Phase 2
N=27
MDX-010 in Treating Patients With Stage IV Pancreatic Cancer That Cannot Be Removed By Surgery
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00112580 ↗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
| Outcome | Result | p-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)
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.