Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advan… (NCT03767582) | Clinical Trial Compass
CompletedPhase 1/2
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
United States46 participantsStarted 2019-12-12
Plain-language summary
The purpose of this study is to evaluate if the combination of nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with GVAX is safe in patients with locally advanced pancreatic cancer (LAPC) who have received chemotherapy and radiotherapy, and to see if this combination therapy enhances the infiltration of CD8+CD137+ cells in PDACs .
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥18 years.
* Patients with histologically- or cytologically-proven, surgically unresectable, locally advanced pancreatic adenocarcinoma.
* If the patient does not have a diagnostic biopsy that is adequate for review at our institution, the patient must agree to a research core biopsy to be performed at Johns Hopkins.
* If the patient's available imaging is not adequate for review by our institution, the patient must agree to a repeat imaging to be performed at Johns Hopkins.
* Patients cannot have had any prior therapy for the locally advanced pancreatic adenocarcinoma.
* ECOG performance status 0 or 1
* Life expectancy greater than 3 months.
* Able to swallow pills or capsules.
* Patient must have adequate organ function defined by the study-specified laboratory tests.
* Patients must be eligible to receive FOLFIRINOX-based chemotherapy.
* Patients must be willing to be treated with stereotactic body radiation therapy (SBRT) only at Johns Hopkins Hospital.
* Patients must be willing to undergo a core biopsy of the pancreatic cancer.
* Patients must be willing to undergo a biopsy of the pancreatic cancer if the patient is not deemed a surgical candidate during the pre-surgical evaluation.
* Must use acceptable form of birth control while on study.
* Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
* Have had non-FOLFIRINOX-based chemotherapy for the pancreatic cancer.
* Have received any anti-n…
What they're measuring
1
Number of Participants experiencing study drug-related toxicities
Timeframe: 3 years
2
Percentage of participants treated with immunotherapy who achieve an immune response
Timeframe: 3 years
Trial details
NCT IDNCT03767582
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins