Nivolumab Combined With BMS-986253 in HCC Patients

NCT04050462 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: 18-01028
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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.

  Every 8 weeks for 1 year and every 3 months thereafter (assessed up to 5 years)

Secondary Outcomes (4)

• Time to Response (TTR)

  From treatment initiation until first sign of response (up to 5 years)

• Disease Control Rate (DOR)

  Through study completion (assessed up to 5 years)

• Progression Free Survival (PFS)

  From date of treatment until the date of first documented progression (assessed up to 5 years)

• Overall Survival (OS)

  From date of treatment until the date of death from any cause (assessed up to 5 years)

Study Arms (3)

Nivolumab Monotherapy

ACTIVE COMPARATOR

Drug: Nivolumab 240 mg IV every 2 weeks

Nivolumab/BMS-986253 combination

EXPERIMENTAL

Drug: Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks; Drug: Nivolumab 240 mg IV every 2 weeks

Nivolumab/Cabiralizumab combination

EXPERIMENTAL

Drug: Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks; Drug: Nivolumab 240 mg IV every 2 weeks

Interventions

Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks DRUG

Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy

Nivolumab/Cabiralizumab combination

Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks DRUG

Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks

Nivolumab/BMS-986253 combination

Nivolumab 240 mg IV every 2 weeks DRUG

Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy

Nivolumab Monotherapy; Nivolumab/BMS-986253 combination; Nivolumab/Cabiralizumab combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have histologically confirmed evidence of HCC, Childs-Pugh score of ≤7.
• a. Participants must be willing to provide specimen from fresh, pre- and on-treatment tumor core biopsies for histologic diagnosis and translational studies.
• Radiographically measurable disease by RECIST1.1 in at least one site.
• Deemed to not be a candidate for resection or other local-regional therapy.
• Must not be receiving treatment with other investigational agents and must not have received any other systemic therapy prior to registration.
• a. Prior radioembolization, local ablative therapies (radiofrequency, microwave or cryoablation), radiation (external beam or stereotactic), or hepatic resection permitted if completed ≥ 4 weeks prior to study enrollment and if patient has recovered with ≤ grade 1 toxicity and if untreated measurable disease is present.
• Be willing and able to provide written informed consent/assent for the trial.
• Participants must be ≥ 18 years
• Have a Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• If hepatitis B is present, participants must be on anti-viral HBV therapy.
• All women of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 24 hours prior to start of study treatment
• All women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study treatment (s) and for 5 months following discontinuation of study treatment.
• Males who are sexually active with women of childbearing potential must agree to follow instructions for method (s) of contraception for the duration of treatment with study treatment and for 7 months following discontinuation of study treatment. Additionally, male participants must not donate sperm during this period.
• Demonstrate adequate organ function as defined by the following required lab and acceptable range criteria:
• Adequate bone marrow function:

You may not qualify if:

• Women who are pregnant or breastfeeding.
• Presence of other malignancies. Participants with active second malignancy other than non-melanoma skin cancer or cervical carcinoma in situ. NOTE: Patients with history of malignancy are not considered to have a "currently active" malignancy if they have completed therapy and are now considered by their physician to be at less than 30% risk for relapse.
• Have active or history of Tuberculosis
• Participants with known HIV positive status
• Participants with known CNS metastases
• Uncontrolled ascites
• Uncontrolled encephalopathy
• Uncontrolled gastro-esophageal varicesPrior organ allograft or allogeneic bone marrow transplantation
• Participants with active, known, or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, euthyroid participants with a history of Grave's disease (participants with suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study treatment), psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration except for adrenal replacement steroid doses \> 10 mg daily prednisone equivalent in the absence of active autoimmune disease. Note: Treatment with a short course of steroids (\< 5 days) up to 7 days prior to initiating study treatment is permitted.
• Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity.
• Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
• Myocardial infarction or stroke/transient ischemic attack within the past 6 months
• Uncontrolled angina within the past 3 months
• Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Langone Health

New York, New York, 10016, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Nivolumab; cabiralizumab; HuMax-IL8

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Nina Beri, MD
• Organization: NYU Langone Health

nina.beri@nyulangone.org

212-731-5770

Study Officials

• Nina Beri, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 8, 2019
• Study Start: September 12, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: October 16, 2025
• Results First Posted: October 16, 2025

Record last verified: 2025-09

Locations

US (2)