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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00112580
Recruitment Status : Completed
First Posted : June 3, 2005
Results First Posted : September 27, 2021
Last Update Posted : September 27, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: ipilimumab Phase 2

Detailed Description:



  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Single Agent Ipilimumab (MDX-010 Anti CTLA-4) for Subjects With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Actual Study Start Date : July 31, 2005
Actual Primary Completion Date : June 30, 2009
Actual Study Completion Date : June 30, 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Primary Outcome Measures :
  1. Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [ Time Frame: From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks. ]
    Percentage of participants who achieved Complete Response (CR) or Partial Response (PR) according to RECIST criteria. Particularly, CR is defined as disappearance of all target lesions, while PR is defined as at least a 30% decrease n the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00112580

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182
NCI - Surgery Branch
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Bristol-Myers Squibb
National Cancer Institute (NCI)
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Principal Investigator: Steven A. Rosenberg, MD, PhD NCI - Surgery Branch
  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:
Study Protocol  [PDF] March 24, 2005
Statistical Analysis Plan  [PDF] January 6, 2009

Publications of Results:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00112580    
Obsolete Identifiers: NCT00108888
Other Study ID Numbers: CDR0000430666
First Posted: June 3, 2005    Key Record Dates
Results First Posted: September 27, 2021
Last Update Posted: September 27, 2021
Last Verified: September 2021
Keywords provided by Bristol-Myers Squibb:
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action