| Eligibility |
Inclusion Criteria:
- Patients with histopathologic or cytologic diagnosis of adenocarcinoma of the pancreas
(PDAC), or suspicious for malignancy per pathology, which is deemed BR or LA PDAC per
NCCN guidelines or following evaluation by a Multidisciplinary group of physicians.
- Patients must have received FOLFIRINOX for 3-6 months prior to enrollment with at
least stable disease by restaging imaging.
Note: SOC treatment regimen derived from FOLFIRINOX dose modifications are acceptable.
To maximize potential efficacy no more than a 6-week treatment break is recommended between
the completion of SOC chemotherapy (FOLFIRINOX) and initiation of study treatment
(durvalumab).
- Age = 18 years
- Body weight >30kg
- ECOG 0-2
- Patients must have normal organ and marrow function as defined below:
- Absolute Neutrophil Count (ANC) =1.0 K/mcL
- Platelets =75 K/mcL
- Hemoglobin = 9 g/dL
- Total bilirubin = 1.5 X upper limit of normal (ULN)
- AST(SGOT) and ALT(SGPT) = 2.5 X ULN
- Creatinine OR creatinine clearance = 1.5 times the upper limit of normal OR > 40
mL/min for patients with creatinine levels above normal.
Note: Patients with biliary stent are eligible provided that all other inclusion criteria
are met.
- Negative pregnancy test in women of childbearing potential (WOCBP) within 30 days of
durvalumab administration or evidence of post-menopausal status. Women will be
considered post-menopausal if they have been amenorrhoeic for 12 months without an
alternative medical cause or underwent surgical sterilization (bilateral oophorectomy
or hysterectomy).
- Non-sterilized male participants who are sexually active with a female partner of
childbearing potential must be willing to use a highly effective method of
contraception from Day 1 through 90 days after receipt of the final dose of
investigational product(s). Not engaging in sexual activity for the total duration of
the study and the drug washout period is an acceptable practice; however, occasional
abstinence, the rhythm method, and the withdrawal method are not acceptable methods of
contraception. Male participants must be willing to refrain from sperm donation
throughout these periods.
- Ability to understand and the willingness to sign an informed consent document.
- Willingness and ability to comply with the protocol including study treatment,
scheduled assessments and follow-up.
Exclusion Criteria:
- History of another primary malignancy except for:
°Malignancy treated with curative intent with no known active disease for 2 years
before the first dose of study drug and low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
disease
- Patients who have had prior anti-cancer treatment or are currently receiving
anti-cancer treatment for their disease other than chemotherapy as stipulated by
protocol.
- Women who are breastfeeding.
- Any clinically significant, unresolved toxicity >CTCAE grade 2 from previous
anti-cancer therapy with the exception of alopecia, vitiligo and laboratory values
defined in the inclusion criteria.
- Patients with Grade = 2 neuropathy will be included at the investigator's discretion
- Patients with irreversible toxicity not reasonably expected to be exacerbated by
treatment with durvalumab may be included at the nvestigator's discretion
- Patients who are currently receiving any other investigational agents for therapeutic
treatment of their primary cancer.
- Any previous treatment with a PD1 or PD-L1 inhibitor, including Durvalumab or other
immunotherapy.
- Known metastatic disease.
- Major surgical procedures based on clinical judgement of the investigator within 30
days prior to the first dose of study drug. Patients may undergo staging laparoscopy,
PTC placement, ERCP, etc. at any time which should not interfere with study treatment.
- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to durvalumab.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, interstitial lung disease, pneumonitis, symptomatic congestive heart
failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements.
- Patients who are receiving radiation treatment outside of the enrolling centers.
- Patients with frank transmural macroscopic invasion of duodenum by tumor as determined
by treating investigator.
- Active or prior documented autoimmune or inflammatory disorders (including
inflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis with the
exception of diverticulosis, celiac disease, irritable bowel syndrome, or other
serious gastrointestinal chronic conditions associated with diarrhea); systemic lupus
erythematosus; Wegener syndrome (granulomatosis with polyangiitis; Graves' disease;
rheumatoid arthritis, hypophysitis, uveitis, etc) within the past 3 years prior to the
start of treatment. The following are exceptions to this criterion: Patients with
vitiligo or alopecia. Patients with hypothyroidism (e.g., following Hashimoto
syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment
- Current or prior use of immunosuppressive medication within 28 days before treatment,
except with chemotherapy.
- History of organ transplant that requires use of immunosuppressive agents.
- History of active primary immunodeficiency.
- Receipt of live attenuated vaccination within 30 days prior to receiving durvalumab.
- Any condition that, in the opinion of the investigator, would interfere with
evaluation of study treatment or interpretation of patient safety or study results.
- Active infection including tuberculosis (clinical evaluation that includes clinical
history, physical examination and radiographic findings and TB testing in line with
local practices), active bleeding diatheses, hepatitis B (known positive HBV surface
antigen result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2
antibodies).
- Patient with known active Hepatitis (i.e. Hepatitis B or C).
- Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen
(HBsAg) result. Patients with a past or resolved HBV infection (defined as the
presence of hepatitis B core antibody and absence of HBsAg and PCR negative) are
eligible.
- Patients positive for hepatitis C virus (HCV) antibody are eligible only if
polymerase chain reaction is negative for HCV RNA.
- Patients with macroscopic invasion of the bowel or stomach submucosa by primary
pancreatic tumor as determined by PI.
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