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NCT04108481 · ClinicalTrials.gov registry record · Phase 1

Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer

A Phase 1 study, sponsored by University of Iowa.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT04108481: Clinical Trial Phase 1 study, sponsored by University of Iowa.

NCT04108481 is a Phase 1 study that was terminated before completion, run by University of Iowa. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04108481, a Phase 1 study, was terminated before completion, sponsored by University of Iowa.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study Summary

This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal cancer (mCRC), which is mismatch repair proficient/microsatellite stable (pMMR/MSS).

Primary Outcome

MTD will be defined as the highest dose level for which at most 1 out of 6 patients experience a dose-limiting toxicity (DLT) using CTCAE version 5.0.

Interventions

  • DRUG Durvalumab
  • RADIATION Yttrium-90 RadioEmbolization

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2020-10-05
Est. Completion 2023-11-17
Phase Phase 1
University of Iowa

228 total trials

Why NCT04108481 stopped before completion

NCT04108481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

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

NCT04108481 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04108481 about?

NCT04108481 is a clinical study titled "Immunotherapy With Y90-RadioEmbolization for Metastatic Colorectal Cancer". This clinical trial will be conducted as a single-center, open-label, Phase I/2 trial to evaluate the feasibility and safety of Yttrium-90 radioembolization (Y90-RE) in combination with a fixed dose of of immunotherapy (durvalumab - 750 mg) in subjects with liver-predominant, metastatic colorectal c...

What is the current status of trial NCT04108481?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-10-05. Estimated completion is 2023-11-17.

What interventions are being tested in trial NCT04108481?

The interventions under investigation include: Durvalumab (DRUG), Yttrium-90 RadioEmbolization (RADIATION).

Who is sponsoring clinical trial NCT04108481?

This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04108481's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 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 NCT04108481, the US trial registry maintained by the National Library of Medicine. NCT04108481 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.