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NCT04050462 · ClinicalTrials.gov registry record · Phase 2

Nivolumab Combined With BMS-986253 in HCC Patients

A Phase 2 study, sponsored by NYU Langone Health.

Terminated
Registry status
Phase 2
Development phase
13
Enrollment target

NCT04050462: Clinical Trial Phase 2 study, sponsored by NYU Langone Health.

NCT04050462 is a Phase 2 study that was terminated before completion, run by NYU Langone Health. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04050462, a Phase 2 study, was terminated before completion, sponsored by NYU Langone Health.

TERMINATED
Registry status
Phase 2
Development phase
13 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks
  • DRUG Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks
  • DRUG Nivolumab 240 mg IV every 2 weeks

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2019-09-12
Est. Completion 2025-01-31
Phase Phase 2
NYU Langone Health

1,164 total trials

Why NCT04050462 stopped before completion

NCT04050462 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 3 interventions - of which Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks is the first listed.

NCT04050462 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04050462 about?

NCT04050462 is a clinical study titled "Nivolumab Combined With BMS-986253 in HCC Patients". 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.

What is the current status of trial NCT04050462?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2019-09-12. Estimated completion is 2025-01-31.

What interventions are being tested in trial NCT04050462?

The interventions under investigation include: Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks (DRUG), Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks (DRUG), Nivolumab 240 mg IV every 2 weeks (DRUG).

Who is sponsoring clinical trial NCT04050462?

This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04050462's enrollment target sits among peer trials

13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04050462, the US trial registry maintained by the National Library of Medicine. NCT04050462 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.