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NCT03084471 · ClinicalTrials.gov registry record · Phase 3

An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.

A Phase 3 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
867
Enrollment target

NCT03084471: Completed Phase 3 study, sponsored by AstraZeneca.

NCT03084471 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 867 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03084471, a Phase 3 study, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
867 participants
Enrollment target

Study Summary

To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

Primary Outcome

Incidence, severity, nature, seriousness, intervention/treatment, outcome, and causality of AESIs were assessed. AESIs included events with a potential inflammatory or immune-mediated mechanism that required interventions such as steroids, immunosuppressants, and/or hormone replacement therapy.

Interventions

  • BIOLOGICAL MEDI4736 (Durvalumab)
  • BIOLOGICAL MEDI4736 (Durvalumab) + Tremelimumab

Trial Details

FieldValue
Enrollment Target 867 participants
Start Date 2017-06-05
Est. Completion 2022-12-16
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT03084471 record still lists

NCT03084471 is an interventional study that assigns participants to a tested intervention. The registered 867 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (12% higher).

The record links to 0 conditions, and to 2 interventions - of which MEDI4736 (Durvalumab) is the first listed.

NCT03084471 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03084471 about?

NCT03084471 is a clinical study titled "An Open-Label, Multi-Centre, Study to Assess the Safety of Fixed-Dose Durvalumab + Tremelimumab Combination Therapy or Durvalumab Monotherapy in Advanced Solid Malignancies.". To evaluate the safety, tolerability, and anti-tumor activity of the combination of durvalumab + tremelimumab or durvalumab alone in different solid tumors.

What is the current status of trial NCT03084471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 867 participants. The study started on 2017-06-05. Estimated completion is 2022-12-16.

What interventions are being tested in trial NCT03084471?

The interventions under investigation include: MEDI4736 (Durvalumab) (BIOLOGICAL), MEDI4736 (Durvalumab) + Tremelimumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03084471?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03084471's enrollment target sits among peer trials

867 376th of 2000 higher than 1,625 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT03084471, the US trial registry maintained by the National Library of Medicine. NCT03084471 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.