Clinical trial · Interventional
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
NCT00112580CI-TRIAL-00054104completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR)
- timeFrame
- From first dose to 3 weeks following the end of the treatment cycle, up to 24 weeks.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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)References
Publications (1)
- RESULTRoyal 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. PMID 20842054