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NCT02011945 · ClinicalTrials.gov registry record · Phase 1

A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia

A Phase 1 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
35
Enrollment target

NCT02011945: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.

NCT02011945 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 35 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02011945, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
35 participants
Enrollment target

Study Summary

The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.

Primary Outcome

DLT will be determined based on the incidence and intensity of drug related adverse events (AEs). The following drug-related AEs (whether related to one or both agents) occurring during the first 6 weeks of combined treatment with both dasatinib plus nivolumab (ie, Weeks 3 to 8, inclusive) would be considered DLTs: * Grade 4 hematologic AE lasting \> 7 days despite appropriate medical intervention, except as noted below; * Grade 3 or Grade 4 nonhematologic AE irrespective of duration; * Grade 2

Interventions

  • DRUG Nivolumab
  • DRUG Dasatinib

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2014-02-07
Est. Completion 2018-12-26
Phase Phase 1
Bristol-Myers Squibb

1,025 total trials

What the finished NCT02011945 record still lists

NCT02011945 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% lower).

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

NCT02011945 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02011945 about?

NCT02011945 is a clinical study titled "A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia". The purpose of this study is to find a dose of Nivolumab that can be safely added to Dasatinib in patients with Chronic Myeloid Leukemia.

What is the current status of trial NCT02011945?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2014-02-07. Estimated completion is 2018-12-26.

What interventions are being tested in trial NCT02011945?

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

Who is sponsoring clinical trial NCT02011945?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02011945's enrollment target sits among peer trials

35 1258th of 2000 higher than 728 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 NCT02011945, the US trial registry maintained by the National Library of Medicine. NCT02011945 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.