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NCT03523572 · ClinicalTrials.gov registry record · Phase 1

Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
86
Enrollment target

NCT03523572 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 86 participants.

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The verdict

NCT03523572, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
86 participants
Enrollment target

Study Summary

This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab. The study will be done in two parts: * Part 1 is to identify the recommended dose to use for treatment. * Part 2 is to find out how well the combination works, and how safe and tolerable it is.

Interventions

  • DRUG Nivolumab
  • DRUG Trastuzumab deruxtecan

Trial Details

FieldValue
Enrollment Target 86 participants
Start Date 2018-08-02
Est. Completion 2023-09-12
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

What the Registry Record Tells You About NCT03523572

The ClinicalTrials.gov registry entry for NCT03523572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

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

NCT03523572 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03523572 about?

NCT03523572 is a clinical study titled "Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer". This is a study of trastuzumab deruxtecan for the treatment of HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens. Participants will receive this study drug along with a cancer drug, an immune checkpoint inhibitor, anti-PD1, called nivolumab....

What is the current status of trial NCT03523572?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 86 participants. The study started on 2018-08-02. Estimated completion is 2023-09-12.

What interventions are being tested in trial NCT03523572?

The interventions under investigation include: Nivolumab (DRUG), Trastuzumab deruxtecan (DRUG).

Who is sponsoring clinical trial NCT03523572?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.