A Phase 1/2 Study to Evaluate MEDI4736


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Gerardo Colon-Otero, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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