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Ipilimumab and Gemcitabine for Advanced Pancreas Cancer: A Phase Ib Study

Phase 1
18 Years
Open (Enrolling)
Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

Ipilimumab and Gemcitabine for Advanced Pancreas Cancer: A Phase Ib Study

OUTLINE: This is a dose-escalation study of ipilimumab.

INDUCTION: Patients receive ipilimumab intravenously (IV) over 90 minutes in weeks 1, 4, 7,
and 10, and gemcitabine hydrochloride IV over 30 minutes in weeks 1-7 and 9-11.

MAINTENANCE: Beginning in week 22, patients receive ipilimumab IV over 90 minutes once every
12 weeks and gemcitabine hydrochloride IV over 30 minutes once weekly for 3 weeks. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment modifications may apply according to response.

After completion of study treatment, patients are followed up monthly for 6 months and then
every 3 months.

Inclusion Criteria:

- Willing and able to give written informed consent

- Histologic or cytologic diagnosis of pancreas adenocarcinoma advanced or recurrent
(stage III or IV) that is unresectable; histologic or cytologic pathology from any
prior surgery is sufficient for diagnosis

- Must have measurable disease by modified WHO criteria

- White blood cells (WBC) >= 2000/uL

- Absolute neutrophil count (ANC) >= 1500/uL

- Platelets >= 100 x 10^3/uL

- Hemoglobin >= 9 g/dL (>= 80 g/L; may be transfused)

- Creatinine =< 2.0 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN

- Bilirubin =< 2.0 x ULN, (except patients with Gilbert's Syndrome, who must have a
total bilirubin less than 3.0 mg/dL)

- No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B,
or hepatitis C

- Performance status: Eastern Cooperative Oncology Group (ECOG) 0-1

- Prior systemic therapy for advanced pancreas cancer with gemcitabine is prohibited;
prior gemcitabine with radiotherapy for localized pancreas cancer is allowed provided
disease is present outside of the radiated field; prior gemcitabine as adjuvant
therapy to surgical resection is allowed provided 3 months or greater has elapsed
between the last dose of gemcitabine and the detection of recurrent disease

- Women of childbearing potential (WOCBP) must be using an adequate method of
contraception to avoid pregnancy throughout the study and for up to 26 weeks after
the last dose of investigational product, in such a manner that the risk of pregnancy
is minimized; WOCBP include any female who has experienced menarche and who has not
undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as:
amenorrhea >= 12 consecutive months without another cause, or for women with
irregular menstrual periods and taking hormone replacement therapy (HRT), a
documented serum follicle stimulating hormone (FSH) level >= 35 mIU/mL; women who are
using oral contraceptives, other hormonal contraceptives (vaginal products, skin
patches, or implanted or injectable products), or mechanical products such as an
intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent
pregnancy, or are practicing abstinence or where their partner is sterile (eg,
vasectomy) should be considered to be of childbearing potential

- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L
or equivalent units of human chorionic gonadotrophin [HCG]) within 72 hours before
the start of ipilimumab

- Men of fathering potential must be using an adequate method of contraception to avoid
conception throughout the study (and for up to 26 weeks after the last dose of
investigational product) in such a manner that the risk of pregnancy is minimized

- Patients on stable anticoagulation are eligible for enrollment; for patients on
warfarin, prothrombin time (PT)/international normalized ratio (INR) should be
monitored every 2 weeks during induction therapy, monthly thereafter, or more
frequent as clinically indicated

Exclusion Criteria:

- Any other malignancy from which the patient has been disease-free for less than 5
years, with the exception of adequately treated and cured basal or squamous cell skin
cancer, superficial bladder cancer or carcinoma in situ of the cervix

- Autoimmune disease: Patients with a history of inflammatory bowel disease, including
ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients
with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive
sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg,
Wegener's Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g.
Guillain-Barre Syndrome and Myasthenia Gravis)

- Any underlying medical or psychiatric condition, which in the opinion of the
investigator will make the administration of ipilimumab hazardous or obscure the
interpretation of adverse events (AEs), such as a condition associated with frequent

- Any non-oncology vaccine therapy used for prevention of infectious diseases (for up
to 1 month before or after any dose of ipilimumab)

- A history of prior treatment with ipilimumab or prior tumor necrosis factor receptor
superfamily, member 9 (CD137) agonist or cytotoxic T-lymphocyte-associated protein 4
(CTLA4) inhibitor or agonist

- Concomitant therapy with any of the following: interleukin (IL)2, interferon, or
other non-study immunotherapy regimens; immunosuppressive agents; other investigation
therapies; or chronic use of systemic corticosteroids

- WOCBP who are unwilling or unable to use an acceptable method of contraception to
avoid pregnancy for their entire study period and for at least 8 weeks after
cessation of study drug, or have a positive pregnancy test at baseline, or are
pregnant or breastfeeding

- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for
treatment of either a psychiatric or physical (eg, infectious) illness

- Patients with symptoms of partial or complete bowel obstruction and recent (within 6
month) history of fistula, intra-abdominal abscess or bowel perforation

- Patients with a history or evidence of central nervous system (CNS) disease,
including brain tumor, seizures not controlled with standard medical therapy or any
brain metastases

- Patients currently receiving radiation therapy or those having received radiation
within 4 weeks of study entry

- Patients with any known active infection or known history of tuberculosis

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

MTD of ipilimumab when given with gemcitabine hydrochloride in the treatment of pancreas adenocarcinoma

Outcome Description:

Dose limiting toxicity (DLT) will be monitored by calculating the Bayesian predictive probability of a DLT given the data to date. All toxicities will be summarized in a descriptive manner as to type, frequency, attribution and timing by dose level. Safety will be evaluated for all treated patients using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0.

Outcome Time Frame:

After the 12 weeks of induction therapy

Safety Issue:


Principal Investigator

Mary Mulcahy

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University


United States: Food and Drug Administration

Study ID:

NU 10I02



Start Date:

April 2012

Completion Date:

April 2018

Related Keywords:

  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms



Northwestern UniversityChicago, Illinois  60611