Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MedImmune LLC
With
GlaxoSmithKline
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must be able to provide informed consent
In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma that has relapsed and is refractory to standard therapy, or for which no standard therapy exists
In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or cytologically confirmed
Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and must not have received more than 2 prior chemotherapeutic regimens
Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV disease that is surgically incurable and unresectable
Melanoma patients with documented BRAF mutation that is known to be responsive to BRAF inhibitors must have failed or be intolerant to such inhibitors
Must have measurable disease
Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry
Must by at least 18 years old
Must have adequate organ function
You may not be if
Prior cancer therapies must have completed at least 14 days or 5 half-lives (whichever is longer) prior to first dose of AMP-224
Prior treatment with an anti-PD1 antibody therapy
Known antibody response against prior antibody therapy or fusion protein therapeutics
Major surgery within 4 weeks prior to first dose of AMP-224
Prior allogeneic or autologous bone marrow or organ transplantation
Known and/or a history or evidence of autoimmune disease except vitiligo, resolved childhood asthma and stable hypothyroidism
Received an immunomodulatory drug within 2 weeks of first dose of AMP-224
Active infections requiring antibiotics, physician monitoring, or recurrent fevers \>100.4 degrees fahrenheit associated with a clinical diagnosis of active infection
Patients with cirrhosis
Clinically significant cardiac or electrocardiogram abnormalities
History or evidence of HIV
Active viral disease (except when the viral infection is associated with the malignancy)
Regular use of illicit drugs or a recent history of substance abuse
