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NCT02329847 · ClinicalTrials.gov registry record · Phase 1

A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies

A Phase 1 study, sponsored by Janssen Research & Development.

Completed
Registry status
Phase 1
Development phase
144
Enrollment target

NCT02329847 is a Phase 1 study that has completed, run by Janssen Research & Development. The registered enrollment target is 144 participants.

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The verdict

NCT02329847, a Phase 1 study, has completed, sponsored by Janssen Research & Development.

COMPLETED
Registry status
Phase 1
Development phase
144 participants
Enrollment target

Study Summary

The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). Once the dose is optimized, the combination will be assessed for Pharmacokinetics, Pharmacodynamics, and preliminary efficacy, further safety in participants with CLL/SLL, FL or DLBCL and in participants with Richter syndrome.

Interventions

  • DRUG Nivolumab
  • DRUG Ibrutinib

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2015-03-11
Est. Completion 2022-02-09
Phase Phase 1

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT02329847

The ClinicalTrials.gov registry entry for NCT02329847 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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

NCT02329847 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02329847 about?

NCT02329847 is a clinical study titled "A Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of the Combination of Ibrutinib With Nivolumab in Participants With Hematologic Malignancies". The purpose of this study is to determine the safety and to establish the recommended phase 2 dose (RP2D) for the combination of ibrutinib and nivolumab in participants with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), follicular cell lymphoma (FL) and diffuse large B-cell ly...

What is the current status of trial NCT02329847?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 144 participants. The study started on 2015-03-11. Estimated completion is 2022-02-09.

What interventions are being tested in trial NCT02329847?

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

Who is sponsoring clinical trial NCT02329847?

This trial is sponsored by Janssen Research & Development, which has 593 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.