BMS-813160 / BMS - LARVOL DELTA

A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=332 | Completed | Sponsor: Bristol-Myers Squibb | Phase classification: P1b/2 ➔ P1/2

Phase classification • Colorectal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2 | N=46 | Completed | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Sep 2024 ➔ Feb 2025 | Trial primary completion date: Sep 2024 ➔ Feb 2025

Trial completion date • Trial primary completion date • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Neoadjuvant immunotherapy of hepatocellular carcinoma: A single-institution experience at Mount Sinai. (ASCO 2025) - P2 | " We identified 17 patients from NCT04123379 (nivolumab alone or in combination with BMS-813160 or BMS-986253), 41 patients from NCT03916627 (cemiplimab alone or cemiplimab plus radiation), and 8 patients who received neoadjuvant nivolumab off protocol. Neoadjuvant immunotherapy with anti-PD-1 in patients with resectable HCC appears to be feasible with a generally acceptable safety profile. Further studies are needed to identify optimal immunotherapy regimens to be used in the neoadjuvant setting as well as optimal duration, and larger cohorts are needed to validate the correlation of pathological response with recurrence and survival."

Clinical • Chronic Obstructive Pulmonary Disease • Hepatocellular Cancer • Hepatology • Immunology • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor

Neoadjuvant BMS-813160, nivolumab, gemcitabine and nab-paclitaxel for patients with pancreatic cancer. (PubMed, Clin Cancer Res) - P1/2 | "Neoadjuvant BMS-813160/nivolumab/GnP was well tolerated and appears to achieve comparable ORR and resectability to historical data, however with prolonged PFS and OS in LA-PDAC patients, warranting a larger phase II study with a more efficacious CCR2-targeted therapeutic."

Journal • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • CCR2

GCO 19-1754: Neoadjuvant Nivolumab with CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Completed ➔ Active, not recruiting | Trial completion date: Nov 2023 ➔ Dec 2025 | Trial primary completion date: Nov 2023 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2 | N=46 | Completed | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting ➔ Completed | N=30 ➔ 46 | Trial completion date: Dec 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2024 ➔ Sep 2024

Enrollment change • Metastases • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • TNFRSF9

BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: Washington University School of Medicine | Active, not recruiting ➔ Completed

Trial completion • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

GCO 19-1754: Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Icahn School of Medicine at Mount Sinai | N=36 ➔ 48 | Trial completion date: Sep 2024 ➔ Nov 2023 | Active, not recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • TNFRSF9

Targeting myeloid cells in non-small cell lung cancer and hepatocellular carcinoma: a window-of-opportunity trial of nivolumab with BMS-813160 (CCR2/5i) or BMS-986253 (anti-IL8) (ESMO-IO 2023) - P2 | "Tissue analysis with scRNA-seq and multiplex imaging is ongoing to elucidate the biologic effects of these agents. Conclusions Although CCR2/5i and anti-IL8 appear to be biologically active and exert effects on chemokine levels, they fail to significantly augment the role of ICB in the preoperative setting, contrary to preclinical evidence."

Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCR2 • CXCL8

Targeting myeloid cells in non-small cell lung cancer and hepatocellular carcinoma: a window-of-opportunity trial of nivolumab with BMS-813160 (CCR2/5 inhibitor) or BMS-986253 (anti-IL-8 antibody) (SITC 2023) - No abstract available

Late-breaking abstract • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCR2 • CXCL8

Neoadjuvant Nivolumab With CCR2/5-inhibitor or Anti-IL-8) for Non-small Cell Lung Cancer (NSCLC) or Hepatocellular Carcinoma (HCC) (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Icahn School of Medicine at Mount Sinai | Recruiting ➔ Active, not recruiting | Trial primary completion date: Oct 2024 ➔ Aug 2023

