P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Dec 2025 --> Aug 2026 | Trial primary completion date: Dec 2024 --> Aug 2025

17 days ago

Trial completion date • Trial primary completion date • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)

CD8 expression

Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)

2ms

Spark2: Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (clinicaltrials.gov)

P2, N=24, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Aug 2024 --> Apr 2025

2 months ago

Trial primary completion date • Combination therapy • Surgery

Opdivo (nivolumab) • BMS-986253

6ms

BMS-986253 in Myelodysplastic Syndromes (clinicaltrials.gov)

P1/2, N=2, Terminated, National Cancer Institute (NCI) | N=200 --> 2 | Trial completion date: Jul 2025 --> Jul 2023 | Active, not recruiting --> Terminated; Company closed the trial.

6 months ago

Enrollment change • Trial completion date • Trial termination

CXCL8 (Chemokine (C-X-C motif) ligand 8)

decitabine • BMS-986253

7ms

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors (clinicaltrials.gov)

P1, N=50, Recruiting, Jason J. Luke, MD | Suspended --> Recruiting

7 months ago

Enrollment open • Metastases

Opdivo (nivolumab) • BMS-986253

7ms

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, Icahn School of Medicine at Mount Sinai | N=36 --> 48 | Trial completion date: Sep 2024 --> Nov 2023 | Active, not recruiting --> Completed

7 months ago

Trial completion • Enrollment change • Trial completion date

Opdivo (nivolumab) • BMS-813160 • BMS-986253

7ms

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors (clinicaltrials.gov)

P1, N=50, Suspended, Jason J. Luke, MD | Trial completion date: Dec 2026 --> May 2027 | Recruiting --> Suspended | Trial primary completion date: Dec 2025 --> May 2024

7 months ago

Trial completion date • Trial suspension • Trial primary completion date • Metastases

Opdivo (nivolumab) • BMS-986253

9ms

Spark2: Neoadjuvant Targeting of Myeloid Cell Populations in Combination With Nivolumab in Head & Neck Ca (clinicaltrials.gov)

P2, N=24, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial primary completion date: Apr 2024 --> Aug 2024

9 months ago

Trial primary completion date • Combination therapy • Surgery

Opdivo (nivolumab) • BMS-986253

10ms

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers (clinicaltrials.gov)

P1/2, N=372, Active, not recruiting, Bristol-Myers Squibb | Recruiting --> Active, not recruiting

10 months ago

Enrollment closed

Opdivo (nivolumab) • Yervoy (ipilimumab) • BMS-986253

1year

Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8) (clinicaltrials.gov)

P1/2, N=60, Active, not recruiting, Mark Stein | Phase classification: P1b/2 --> P1/2 | Trial completion date: Dec 2023 --> Jan 2025 | Trial primary completion date: Oct 2023 --> May 2024

1 year ago

Phase classification • Trial completion date • Trial primary completion date • Combination therapy

Opdivo (nivolumab) • Firmagon (degarelix) • BMS-986253

1year

BMS-986253 in Myelodysplastic Syndromes (clinicaltrials.gov)

P1/2, N=200, Active, not recruiting, National Cancer Institute (NCI) | Recruiting --> Active, not recruiting | Trial completion date: Jan 2025 --> Jul 2025 | Trial primary completion date: Jan 2025 --> Jul 2023

1 year ago

Enrollment closed • Trial completion date • Trial primary completion date

Inqovi (decitabine/cedazuridine) • BMS-986253

1year

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

1 year ago

Late-breaking abstract

CXCL8 (Chemokine (C-X-C motif) ligand 8) • CCR2 (C-C Motif Chemokine Receptor 2)

Opdivo (nivolumab) • BMS-813160 • BMS-986253

over1year

Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors (clinicaltrials.gov)

P1, N=50, Recruiting, Jason J. Luke, MD | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2023 --> Dec 2025

over 1 year ago

Trial completion date • Trial primary completion date • Metastases

Opdivo (nivolumab) • BMS-986253

over1year

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)

P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2024 --> Dec 2025 | Trial primary completion date: Jun 2023 --> Dec 2024

over 1 year ago

Trial completion date • Trial primary completion date • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)

Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)

almost2years

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers (clinicaltrials.gov)

P1/2, N=372, Recruiting, Bristol-Myers Squibb | Trial completion date: Jun 2024 --> Nov 2025 | Trial primary completion date: Feb 2023 --> Apr 2024

almost 2 years ago

Trial completion date • Trial primary completion date • Combination therapy • Pan tumor • Metastases

CXCL8 (Chemokine (C-X-C motif) ligand 8)

Opdivo (nivolumab) • Yervoy (ipilimumab) • BMS-986253

2years

Anti-IL-8 BMS-986253 + nivolumab (NIVO) ± ipilimumab (IPI) in patients (pts) with advanced cancer: update of initial phase 1 results (ESMO-IO 2022)

Preliminary and durable antitumor activity was observed across a range of doses/regimens. These findings support further evaluation of BMS-986253 in pts with melanoma following anti–PD-(L)1 therapy in the phase 2 part of this study.

2 years ago

Clinical • P1 data

CXCL8 (Chemokine (C-X-C motif) ligand 8) • CXCR1 (Chemokine (C-X-C motif) receptor 1) • CXCR2 (Chemokine (C-X-C motif) receptor 2)

CXCL8 elevation

Opdivo (nivolumab) • Yervoy (ipilimumab) • BMS-986253

2years

Neoadjuvant nivolumab combined with CCR2/5 inhibitor or anti-IL-8 antibody in non-small cell lung cancer and hepatocellular carcinoma (SITC 2022)

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

2 years ago

Clinical

CXCL8 (Chemokine (C-X-C motif) ligand 8) • CCR2 (C-C Motif Chemokine Receptor 2)

Opdivo (nivolumab) • BMS-813160 • BMS-986253

over2years

Stereotactic Body Radiation Therapy Plus Anti-PD1/IL8 Therapy for Advanced Solid Tumors (ASTRO 2022)

The present study aims to evaluate safety and preliminary efficacy of combining BMS-986253 with nivolumab and SBRT in patients with advanced solid tumors, chiefly melanoma (MEL) and renal cell carcinoma (RCC). Blocking IL8 in conjunction with anti-PD1 therapy and SBRT is a rational, biomarker-driven approach that may overcome resistance and broaden immunotherapy benefit in patients for whom anti-PD1 therapy is inadequate. This trial is registered at ClinicalTrials.gov, NCT04572451.

over 2 years ago

PD(L)-1 Biomarker • IO biomarker

CXCL8 (Chemokine (C-X-C motif) ligand 8)

CXCL8 elevation • CXCL8 expression

Opdivo (nivolumab) • BMS-986253

almost3years

A randomized, double-blind phase 2 evaluation of the anti-IL-8 monoclonal antibody BMS-986253 + nivolumab + ipilimumab vs nivolumab + ipilimumab in patients with advanced melanoma that progressed on/after anti-PD-(L)1 therapy (AACR 2022)

Secondary objectives include PFS by BICR in all randomized patients, overall response rates by BICR per RECIST v1.1, overall survival, safety, pharmacokinetic profile, immunogenicity of BMS-986253, and associations of baseline factors with response. Recruitment will continue until ≈170 patients are enrolled.

almost 3 years ago

Clinical • P2 data • PD(L)-1 Biomarker • IO biomarker

BRAF (B-raf proto-oncogene) • CXCL8 (Chemokine (C-X-C motif) ligand 8)

BRAF V600E • BRAF V600 • BRAF wild-type • CXCL8 elevation • BRAF V600 wild-type

Opdivo (nivolumab) • Yervoy (ipilimumab) • BMS-986253

almost3years

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)

P2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Phase classification: P1/2 --> P2

almost 3 years ago

Clinical • Phase classification • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)

Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)

3years

ROLE OF PORTAL BLOOD CSF1R/IL-8 SIGNALING IN PANCREATIC CANCER CIRCULATING TUMOR CELL SURVIVAL (APCM 2021)

To test the importance of myeloid attraction and signaling to CTC survival in the portal blood, humanized monoclonal blocking antibodies to CSF1R (BMS-986227, Cabralizumab), IL-8 (BMS-986253), and mouse monoclonal antibodies to IL-34 (1D12, Abcam) were used to inhibit CTC/M-FB signaling pathways. Blocking IL-8 signaling from CTC allowed myeloid cells to produce their own IL-8 and avoid being drawn to CTC and their CSF1/IL-34/CSF2 influence on myeloid differentiation. Without myeloid cell attraction and differentiation, clusters don’t form, leaving CTC unaided by M-FB, and myeloid cells differentiating away from immunosuppressive, pro-tumor phenotypes. Such treatments could lead to enhanced anti-tumor myeloid cell responses and suppression of CTC survival.

