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NCT01119508 · ClinicalTrials.gov registry record · Phase 2

Ipilimumab + Temozolomide in Metastatic Melanoma

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

Completed
Registry status
Phase 2
Development phase
64
Enrollment target

NCT01119508: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01119508 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 64 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01119508, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
64 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if combining ipilimumab and temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that are related to your immune system.

Primary Outcome

6-month progression free survival rate is defined as the number of participants without progression per RECIST 1.0 6 months after starting study treatment.

Interventions

  • DRUG Ipilimumab
  • DRUG Temozolomide

Trial Details

FieldValue
Enrollment Target 64 participants
Start Date 2010-05
Est. Completion 2016-08
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01119508 record still lists

NCT01119508 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (52% lower).

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

NCT01119508 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01119508 about?

NCT01119508 is a clinical study titled "Ipilimumab + Temozolomide in Metastatic Melanoma". The goal of this clinical research study is to learn if combining ipilimumab and temozolomide can help to control metastatic melanoma. The safety of this drug combination will be studied. Researchers would also like to study how this therapy affects the levels of certain chemicals in the blood that ...

What is the current status of trial NCT01119508?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2010-05. Estimated completion is 2016-08.

What interventions are being tested in trial NCT01119508?

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

Who is sponsoring clinical trial NCT01119508?

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 NCT01119508's enrollment target sits among peer trials

64 996th of 2000 higher than 992 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 NCT01119508, the US trial registry maintained by the National Library of Medicine. NCT01119508 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.