Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01693562 : A Phase 1/2 Study to Evaluate MEDI4736
PhasePhase 1/Phase 2
AgesMin: 18 Years Max: N/A
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 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)

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.

- 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 (excpet HCC patients)
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01693562      |      Link to official Clinicaltrials.gov listing
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