Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Res… (NCT03153410) | Clinical Trial Compass
CompletedEarly Phase 1
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
United States11 participantsStarted 2018-09-27
Plain-language summary
The purpose of this study is to evaluate whether combining cyclophosphamide (CY), pembrolizumab, GVAX and IMC-CS4 is effective and safe in patients with borderline resectable pancreatic cancer.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have histologically or cytologically proven adenocarcinoma of the pancreas.
* Patient's acceptance to have a core biopsy.
* Presence of at least one measurable lesion.
* Must not have metastatic disease.
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See Section 10.1.2 for the evaluation of measurable disease.
* Must have received last dose of stereotactic body radiotherapy no longer than 28 days prior to enrollment.
* Must have received last dose of chemotherapy at least 14 days or longer prior to entry into the study.
* Age \>18 years.
* ECOG performance status 0-1.
* Patient's blood, kidney and liver function must within normal limits
* Must use an acceptable form of birth control while on study.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Currently is participating or has participated in a study using any investigational therapy within the past 28 days or is currently using an investigational device.
* Major surgery 28 days prior to study entry excluding minor procedures (dental work, skin biopsy, etc.), celiac plexus block, and biliary stent placement.
* Used any systemic steroids, immunosuppressant medications and anti-neoplastic treatment in the past 14 days.
* Prior treatment with immunoth…
What they're measuring
1
Number of Patients With a Treatment-related Immunologic Effect
Timeframe: 8 weeks
2
Safety of the Combination of GVAX Pancreas Vaccine (With CY), Pembrolizumab, and a Macrophage Targeting Agent (CSF1R Inhibitor IMC-CS4) in Patients With Resectable or Borderline Resectable Pancreatic Cancer (BRPC) Prior to and Following Surgery
Timeframe: 25 months
Trial details
NCT IDNCT03153410
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins