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NCT02659059 · ClinicalTrials.gov registry record · Phase 2

Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
324
Enrollment target

NCT02659059: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT02659059 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 324 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02659059, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
324 participants
Enrollment target

Study Summary

The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC.

Primary Outcome

Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment.

Interventions

  • BIOLOGICAL Nivolumab
  • BIOLOGICAL Ipilimumab
  • DRUG Platinum Doublet Chemotherapy

Trial Details

FieldValue
Enrollment Target 324 participants
Start Date 2016-02-15
Est. Completion 2022-03-07
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT02659059 record still lists

NCT02659059 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (144% higher).

The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.

NCT02659059 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02659059 about?

NCT02659059 is a clinical study titled "Nivolumab in Combination With Ipilimumab (Part 1); Nivolumab Plus Ipilimumab in Combination With Chemotherapy (Part 2) as First Line Therapy in Stage IV Non-Small Cell Lung Cancer". The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy. The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab c...

What is the current status of trial NCT02659059?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 324 participants. The study started on 2016-02-15. Estimated completion is 2022-03-07.

What interventions are being tested in trial NCT02659059?

The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), Platinum Doublet Chemotherapy (DRUG).

Who is sponsoring clinical trial NCT02659059?

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 NCT02659059's enrollment target sits among peer trials

324 149th of 2000 higher than 1,851 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 NCT02659059, the US trial registry maintained by the National Library of Medicine. NCT02659059 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.