Solid Tumors

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedOleclumab and Durvalumab

The study team can explain what participation involves.

Who it may be forSolid Tumors

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 11, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 1

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?MedImmune LLC

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: MedImmune LLC
Interventions being studied: Drug: Oleclumab; Drug: Durvalumab

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Adult participants; age ≥ 18
Written and signed informed consent must be obtained
Have histologic or cytologic documentation of solid tumor including EGFRm NSCLC
Participants must have at least 1 lesion that is measurable using RECIST guidelines
Participants 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

Reasons someone may not be able to joinExclusion 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, PD-L1, and anti PD-L1.
Participants 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
Participants 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Research SiteLa Jolla, California
Research SiteNew Haven, Connecticut
Research SiteGainesville, Florida
Research SiteAtlanta, Georgia
Research SiteSt Louis, Missouri
Research SiteDurham, North Carolina
Research SiteCincinnati, Ohio
Research SiteColumbus, Ohio
Research SiteNashville, Tennessee
Research SiteDallas, Texas
Research SiteHouston, Texas
Research SiteCamperdown

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 11, 2023. Always confirm current availability with the study team.

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