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NCT03666273 · ClinicalTrials.gov registry record · Phase 1

Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
60
Enrollment target

NCT03666273 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 60 participants.

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The verdict

NCT03666273, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
60 participants
Enrollment target

Study Summary

This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to participants and to obtain a preliminary assessment of the tumor response efficacy in the recurrent or metastatic Head and Neck Cancer.

Interventions

  • DRUG Bapotulimab (BAY1905254)
  • DRUG Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2018-09-12
Est. Completion 2024-05-15
Phase Phase 1

Sponsor

Bayer

591 total trials

What the Registry Record Tells You About NCT03666273

The ClinicalTrials.gov registry entry for NCT03666273 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Bapotulimab (BAY1905254) is the first listed.

NCT03666273 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03666273 about?

NCT03666273 is a clinical study titled "Phase 1 Study of BAY1905254 - An Early Clinical Research Study to Evaluate a New Drug Called Bapotulimab (BAY1905254) in the Expansion Cohort in Combination With Pembrolizumab in Head and Neck Cancer That Has Returned or is Discovered to be Metastatic and is Expressing PDL1.". This study is being done to learn more about a new drug called Bapotulimab given in combination with Pembrolizumab. The purpose of this study is to learn if this new combination of drugs is safe for the participants, how it affects the body and to try to find the best dose of the new drug to give to...

What is the current status of trial NCT03666273?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2018-09-12. Estimated completion is 2024-05-15.

What interventions are being tested in trial NCT03666273?

The interventions under investigation include: Bapotulimab (BAY1905254) (DRUG), Bapotulimab (BAY1905254) + Pembrolizumab (KEYTRUDA®) (DRUG).

Who is sponsoring clinical trial NCT03666273?

This trial is sponsored by Bayer, which has 591 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.