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MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00112580
Recruitment Status : Completed
First Posted : June 3, 2005
Last Update Posted : October 12, 2015
National Cancer Institute (NCI)
Information provided by:
Bristol-Myers Squibb

June 2, 2005
June 3, 2005
October 12, 2015
July 2005
June 2009   (Final data collection date for primary outcome measure)
Clinical response (complete and partial)
Not Provided
Complete list of historical versions of study NCT00112580 on ClinicalTrials.gov Archive Site
Incidence of autoimmunity
Not Provided
Not Provided
Not Provided
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

RATIONALE: Biological therapies, such as MDX-010, may stimulate the immune system in different ways and stop tumor cells from growing.

PURPOSE: This phase II trial is studying how well MDX-010 works in treating patients with stage IV pancreatic cancer that cannot be removed by surgery.



  • Determine clinical response (partial and complete responses) in patients with unresectable stage IV (locally or distantly metastatic) pancreatic adenocarcinoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010).


  • Determine whether observed responses correlate with the incidence of autoimmunity in patients treated with this drug.

OUTLINE: This is an open-label study. Patients are stratified according to status of disease (locally vs distantly metastatic).

Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on days 0, 21, 42, and 63. Treatment repeats every 84 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after achieving a partial response or complete response receive 2 additional courses of therapy.

After completion of study treatment, patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 42-82 patients (21-41 per stratum) will be accrued for this study within 2-4 years.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Cancer
Biological: ipilimumab
Not Provided
Royal RE, Levy C, Turner K, Mathur A, Hughes M, Kammula US, Sherry RM, Topalian SL, Yang JC, Lowy I, Rosenberg SA. Phase 2 trial of single agent Ipilimumab (anti-CTLA-4) for locally advanced or metastatic pancreatic adenocarcinoma. J Immunother. 2010 Oct;33(8):828-33. doi: 10.1097/CJI.0b013e3181eec14c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2009
June 2009   (Final data collection date for primary outcome measure)


  • Histologically confirmed pancreatic adenocarcinoma

    • Stage IV disease

      • Locally (invasion of adjacent structures, including mesenteric arteries or organs) or distantly metastatic disease
    • Unresectable disease
    • Pancreatic adenocarcinoma with intraductal papillary mucinous neoplasm allowed
  • The following diagnoses are not allowed:

    • Acinar cell carcinoma
    • Pancreaticoblastoma
    • Malignant cystic neoplasms
    • Endocrine neoplasms
    • Squamous cell carcinoma
    • Vater and periampullary duodenal or common bile duct malignancies
  • Clinically evaluable disease with ≥ 1 site of measurable disease
  • Biliary or gastric outlet obstruction allowed provided it is effectively drained by endoscopic, operative, or interventional means
  • Pancreatic, biliary, or enteric fistulae allowed provided they are controlled with an appropriate drain



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months


  • WBC ≥ 2,500/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • Hematocrit ≥ 27%


  • Hepatitis B surface antigen negative
  • Hepatitis C virus antibody negative OR
  • Hepatitis C RNA negative by polymerase chain reaction


  • Creatinine < 2.0 mg/dL


  • HIV negative
  • No history of or active autoimmune disease, including uveitis or autoimmune inflammatory eye disease
  • No active uncontrolled infection


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
  • No underlying medical condition that would preclude study participation


Biologic therapy

  • No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010)


  • At least 3 weeks since prior chemotherapy for pancreatic adenocarcinoma and recovered
  • No concurrent chemotherapy

Endocrine therapy

  • More than 4 weeks since prior corticosteroids
  • No concurrent systemic or topical corticosteroids


  • At least 3 weeks since prior radiotherapy for pancreatic adenocarcinoma and recovered


  • See Disease Characteristics


  • At least 3 weeks since other prior therapy for pancreatic adenocarcinoma and recovered
  • No concurrent immunosuppressants (e.g., cyclosporin or its analog)
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Not Provided
Bristol-Myers Squibb
National Cancer Institute (NCI)
Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
Bristol-Myers Squibb
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP