Clinical trialPhase 1Completed
Ipilimumab +/- Vaccine Therapy in Treating Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer
A Phase Ib Trial Evaluating the Safety and Feasibility of Ipilimumab (BMS-734016) Alone or in Combination With Allogeneic Pancreatic Tumor Cells Transfected With a GM-CSF Gene for the Treatment of Locally Advanced, Unresectable or Metastatic Pancreatic Adenocarcinoma
- Outcome
- Outcome unknown
- Phase
- Phase 1
- Status
- Completed
- Study type
- Interventional
- Start
- February 2009
- Expected end
- July 2012
- Enrollment
- 30 participants
- Sites
- 1
- Primary outcomes
- Percent of Patients Experiencing an Unacceptable Toxicity
- Sponsor
- Other
- Results posted
- 2013-12-10
- Last update
- 24 February 2020
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Brief summary public domain (ClinicalTrials.gov)
Research Hypothesis: Ipilimumab (an antibody that blocks negative signals to T cells) administered alone or in combination with a pancreatic cancer vaccine (allogeneic pancreatic tumor cells transfected with a GM-CSF gene), has an acceptable safety profile in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma. Primary Objective: To determine the safety profile of ipilimumab alone or in combination with a pancreatic cancer vaccine in subjects with locally advanced, unresectable or metastatic pancreatic adenocarcinoma. Secondary Objectives: * To estimate overall survival (OS) which will serve as the primary efficacy signal. * To explore an association of T cell responses and immunological responses with OS in patients receiving treatment. * To estimate overall response rate (ORR), immune related best overall response rate (irBOR), progression free survival (PFS), and duration of response in patients receiving treatment. * To explore an association between immune-related adverse events (IRAEs) and ORR. * To measure tumor marker kinetics (CA 19-9) in patients receiving treatment.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Percent of Patients Experiencing an Unacceptable Toxicity [4 years]. Number, Percentage of Participants. Arm 1: Ipilimumab Alone (n=15): 6.67; Arm 2: Ipilimumab + Pancreatic Cancer Vaccine (n=15): 6.67.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [4 years]. Median, Months (95% Confidence Interval). Arm 1: Ipilimumab Alone (n=15): 3.6 (2.5 to 9.2); Arm 2: Ipilimumab + Pancreatic Cancer Vaccine (n=15): 5.7 (4.3 to 14.7).
Papers 2
- Registry-listed results paperEvaluation of ipilimumab in combination with allogeneic pancreatic tumor cells transfected with a GM-CSF gene in previo… DOI 10.1097/cji.0b013e31829fb7a2↗
- Builds on itT cell receptor repertoire features associated with survival in immunotherapy-treated pancreatic ductal adenocarcinoma. DOI 10.1172/jci.insight.122092↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.