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NCT02519322 · ClinicalTrials.gov registry record · Phase 2

Neoadjuvant and Adjuvant Checkpoint Blockade

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
53
Enrollment target

NCT02519322: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT02519322 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02519322, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
53 participants
Enrollment target

Study Summary

This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab alone or in combination with ipilimumab or relatlimab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Primary Outcome

Number of participants with the Pathologic response rate will be assessed by percent viable tumor cells, percent tumor necrosis, presence of fibrosis and melanoma proliferation as assessed by phosphohistone H3 from baseline, to on-treatment and surgical specimens.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • BIOLOGICAL Nivolumab
  • PROCEDURE Therapeutic Conventional Surgery
  • BIOLOGICAL Ipilimumab
  • BIOLOGICAL Relatlimab

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2016-02-02
Est. Completion 2023-01-26
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT02519322 record still lists

NCT02519322 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT02519322 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02519322 about?

NCT02519322 is a clinical study titled "Neoadjuvant and Adjuvant Checkpoint Blockade". This randomized phase II trial studies how well nivolumab with or without ipilimumab or relatlimab before surgery works in treating patients with stage IIIB-IV melanoma that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, and relatlimab, may help t...

What is the current status of trial NCT02519322?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2016-02-02. Estimated completion is 2023-01-26.

What interventions are being tested in trial NCT02519322?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Therapeutic Conventional Surgery (PROCEDURE), Ipilimumab (BIOLOGICAL), Relatlimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT02519322?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02519322's enrollment target sits among peer trials

53 1171st of 2000 higher than 820 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT02519322, the US trial registry maintained by the National Library of Medicine. NCT02519322 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.