Clinical trialPhase 1 / Phase 2Completed
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).
- Outcome
- Outcome unknown
- Phase
- Phase 1 / Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 12 December 2019
- Expected end
- 1 February 2025
- Enrollment
- 22 participants
- Sites
- 1
- Primary outcomes
- Study Drug-related Adverse Events; Tumor Immune Response (CD8+ CD137+ Tumor Infiltration)
- Sponsor
- Other
- Results posted
- 2026-05-11
- Last update
- 11 May 2026
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Brief summary public domain (ClinicalTrials.gov)
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 .
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Study Drug-related Adverse Events [Up to 18 months]. Count Of Participants, Participants. Any Study Drug-Related AE: Phase I - Dose Level 1 (n=3): 3; Phase I - Dose Level 2 (n=6): 6; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 3; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 5; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 2. Hyperthyroidism: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 1; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 0; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 0. Diarrhea: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 1; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 3; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 0. Dry mouth: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 1; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 0. Nausea: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 1; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 2; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 1. Stomach pain: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 0; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 1. Vomiting: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 1; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 0. Chills: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 1; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 1; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 1. Edema limbs: Phase I - Dose Level 1 (n=3): 0; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 2; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 1. Fatigue: Phase I - Dose Level 1 (n=3): 2; Phase I - Dose Level 2 (n=6): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 1; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 2; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 0. Fever: Phase I - Dose Level 1 (n=3): 1; Phase I - Dose Level 2 (n=6): 2; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 0;
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Tumor Immune Response (CD8+ CD137+ Tumor Infiltration) [7 months]. Count Of Participants, Participants. Phase I - Dose Level 1 (n=3): 2; Phase I - Dose Level 2 (n=5): 5; Phase II - Arm A: Nivolumab + BMS-813160 (n=3): 3; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=3): 3.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) [3 years]. Median, months (95% Confidence Interval). Phase I - Dose Level 1 (n=3): 8.2 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase I - Dose Level 2 (n=6): 12.3 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 13.4 (8.0 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 11.7 (7.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 13.7 (5.2 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Metastasis Free Survival (MFS) [3 years]. Median, months (90% Confidence Interval). Phase I - Dose Level 1 (n=3): 1.2 (0.5 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase I - Dose Level 2 (n=6): 8.4 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 3.6 (3.4 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 7.4 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 11.3 (3.6 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Local Progression Free Survival (LPFS) [3 years]. Median, months (95% Confidence Interval). Phase I - Dose Level 1 (n=3): NA (NA to NA) [Insufficient number of local progression events]; Phase I - Dose Level 2 (n=6): 8.7 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): NA (NA to NA) [Insufficient number of local progression events]; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 7.4 (5.1 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events]; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 11.3 (11.3 to NA) [Upper bound confidence interval was not estimable due to insufficient number of events].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Surgical Resectability Rate [7 months]. Count Of Participants, Participants. Phase I - Dose Level 1 (n=3): 1; Phase I - Dose Level 2 (n=6): 5; Phase II - Arm A: Nivolumab + BMS-813160 (n=5): 4; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=5): 3; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=3): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Pathological Response Rate [7 months]. Count Of Participants, Participants. complete response (grade 0): Phase I - Dose Level 1 (n=1): 1; Phase I - Dose Level 2 (n=5): 0; Phase II - Arm A: Nivolumab + BMS-813160 (n=4): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=3): 0; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=1): 0. marked response (grade 1): Phase I - Dose Level 1 (n=1): 0; Phase I - Dose Level 2 (n=5): 1; Phase II - Arm A: Nivolumab + BMS-813160 (n=4): 1; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=3): 1; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=1): 0. moderate response (grade 2): Phase I - Dose Level 1 (n=1): 0; Phase I - Dose Level 2 (n=5): 3; Phase II - Arm A: Nivolumab + BMS-813160 (n=4): 3; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=3): 2; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=1): 1. poor or no response (grade 3): Phase I - Dose Level 1 (n=1): 0; Phase I - Dose Level 2 (n=5): 1; Phase II - Arm A: Nivolumab + BMS-813160 (n=4): 0; Phase II - Arm B: Nivolumab + GVAX + BMS-813160 (n=3): 0; Phase II - Arm C: Nivolumab + BMS-813160 (Cycle 1), Nivolumab + GVAX (Cycle 2-5) (n=1): 0.