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|NCT01693562 : A Phase 1/2 Study to Evaluate MEDI4736|
|Phase||Phase 1/Phase 2|
|Ages||Min: 18 Years Max: N/A|
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 treatment.
- 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 samples (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
- 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 (excpet HCC patients)
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01693562
| Link to official Clinicaltrials.gov listing