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NCT02754856 · ClinicalTrials.gov registry record · Phase 1

Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT02754856: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT02754856 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02754856, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Primary Outcome

Post-operative toxicity graded by the Clavien-Dindo classification. The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V). Grade I complications are usually mild but Grade II and higher complications are more significant.

Interventions

  • BIOLOGICAL Durvalumab
  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Tremelimumab

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2016-08-29
Est. Completion 2023-01-30
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02754856 record still lists

NCT02754856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 4 interventions - of which Durvalumab is the first listed.

NCT02754856 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02754856 about?

NCT02754856 is a clinical study titled "Tremelimumab and Durvalumab in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery". This phase I trial studies the side effects and how well tremelimumab and durvalumab work in treating patients with colorectal cancer that has spread to the liver and can be removed by surgery. Immunotherapy with monoclonal antibodies, such as tremelimumab and durvalumab, may help the body's immune ...

What is the current status of trial NCT02754856?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-08-29. Estimated completion is 2023-01-30.

What interventions are being tested in trial NCT02754856?

The interventions under investigation include: Durvalumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Tremelimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02754856?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02754856's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 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 NCT02754856, the US trial registry maintained by the National Library of Medicine. NCT02754856 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.