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NCT03511222 · ClinicalTrials.gov registry record · Phase 1

Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors

A Phase 1 study, sponsored by Washington University School of Medicine.

Terminated
Registry status
Phase 1
Development phase
16
Enrollment target

NCT03511222: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.

NCT03511222 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03511222, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in gastrointestinal (GI) cancers.

Primary Outcome

-The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 patients of a cohort (of 2 to 6 patients) experience dose-limiting toxicity during the first cycle. Dose escalations will proceed for both nivolumab and pembrolizumab until the MTD or highest dose level (level 2), which is defined as RP2D.

Interventions

  • DRUG Pembrolizumab
  • DRUG Nivolumab
  • DRUG Vorolanib

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2018-09-11
Est. Completion 2020-05-28
Phase Phase 1

Why NCT03511222 stopped before completion

NCT03511222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT03511222 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03511222 about?

NCT03511222 is a clinical study titled "Vorolanib (X-82) Combined With Checkpoint Inhibitors in Patients With Solid Tumors". The investigators hypothesize that vorolanib in combination with checkpoint inhibitors (pembrolizumab for gastric/gastroesophageal (GE) junction cancers and nivolumab for hepatocellular carcinoma (HCC)) may improve immunotherapy efficacy by overcoming treatment resistance of checkpoint inhibitors in...

What is the current status of trial NCT03511222?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-09-11. Estimated completion is 2020-05-28.

What interventions are being tested in trial NCT03511222?

The interventions under investigation include: Pembrolizumab (DRUG), Nivolumab (DRUG), Vorolanib (DRUG).

Who is sponsoring clinical trial NCT03511222?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03511222's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT03511222, the US trial registry maintained by the National Library of Medicine. NCT03511222 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.