Enrollment closed • Trial primary completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of BMS-813160 in Combination With Chemotherapy or Nivolumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1b/2 | N=332 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Colorectal Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Neoadjuvant nivolumab combined with CCR2/5 inhibitor or anti-IL-8 antibody in non-small cell lung cancer and hepatocellular carcinoma (SITC 2022) - P2 | "Methods This phase IIa multi-cohort, two-stage trial was designed to assess the clinical efficacy of BMS-813160 (CCR2/5 inhibitor) and BMS-986253 (anti-IL8 antibody) in patients with resectable NSCLC and HCC. Deep immune monitoring will be performed using multiplex and single-cell analysis platforms to define the immunodynamic effects of the therapies. Trial Registration NCT04123379"

Clinical • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CCR2 • CXCL8

Nivolumab and a CCR2/CCR5 dual antagonist (BMS-813160) with or without GVAX for locally advanced pancreatic ductal adenocarcinomas: Results of phase I study. (ASCO-GI 2023) - P1/2 | " This open-label, single center two-arm phase I/II trial uses neoadjuvant/adjuvant nivolumab and BMS-813160 +/- GVAX following 8 to 16 doses of FOLFIRINOX and SBRT in patients with newly diagnosed LAPC... We determined that nivolumab 480mg IV q4 weeks, GVAX 5x108 cells intradermal q4 weeks, and BMS-813160 300mg PO BID were the RP2D for the phase 2 portion of this investigation which is ongoing. This combination appears safe and neoadjuvant use does not lead to delay in surgery. Clinical trial information: NCT03767582."

Metastases • P1 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • CCR2 • CD8 • TNFRSF9

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Mar 2023 ➔ Dec 2023 | Trial primary completion date: Mar 2023 ➔ Dec 2023

Metastases • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TNFRSF9

FRACTION-RCC: A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=182 | Completed | Sponsor: Bristol-Myers Squibb | Active, not recruiting ➔ Completed | Trial completion date: Jan 2024 ➔ Nov 2021

Combination therapy • Trial completion • Trial completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2; N=30; Recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TNFRSF9

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Initiation date: Aug 2019 ➔ Nov 2019

Clinical • Trial initiation date • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TNFRSF9

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2; N=30; Not yet recruiting; Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Clinical • New P1/2 trial • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • TNFRSF9

FRACTION-RCC: A Study to Test Combination Treatments in People With Advanced Renal Cell Carcinoma (clinicaltrials.gov) - P2 | N=155 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2023 ➔ Jan 2024

Combination therapy • Enrollment closed • Trial completion date • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

BMS-813160 With Nivolumab and Gemcitabine and Nab-paclitaxel in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (clinicaltrials.gov) - P1/2 | N=40 | Active, not recruiting | Sponsor: Washington University School of Medicine | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2025 ➔ Oct 2024 | Trial primary completion date: Oct 2024 ➔ Oct 2021

Enrollment closed • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Trial of Neoadjuvant and Adjuvant Nivolumab and BMS-813160 With or Without GVAX for Locally Advanced Pancreatic Ductal Adenocarcinomas. (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • TNFRSF9

BMS-813160: A Potent CCR2 and CCR5 Dual Antagonist Selected as a Clinical Candidate. (PubMed, ACS Med Chem Lett) - "Compound 3 was also studied in the mouse thioglycollate-induced peritonitis model, which confirmed its ability to inhibit the migration of inflammatory monocytes and macrophages. As a result of this profile, compound 3 was selected as a clinical candidate."

Clinical • Journal

A phase Ib/II study of BMS-813160, a CC chemokine receptor (CCR) 2/5 dual antagonist, in combination with chemotherapy or nivolumab in patients (pts) with advanced pancreatic or colorectal cancer (AACR 2018) - P1b/2; "In part 1, pts will receive BMS-813160 monotherapy safety lead-in for 2 weeks followed by combination with chemotherapy (5-fluorouracil + leucovorin + irinotecan [colorectal cancer] or nab-paclitaxel + gemcitabine [pancreatic cancer]) or nivolumab. Primary outcomes are safety, tolerability, objective response rate, median duration of response, and progression-free survival rate at 24 weeks. Secondary outcomes are pharmacokinetics and pharmacodynamics of BMS-813160 and immunogenicity of nivolumab."

Clinical • Combination therapy • IO biomarker • P1/2 data • PD(L)-1 Biomarker • Colorectal Cancer • Pancreatic Cancer