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NCT01079741 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Adjuvant Vaccine to Treat Melanoma Patients

A Phase 1 study of Melanoma, sponsored by Nina Bhardwaj.

Completed
Registry status
Phase 1
Development phase
34
Enrollment target
1
Study location

NCT01079741 is a Phase 1 study of Melanoma that has completed, run by Nina Bhardwaj. The registered enrollment target is 34 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01079741, a Phase 1 study of Melanoma, has completed, sponsored by Nina Bhardwaj.

COMPLETED
Registry status
Phase 1
Development phase
34 participants
Enrollment target
1
Study location

Study Summary

The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortality rate, even with initial optimal surgical resection. Effective adjuvant strategies are needed to increase the time to progression and to decrease the recurrence rate. Immunotherapy has long been recognized as a potential therapy for melanoma; the goal of adjuvant vaccine therapy is to train the endogenous immune system to recognize and target minimal residual disease.

Conditions Studied

Interventions

  • BIOLOGICAL NY-ESO-1 protein; Poly-ICLC; Montanide

Study Locations (1)

New York

  • New York University Langone Medical Center - New York

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2010-09
Est. Completion 2013-03-11
Phase Phase 1

Sponsor

Nina Bhardwaj

7 total trials

What the Registry Record Tells You About NCT01079741

The ClinicalTrials.gov registry entry for NCT01079741 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (95% lower). The listed sponsor is Nina Bhardwaj, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which NY-ESO-1 protein; Poly-ICLC; Montanide is the first listed.

NCT01079741 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT01079741 about?

NCT01079741 is a clinical study titled "Safety Study of Adjuvant Vaccine to Treat Melanoma Patients". The incidence of melanoma is increasing with an estimated incidence of 59,940 cases and an annual death rate of 8110 in 2007. Although patients diagnosed with early stage disease have an excellent clinical outcome, patients diagnosed with advanced or recurrent disease, continue to have a high mortal...

What is the current status of trial NCT01079741?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2010-09. Estimated completion is 2013-03-11.

What conditions does trial NCT01079741 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT01079741?

The interventions under investigation include: NY-ESO-1 protein; Poly-ICLC; Montanide (BIOLOGICAL).

Who is sponsoring clinical trial NCT01079741?

This trial is sponsored by Nina Bhardwaj, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01079741 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.