3 years ago

Circulating Tumor Cells

CXCL8 (Chemokine (C-X-C motif) ligand 8) • CD44 (CD44 Molecule) • PTPRC (Protein Tyrosine Phosphatase Receptor Type C) • CD14 (CD14 Molecule) • CSF1R (Colony stimulating factor 1 receptor) • CXCR2 (Chemokine (C-X-C motif) receptor 2) • ENG (Endoglin) • BSG (Basigin (Ok Blood Group))

CXCL8 expression

cabiralizumab (BMS-986227) • BMS-986253

3years

Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19 (clinicaltrials.gov)

P2, N=43, Terminated, Matthew Dallos | N=138 --> 43 | Trial completion date: Sep 2022 --> Mar 2021 | Recruiting --> Terminated | Trial primary completion date: Sep 2021 --> Mar 2021; Interim analysis indicated that futility boundary was reached.

3 years ago

Clinical • Enrollment change • Trial completion date • Trial termination • Trial primary completion date

CXCL8 (Chemokine (C-X-C motif) ligand 8)

BMS-986253

3years

Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas (clinicaltrials.gov)

P1/2, N=76, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Feb 2023 --> Jun 2024 | Trial primary completion date: Jun 2022 --> Jun 2023

3 years ago

Clinical • Trial completion date • Trial primary completion date • IO biomarker

CD8 (cluster of differentiation 8) • PD-1 (Programmed cell death 1) • TNFRSF9 (TNF Receptor Superfamily Member 9) • GZMB (Granzyme B) • IL17A (Interleukin 17A)

Opdivo (nivolumab) • cyclophosphamide • BMS-986253 • GVAX Pancreas (allogeneic GM-CSF-secreting tumor cells) • urelumab (BMS-663513)

over3years

[VIRTUAL] Phase I study investigating the safety of stereotactic body radiotherapy (SBRT) with anti-PD-1 and anti-IL-8 for the treatment of multiple metastases in advanced solid tumors. (ASCO 2021)

The combination of BMS-986253 and nivolumab was safe in patients with advanced solid tumors . We will include 20 patients with MEL and RCC and compare against a historical benchmark of 20% ORR as sufficient signal of activity for further study . ORR will be assessed for association with serum IL-8 levels and radiation-induced changes in peripheral blood T cell populations.

over 3 years ago

Clinical • P1 data

CXCL8 (Chemokine (C-X-C motif) ligand 8)

CXCL8 elevation

Opdivo (nivolumab) • BMS-986253

almost4years

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers (clinicaltrials.gov)

P1/2, N=372, Recruiting, Bristol-Myers Squibb | Active, not recruiting --> Recruiting | Trial completion date: Nov 2023 --> Jun 2024 | Trial primary completion date: Nov 2023 --> Feb 2023

almost 4 years ago

Enrollment open • Trial completion date • Trial primary completion date • Combination therapy • Pan tumor

CXCL8 (Chemokine (C-X-C motif) ligand 8)

Opdivo (nivolumab) • Yervoy (ipilimumab) • BMS-986253

over4years

Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19 (clinicaltrials.gov)

P2, N=138, Recruiting, Matthew Dallos | Not yet recruiting --> Recruiting

over 4 years ago

Clinical • Enrollment open

CXCL8 (Chemokine (C-X-C motif) ligand 8)

BMS-986253

over4years

Anti-Interleukin-8 (Anti-IL-8) for Patients With COVID-19 (clinicaltrials.gov)

P2, N=138, Not yet recruiting, Matthew Dallos

over 4 years ago

Clinical • New P2 trial

CXCL8 (Chemokine (C-X-C motif) ligand 8)

BMS-986253