New combo therapy shows promise in Hard-to-Treat pancreatic cancer
NCT ID NCT03767582
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of three drugs (nivolumab, BMS-813160, and GVAX) in 22 people with locally advanced pancreatic cancer who had already received chemotherapy and radiation. The goal was to see if the treatment was safe and could help the immune system better attack the tumor. While the approach aims to control the disease, it is not a cure, and ongoing management is still needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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22 people
The number who actually took part.
- Started
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Dec 2019
- Finished
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Feb 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. * 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: * Patients cannot have had any prior therapy for the locally advanced pancreatic adenocarcinoma. * Have received any anti-neoplastic biologics, vaccines or hormonal treatment, including investigational drugs, within 28 days of the first dose of study. * History of past treatment with immunotherapy agents prior to initial enrollment into this study (including, but not limited to: IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4 or anti-CCR2/5 drugs). * Have had prior organ or tissue allograft or allogeneic bone marrow transplantation, including corneal transplants. * Is currently participating or has participated in a study of an investigational agent or using an investigational device for the treatment of cancer. * Current use of immunosuppressive medications within 14 days prior to study medications. * Have received any vaccine within 14 days prior to study medications. * Receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of the first dose of study medication. * History of any autoimmune disease. Patients with thyroid disease will be allowed. * Has a history of (non-infectious) pneumonitis or current pneumonitis. * Has a pulse oximetry \< 92% on room air. * Requires the use of home oxygen. * Patients with uncontrolled intercurrent illness including, but not limited to, myocardial infarction or stroke/transient ischemic attack within the past 6 months, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * 12-lead electrocardiogram with QRS ≥ 120 msec, except right bundle branch block ; QTcF (QT corrected for heart rate using Fridericia's method) ≥ 480 msec, except right bundle branch block * Has an active infection requiring systemic therapy. * Infection with HIV or hepatitis B or C. * Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, early stage prostate cancer, or carcinoma in situ of the cervix. * Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact the absorption of study treatment. * Any gastrointestinal surgery that is likely impact upon the absorption of study treatment. * Inability to tolerate oral medication. * Unable to have blood drawn. * Have had surgery within 28 days of the first dose of study medication. * Prior use of strong/moderate CYP3A4 inhibitors or inducers within 28 days of the first dose of BMS-813160. * Prior use of Class I antiarrhythmics within 28 days of first dose of study medication. * Has ascites requiring medical management. * Presence of duodenal or gastric invasion by the tumor. * Hypersensitivity reaction to any monoclonal antibody. * Known allergy or hypersensitivity to study drugs or any of their components of the study arm that participant is enrolling. * Woman who are pregnant or breastfeeding. * Patient is unwilling or unable to follow the study schedule for any reason.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21231, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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