| Eligibility |
Inclusion Criteria:
- Histologically or cytologically confirmed surgically resectable pancreatic ductal
adenocarcinoma, but not adenosquamous/squamous pancreas cancers (as determined by
operating surgeon or tumor board). Patients who have previously received chemotherapy
for his/her pancreas cancer within the past 6 months and who are now deemed resectable
are also eligible for this trial.
- At least 18 years of age.
- ECOG performance status = 1
- Normal bone marrow and organ function as defined below:
- Absolute neutrophil count = 1,500 /cumm
- Platelets = 100,000 /cumm
- Hemoglobin = 9.0 g/dL
- AST(SGOT)/ALT(SGPT) = 2.5 x IULN
- Creatinine clearance = 1.5 x IULN or glomerular filtration rate of = 60 mL/min
- INR = 1.5 x IULN unless patient is receiving anticoagulant therapy as long as INR
or PTT is within therapeutic range of intended use of anticoagulants
- aPTT = 1.5 x IULN unless patient is receiving anticoagulant therapy as long as
INR or PTT is within therapeutic range of intended use of anticoagulants
- Albumin = 3.0mg/dL
- The effects of CDX-301 and CDX-1140 on the developing human fetus are unknown. For
this reason, women of childbearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control, abstinence) prior to study
entry, for the duration of study participation, and for 3 months after the last dose
of either study drug. Should a woman become pregnant or suspect she is pregnant while
participating in this study or for 3 months after the last dose of either study drug,
she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
- Immune deficiencies such as HIV.
- A history of other malignancy with the exception of malignancies for which all
treatment was completed at least 2 years before registration and the patient has no
evidence of disease.
- Currently receiving any other investigational agents or has received any other
investigational agents within 4 weeks or 5 half-lives of the planned first dose of
study treatment.
- Receipt of chemotherapy within 2 weeks of planned first dose of study treatment.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to CDX-301 or CDX-1140 or other agents used in the study.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(for > 1 month of 10 mg prednisone daily, or equivalent) or any other form of
immunosuppressive therapy not routinely associated with chemotherapeutic regimen.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, immunosuppression, autoimmune conditions, or underlying pulmonary disease.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, immunosuppression, autoimmune conditions, or underlying pulmonary disease.
- Has an autoimmune disease requiring systemic treatment within the past 2 years (i.e.
with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a
form of systemic treatment.
- Known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive)
or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected).
- Has a history of (non-infectious) pneumonitis that required steroids or current
pneumonitis.
- Has a known history of active TB (bacillus tuberculosis).
- Major surgery within 28 days prior to the first study treatment.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
pregnancy test within 14 days of study entry.
- History of bone marrow or solid organ transplant.
- Patients with a history of myocardial infarction, cerebral vascular accident,
thrombosis or pulmonary embolus within 12 months prior to the first dose of study
treatment are excluded from this study.
- Patients with known mutations/amplifications in Flt3
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