Trial Search Results
A Phase 1/2 Study to Evaluate MEDI4736
MEDI4736 is an antibody that is made in the laboratory. MEDI4736 is an experimental drug being tested in humans for the first time. The main purpose of this study is to determine the dose of MEDI4736 that is safe and tolerable in subjects with solid tumors. This study will also evaluate how much MEDI4736 is in the blood at various times, whether the immune system becomes activated following treatment or the body produces antibodies against MEDI4736, as well as the effect MEDI4736 has on cancer.
Stanford is currently not accepting patients for this trial.
- Drug: MEDI4736
Phase 1/Phase 2
- 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
- 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
- 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
- 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)
Ages Eligible for Study
18 Years - 99 Years
Genders Eligible for Study