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NCT05199285 · ClinicalTrials.gov registry record · Phase 2

A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab

A Phase 2 study, sponsored by Academic and Community Cancer Research United.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT05199285: Clinical Trial Phase 2 study, sponsored by Academic and Community Cancer Research United.

NCT05199285 is a Phase 2 study that was terminated before completion, run by Academic and Community Cancer Research United. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05199285, a Phase 2 study, was terminated before completion, sponsored by Academic and Community Cancer Research United.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Nivolumab and ipilimumab may be effective in killing tumor cells in patients with liver cancer.

Primary Outcome

A confirmed response is defined to be either a complete response (CR) or partial response (PR) noted as the objective status on 2 consecutive evaluations at least 4 weeks apart. Disease status will be assessed using response evaluation criteria in solid tumors (RECIST) version (v.) 1.1 criteria. Overall Response Rate (ORR) is defined as the proportion of evaluable patients who achieve confirmed response (CR or PR) while on treatment. The final ORR point estimate and corresponding 95% confidence

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-01-19
Est. Completion 2025-09-04
Phase Phase 2

Why NCT05199285 stopped before completion

NCT05199285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.

NCT05199285 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05199285 about?

NCT05199285 is a clinical study titled "A Phase II Study of Nivolumab + Ipilimumab in Advanced HCC Patients Who Have Progressed on First Line Atezolizumab + Bevacizumab". This phase II trial tests whether nivolumab and ipilimumab works to shrink tumors in patients with liver cancer that has spread to nearby tissue or lymph nodes (locally advanced), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Immunotherapy with ...

What is the current status of trial NCT05199285?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2023-01-19. Estimated completion is 2025-09-04.

What interventions are being tested in trial NCT05199285?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT05199285?

This trial is sponsored by Academic and Community Cancer Research United, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05199285's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 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 NCT05199285, the US trial registry maintained by the National Library of Medicine. NCT05199285 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.