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Phase 2 N=27 Treatment

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

Pancreatic Cancer

Enrolled (actual)
27
Serious AEs
74.1%
Results posted
Sep 2021
Primary outcome: Primary: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) — 0; 0 Percent of Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ipilimumab (Biological)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Bristol-Myers Squibb
Primary completion
Jun 2009

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
0; 0

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.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 3 months

Hematopoietic

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

Hepatic

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

Renal

  • Creatinine < 2.0 mg/dL

Immunologic

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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

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

Chemotherapy

  • 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

Radiotherapy

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

Surgery

  • See Disease Characteristics

Other

  • At least 3 weeks since other prior therapy for pancreatic adenocarcinoma and recovered
  • No concurrent immunosuppressants (e.g., cyclosporin or its analog)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00112580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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