Clinical trial · Interventional
Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas.
A Phase I/II Trial of Combination Immunotherapy With Nivolumab and a CCR2/CCR5 Dual Antagonist (BMS-813160) With or Without GVAX Following Chemotherapy and Radiotherapy for Locally Advanced Pancreatic Ductal Adenocarcinomas (PDACs).
- 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)
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 .
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) | Pancreatic Ductal Adenocarcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCR2/CCR5 dual antagonist | Drug | — | UNRESOLVED |
| GVAX | Drug | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
| Stereotactic Body Radiation (SBRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I - GVAX/Nivolumab/CCR2/CCR5 dual antagonist
- interventionNames
- Radiation: Stereotactic Body Radiation (SBRT)
- Drug: Nivolumab
- Drug: CCR2/CCR5 dual antagonist
- Drug: GVAX
- type
- EXPERIMENTAL
- label
- Phase II - Arm A: Nivolumab/CCR2/CCR5 dual antagonist
- interventionNames
- Radiation: Stereotactic Body Radiation (SBRT)
- Drug: Nivolumab
- Drug: CCR2/CCR5 dual antagonist
- type
- EXPERIMENTAL
- label
- Phase II - Arm B: Nivolumab/GVAX/CCR2/CCR5 dual antagonist
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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