A Phase 1 / 2 Study to Evaluate MEDI4736
- 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)
- 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)
District of Columbia
Salt Lake City
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
- Primary ID CD-ON-MEDI4736-1108
- Secondary IDs NCI-2012-02062
- Clinicaltrials.gov ID NCT01693562