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NCT01094496 · ClinicalTrials.gov registry record · Phase 2

A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)

A Phase 2 study, sponsored by Celldex Therapeutics.

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01094496: Clinical Trial Phase 2 study, sponsored by Celldex Therapeutics.

NCT01094496 is a Phase 2 study that was terminated before completion, run by Celldex Therapeutics. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01094496, a Phase 2 study, was terminated before completion, sponsored by Celldex Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affects the immune systems.

Primary Outcome

The 2-year recurrence-free survival rate will be estimated based on the proportion of patients who are classified as alive and without documented disease recurrence at this time point.

Interventions

  • DRUG Chemotherapy
  • BIOLOGICAL CDX-1307 Vaccine Regimen

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2010-04
Est. Completion 2011-07
Phase Phase 2
Celldex Therapeutics

42 total trials

Why NCT01094496 stopped before completion

NCT01094496 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT01094496 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01094496 about?

NCT01094496 is a clinical study titled "A Study of the CDX-1307 Vaccine Regimen in Patients With Newly Diagnosed Muscle-Invasive Bladder Cancer (The "N-ABLE" Study)". The major purpose of this study is to examine the anti-tumor activity of the CDX-1307 vaccine regimen when it is given before and after bladder cancer surgery. The study will also provide information about the safety of the vaccine regimen when given in combination with chemotherapy, and how it affe...

What is the current status of trial NCT01094496?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2010-04. Estimated completion is 2011-07.

What interventions are being tested in trial NCT01094496?

The interventions under investigation include: Chemotherapy (DRUG), CDX-1307 Vaccine Regimen (BIOLOGICAL).

Who is sponsoring clinical trial NCT01094496?

This trial is sponsored by Celldex Therapeutics, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01094496's enrollment target sits among peer trials

3 2001st 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 NCT01094496, the US trial registry maintained by the National Library of Medicine. NCT01094496 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.