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NCT03425331 · ClinicalTrials.gov registry record · Phase 2

Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC

A Phase 2 study, sponsored by Dana-Farber Cancer Institute.

Terminated
Registry status
Phase 2
Development phase
5
Enrollment target

NCT03425331: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.

NCT03425331 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03425331, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.

TERMINATED
Registry status
Phase 2
Development phase
5 participants
Enrollment target

Study Summary

This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC). The drugs involved in this study are: * Ipilimumab * Nivolumab

Primary Outcome

Best response on treatment is based on RECISTv1.1 criteria: Complete Response (CR) is complete disappearance of all target lesions; Partial Response (PR) is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Both require confirmation no fewer than 4 weeks apart. Progressive Disease (PD) is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and the sum must also demonstra

Interventions

  • DRUG Nivolumab
  • DRUG Ipilimumab

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-04-10
Est. Completion 2021-11-28
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

Why NCT03425331 stopped before completion

NCT03425331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).

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

NCT03425331 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03425331 about?

NCT03425331 is a clinical study titled "Biomarkers of Response to Ipilimumab and Nivolumab in First-line NSCLC". This research study is studying two immunotherapy drugs as a possible treatment for advanced non-small cell lung cancer (NSCLC). The drugs involved in this study are: * Ipilimumab * Nivolumab

What is the current status of trial NCT03425331?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-04-10. Estimated completion is 2021-11-28.

What interventions are being tested in trial NCT03425331?

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

Who is sponsoring clinical trial NCT03425331?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03425331's enrollment target sits among peer trials

5 2000th of 2000 the lowest 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 NCT03425331, the US trial registry maintained by the National Library of Medicine. NCT03425331 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.