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.

Lead Sponsor:

MedImmune LLC

Intervention(s):

  • Drug: MEDI4736

Phase:

Phase 1/Phase 2

Eligibility


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)

Ages Eligible for Study

18 Years - 99 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting