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NCT03735628 · ClinicalTrials.gov registry record · Phase 1

An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT03735628: Completed Phase 1 study, sponsored by Bayer.

NCT03735628 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03735628, a Phase 1 study, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will then be used in Phase 2 (dose expansion) of the study.

Interventions

  • DRUG Nivolumab
  • DRUG Copanlisib

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2018-10-17
Est. Completion 2022-10-13
Phase Phase 1
Bayer

591 total trials

What the finished NCT03735628 record still lists

NCT03735628 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

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

NCT03735628 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03735628 about?

NCT03735628 is a clinical study titled "An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors". The purpose of the dose escalation part of this study is to determine the feasibility of using the combination of copanlisib and nivolumab in subjects with advanced solid tumors, and to determine the maximum tolerated dose of copanlisib in combination with nivolumab. The maximum tolerated dose will ...

What is the current status of trial NCT03735628?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2018-10-17. Estimated completion is 2022-10-13.

What interventions are being tested in trial NCT03735628?

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

Who is sponsoring clinical trial NCT03735628?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03735628's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 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 NCT03735628, the US trial registry maintained by the National Library of Medicine. NCT03735628 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.