Who is sponsoring NCT04050462?

NCT04050462 is sponsored by NYU Langone Health.

What drugs are being tested in NCT04050462?

Interventions in NCT04050462: Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks, Nivolumab 240 mg IV every 2 weeks.

What condition does NCT04050462 study?

NCT04050462 studies Hepatocellular Carcinoma.

Is NCT04050462 still recruiting?

NCT04050462 is currently terminated. Last updated 16 October 2025.

Are results published for NCT04050462?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-10-16 · How we verify

NCT04050462

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Nivolumab Combined With BMS-986253 in HCC Patients

Terminated Phase 2 Results posted Last updated 16 October 2025

What this trial tests

Phase 2 trial testing Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks in Hepatocellular Carcinoma in 13 participants. Terminated before completion.

Timeline

12 September 2019

Primary endpoint
31 January 2025

31 January 2025

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	12 September 2019
Primary completion	31 January 2025
Estimated completion	31 January 2025
Sites	2 locations across United States

Drugs / interventions tested

Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks — full drug profile →
Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks — full drug profile →
Nivolumab 240 mg IV every 2 weeks — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Objective Response Rate (ORR) Primary · Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)

ORR is measured as the percentage of people in a study or treatment group who have a partial response or complete response to the treatment. ORR will be determined based upon RECIST v. 1.1 criteria. Per RECIST v. 1.1 criteria, a Complete Response (CR) is the disappearance of all target lesions, and a Partial Response (PR) is at least a 30% decrease in the sum of the longest diameters (LD) of the target lesions, compared to the baseline.

Group	Value	95% CI
Nivolumab Monotherapy	20
Nivolumab/BMS-986253 Combination	28.57

Time to Response (TTR) Secondary · From treatment initiation until first sign of response (up to 5 years)

TTR is the amount of time it takes for a tumor to show a measurable decrease in size or other signs of response after treatment begins

Group	Value	95% CI
Nivolumab Monotherapy	126	126 – 126
Nivolumab/BMS-986253 Combination	116	115 – 117

Disease Control Rate (DOR) Secondary · Through study completion (assessed up to 5 years)

DOR is the percentage of patients who experience either a complete response (CR), a partial response (PR), or stable disease (SD) to a treatment

Group	Value	95% CI
Nivolumab Monotherapy	80
Nivolumab/BMS-986253 Combination	57.14

Progression Free Survival (PFS) Secondary · From date of treatment until the date of first documented progression (assessed up to 5 years)

PFS is measured as the time from the date of enrollment to disease progression per RECIST v. 1.1 criteria.

Group	Value	95% CI
Nivolumab Monotherapy	191	57 – 1995
Nivolumab/BMS-986253 Combination	171	52 – 985

Overall Survival (OS) Secondary · From date of treatment until the date of death from any cause (assessed up to 5 years)

OS is the time from treatment start to death of participants.

Group	Value	95% CI
Nivolumab Monotherapy	465	145 – 1995
Nivolumab/BMS-986253 Combination	409	127 – 1422

Adverse events — posted to ClinicalTrials.gov

Time frame: AEs and SAEs are assessed from the time of consent until 100 days following the last administration of study treatment (through study completion, up to 64 months). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Nivolumab Monotherapy

Serious: 1/6 (17%)

Deaths: 0/6

Nivolumab/BMS-986253 Combination

Serious: 3/7 (43%)

Deaths: 2/7

Nivolumab/Cabiralizumab Combination

Serious: 0

Deaths: 0

Serious adverse events (12 terms)

Reaction	System	Nivolumab Monotherapy	Nivolumab/BMS-986253 Combi…	Nivolumab/Cabiralizumab Co…
Anemia	Blood and lymphatic system disorders	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Encephalopathy	Nervous system disorders	—	—	—
Fever	General disorders	—	—	—
Gastrointestinal Disorders	Gastrointestinal disorders	—	—	—
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Peripheral Ischemia	Vascular disorders	—	—	—
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—
Skin Infection	Skin and subcutaneous tissue disorders	—	—	—
Thromboembolic Event	Vascular disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—

Other adverse events (90 terms — click to expand)

Reaction	System	Nivolumab Monotherapy	Nivolumab/BMS-986253 Combi…	Nivolumab/Cabiralizumab Co…
Hyponatremia	Metabolism and nutrition disorders	—	—	—
Alkaline Phosphatase Increased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Lymphocyte Count Decreased	Investigations	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Hypoalbuminemia	Metabolism and nutrition disorders	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—
Anorexia	Metabolism and nutrition disorders	—	—	—
Blood Bilirubin Increased	Investigations	—	—	—
Edema Limbs	Musculoskeletal and connective tissue disorders	—	—	—
Fall	Injury, poisoning and procedural complications	—	—	—
Fatigue	General disorders	—	—	—
Headache	Vascular disorders	—	—	—
Hyperkalemia	Metabolism and nutrition disorders	—	—	—
Hypokalemia	Metabolism and nutrition disorders	—	—	—
INR Increased	Investigations	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Pain	General disorders	—	—	—
Pain In Extremity	Musculoskeletal and connective tissue disorders	—	—	—
Platelet Count Decreased	Investigations	—	—	—
Rash Acneiform	Skin and subcutaneous tissue disorders	—	—	—
Rash Maculo	Skin and subcutaneous tissue disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Ascites	Gastrointestinal disorders	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—
Blood And Lymphatic System Disorders	Blood and lymphatic system disorders	—	—	—
Chest Pain	Cardiac disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Creatinine Increased	Investigations	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—
Fever	General disorders	—	—	—
Fracture	Injury, poisoning and procedural complications	—	—	—
General Disorders And Administration Site Conditions	General disorders	—	—	—
Hyperglycemia	Metabolism and nutrition disorders	—	—	—
Hypocalcemia	Metabolism and nutrition disorders	—	—	—

Most-reported serious reactions: Anemia, Aspartate Aminotransferase Increased, Dyspnea, Encephalopathy, Fever, Gastrointestinal Disorders, Hyponatremia, Peripheral Ischemia.

Data from ClinicalTrials.gov NCT04050462 adverse events section.

Sponsor's own description

A phase II clinical trial is utilized to examine whether BMS-986253 (25 subjects) or Cabiralizumab (25 subjects) when combined with Nivolumab offers improved radiographic objective response rates (ORR) over Nivolumab monotherapy (25 subjects) in advanced HCC patients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting tumor-associated macrophages to synergize tumor immunotherapy.
Xiang X, Wang J, Lu D, Xu X. · · 2021 · cited 712× · PMID 33619259 · DOI 10.1038/s41392-021-00484-9
Interleukins in cancer: from biology to therapy.
Briukhovetska D, Dörr J, Endres S, Libby P, et al · · 2021 · cited 587× · PMID 34083781 · DOI 10.1038/s41568-021-00363-z
The chemokines CXCL8 and CXCL12: molecular and functional properties, role in disease and efforts towards pharmacological intervention.
Cambier S, Gouwy M, Proost P. · · 2023 · cited 387× · PMID 36725964 · DOI 10.1038/s41423-023-00974-6
The Evasion Mechanisms of Cancer Immunity and Drug Intervention in the Tumor Microenvironment.
Kim SK, Cho SW. · · 2022 · cited 300× · PMID 35685630 · DOI 10.3389/fphar.2022.868695
Tumor-associated macrophages in liver cancer: From mechanisms to therapy.
Cheng K, Cai N, Zhu J, Yang X, et al · · 2022 · cited 289× · PMID 36069342 · DOI 10.1002/cac2.12345
Interleukin-8: A chemokine at the intersection of cancer plasticity, angiogenesis, and immune suppression.
Fousek K, Horn LA, Palena C. · · 2021 · cited 278× · PMID 32980444 · DOI 10.1016/j.pharmthera.2020.107692
Macrophage Polarity and Disease Control.
Kadomoto S, Izumi K, Mizokami A. · · 2021 · cited 245× · PMID 35008577 · DOI 10.3390/ijms23010144
Tumor cell plasticity in targeted therapy-induced resistance: mechanisms and new strategies.
Shi ZD, Pang K, Wu ZX, Dong Y, et al · · 2023 · cited 168× · PMID 36906600 · DOI 10.1038/s41392-023-01383-x

Verify or expand the search:

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting

Other NYU Langone Health trials

Trials by the same sponsor.

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NCT06637852 — Sexual and Urinary Function Improvement for Cancer Survivors · NA · not yet recruiting
NCT06236087 — Overdose Prevention Centers and Behavioral Health · not yet recruiting
NCT06462027 — Packed Red Blood Cell Transfusion During Cardiac Arrest · Phase 1 · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04050462 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NYU Langone Health
Last refreshed: 16 October 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04050462.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing