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A Phase 1 / 2 Study to Evaluate MEDI4736

Trial Status: Complete

This is a multicenter, open-label, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid tumors followed by an expansion phase in patients with advanced solid tumors. An exploration cohort has been added to determine the safety using Q4W dosing.

Inclusion Criteria

  • Age 18 or older.
  • In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists.
  • In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, subjects must have failed, be intolerant to, be ineligible for, or have refused
  • Eastern Cooperative Oncology Group (ECOG) status of 0 or 1.
  • Adequate organ and marrow function.
  • Subjects must have at least 1 measurable lesion.
  • Available archived tumor tissue sample.
  • Willingness to provide consent for biopsy sample (dose-expansion only)

Exclusion Criteria

  • Any prior Grade ≥ 3 irAE while receiving immunotherapy
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment.
  • Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors.
  • Active or prior documented autoimmune disease within the past 2 years
  • History of primary immunodeficiency
  • History of organ transplant that requires use of immunosuppressives
  • Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment
  • Other invasive malignancy within 2 years
  • Women who are pregnant or lactating
  • Uncontrolled intercurrent illness
  • Known history of tuberculosis
  • Known to be human immunodeficiency virus (HIV) positive
  • Known to be Hepatitis B or C positive (except HCC patients)

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: COMPLETED
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
UCSF Medical Center-Parnassus
Status: CLOSED_TO_ACCRUAL

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL
Tampa
Moffitt Cancer Center
Status: COMPLETED

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: WITHDRAWN

Illinois

Chicago
University of Chicago Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Maryland

Baltimore
Johns Hopkins University / Sidney Kimmel Cancer Center
Status: CLOSED_TO_ACCRUAL
University of Maryland / Greenebaum Cancer Center
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: COMPLETED

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

New York

Bronx
Montefiore Medical Center-Weiler Hospital
Status: CLOSED_TO_ACCRUAL
New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: COMPLETED
Columbus
Ohio State University Comprehensive Cancer Center
Status: COMPLETED

Pennsylvania

Philadelphia
Thomas Jefferson University Hospital
Status: ADMINISTRATIVELY_COMPLETE

Texas

Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL
San Antonio
University of Texas Health Science Center at San Antonio
Status: COMPLETED

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: CLOSED_TO_ACCRUAL

A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 (PD-L1)) will evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4736 in adult patients with solid tumors. A dose exploration cohort will look at the safety profile of Q4W dosing of MEDI4736.

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
MedImmune Inc

  • Primary ID CD-ON-MEDI4736-1108
  • Secondary IDs NCI-2012-02062
  • Clinicaltrials.gov ID NCT01693562