| Eligibility |
Inclusion Criteria:
- Capable of giving written informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in this
protocol. Written informed consent includes any locally required authorization (e.g.,
Health Insurance Portability and Accountability Act in the US, European Union [EU]
Data Privacy Directive in the EU) obtained from the patient/legal representative prior
to performing any protocol-related procedures, including screening evaluations
- Age >= 18 years at time of study entry
- Has histologically or cytologically confirmed resectable or borderline resectable
pancreatic adenocarcinoma per MD Anderson criteria (borderline patients based upon
reconstructable superior mesenteric vein/portal vein [SMV/PV] involvement or
reconstructable hepatic artery involvement are allowed)
- Has received no prior anti-cancer therapy for pancreatic adenocarcinoma
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin >= 9.0 g/dL
- Absolute neutrophil count 1.5 x (>= 1500 per mm^3)
- Platelet count >=100 x 10^9/L (>= 100,000 per mm^3)
- Serum bilirubin =< 1.5 x institutional upper limit of normal (ULN). This will not
apply to patients with confirmed Gilbert's syndrome (persistent or recurrent
hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or
hepatic pathology), who will be allowed only in consultation with their physician.
Subjects requiring biliary decompression, biliary stent, or drainage using
percutaneous trans-hepatic cholangiogram are allowed (patients with a declining
bilirubin status post stent placement are eligible with serum bilirubin =< 2.5 x
institutional ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) /
alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x
institutional ULN
- Measured creatinine clearance (CL) > 40 mL/min or calculated creatinine CL> 40 mL/min
by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine
collection for determination of creatinine clearance
- Has evidence of post-menopausal status or negative urinary- or serum pregnancy test
for female, pre-menopausal patients. Women will be considered post-menopausal if they
have been amenorrhoeic for 12 months without an alternative medical cause. The
following age-specific requirements apply:
- Women < 50 years of age would be considered post-menopausal if they have been
amenorrhoeic for 12 months or more following cessation of exogenous hormonal
treatments and if they have luteinizing hormone and follicle-stimulating hormone
levels in the post-menopausal range for the institution or if they underwent
surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women >= 50 years of age would be considered post-menopausal if they have been
amenorrhoeic for 12 months or more following cessation of all exogenous hormonal
treatments, had radiation-induced menopause with last menses >1 year ago, had
chemotherapy-induced menopause with last menses > 1 year ago, or underwent
surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or
hysterectomy)
- Is willing and able to comply with the protocol for the duration of the study
including undergoing treatment and scheduled visits and examinations including
follow-up
- Must have a predicted life expectancy of at least 6 months
- Is willing to undergo mandatory research esophagogastroduodenoscopy/endoscopic
ultrasound for fine-needle aspiration (exceptions to this eligibility can be discussed
with principal investigator [PI] and will be considered on a case-by-case basis)
- Has body weight of > 35 kg
Exclusion Criteria:
- Participated in another clinical study with an investigational product during the last
4 weeks from the first dose of this study's treatment
- May need preoperative radiation therapy (as determined per the treating medical team:
medical oncologist and/or surgical oncologist at time of study enrollment)
- Is concurrently enrolled in another clinical study (patient is eligible if the study
is an observational (non interventional) study or if enrollment is during the
follow-up period of an interventional study
- Has definitive evidence of metastatic disease per radiographic assessment
- Is receiving any concurrent chemotherapy, investigational product (IP), or biologic-
or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for
non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
- Had a major surgical procedure within 28 days prior to the first dose of IP (PORT
placement does not count; if classification is uncertain, discuss with PI)
- Has history of allogenic organ transplantation
- Has an active or previously documented autoimmune or inflammatory disorder (including
inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis
[diverticulosis is not an excluding factor], systemic lupus erythematosus, Sarcoidosis
syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease,
rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to
this criterion (and do not exclude patients from participation):
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on
hormone replacement
- Patients having any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years (allowed only after
consultation with the study physician)
- Patients with celiac disease controlled by diet alone
- Has uncontrolled intercurrent illness, including but not limited to, ongoing or active
infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable
angina pectoris; cardiac arrhythmia; interstitial lung disease; serious chronic
gastrointestinal conditions associated with diarrhea; or psychiatric illness/social
situations that would limit compliance with study requirements, would substantially
increase risk of incurring adverse events (AEs), or would compromise the ability of
the patient to give written informed consent
- Has a history of another primary malignancy. Patients having the following are still
eligible:
- Malignancy treated with curative intent, no known active disease >= 5 years
before the first dose of IP, and low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease
- Adequately treated carcinoma in situ without evidence of disease
- Has a history of leptomeningeal carcinomatosis
- Has a history of active primary immunodeficiency
- Has active infection including tuberculosis (clinical evaluation that includes
clinical history, physical examination and radiographic findings, and tuberculosis
[TB] testing in line with local practice), hepatitis B (known positive hepatitis B
virus [HBV] surface antigen [HBsAg] result), or hepatitis C. Patients with a past or
resolved HBV infection (defined as the presence of hepatitis B core antibody
[anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C
(hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is
negative for HCV ribonucleic acid (RNA)
- Is currently using or previously used immunosuppressive medication within 14 days
before the first dose of durvalumab. The following medications are exceptions to this
criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra
articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., computed
tomography [CT] scan premedication)
- Has received live attenuated vaccine within 30 days prior to the first dose of IP.
Note: patients, if enrolled, should not receive live vaccine while receiving IP or
during the 30 days after the last dose of IP
- Is a female and pregnant or breastfeeding; or is a male or female of reproductive
potential who is not willing to employ effective birth control from time of screening
to 90 days after the last dose of durvalumab and oleclumab monotherapy
- Has a known allergy or hypersensitivity to any of the study drugs or any of the study
drug excipients
- Previously received clinical-trial treatment with durvalumab or oleclumab regardless
of treatment arm assignment
- Has laboratory evidence of hypercalcemia (>= 11 mg/dL [in presence of normal albumin])
and/or hyperphosphatemia (>= 5.5 mg/dL)
- Has a history of venous thrombosis within the past 3 months prior to scheduled first
dose of study treatment and is not receiving fully dosed anticoagulation; or has
symptomatic venous thrombosis and symptoms have not improved
- Has a prior history of myocardial infarction, transient ischemic attack, or stroke
within the past 3 months prior to the scheduled first dose of study treatment
- Is unsuitable to participate in the study or is unlikely to comply with study
procedures, restrictions and requirements (per judgment by the investigator)
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