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NCT01176461 · ClinicalTrials.gov registry record · Phase 1

Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558

A Phase 1 study of Melanoma (Skin), sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
127
Enrollment target
1
Study location

NCT01176461 is a Phase 1 study of Melanoma (Skin) that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 127 participants, roughly in line with the 133-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT01176461, a Phase 1 study of Melanoma (Skin), has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

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

Study Summary

This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its effects on the patient's immune system and whether it will shrink their melanoma.

Conditions Studied

Interventions

  • DRUG Montanide ISA 51 VG
  • BIOLOGICAL gp100:209-217(210M)
  • BIOLOGICAL MART-1
  • BIOLOGICAL NY-ESO-1
  • BIOLOGICAL gp100:280-288(288V)

Study Locations (1)

Florida

  • H. Lee Moffitt Cancer Center and Research Institute - Tampa

Trial Details

FieldValue
Enrollment Target 127 participants
Start Date 2010-08-04
Est. Completion 2016-12-12
Phase Phase 1

What the Registry Record Tells You About NCT01176461

The ClinicalTrials.gov registry entry for NCT01176461 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 133-participant average among 30 other Melanoma (Skin) trials with a reported enrollment target. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma (Skin) appearing as the primary indexed condition, and to 5 interventions - of which Montanide ISA 51 VG is the first listed.

NCT01176461 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT01176461 about?

NCT01176461 is a clinical study titled "Multiple Class I Peptides & Montanide ISA 51 VG w Escalating Doses of Anti-PD-1 ab BMS936558". This is a pilot phase 1, open-label, single center, multi-dose, dose-escalation study of BMS-936558 in combination with or without a peptide vaccine. The purpose of this study is to test the side effects of an investigational vaccine with an immune booster. Investigators also wish to find out its e...

What is the current status of trial NCT01176461?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2010-08-04. Estimated completion is 2016-12-12.

What conditions does trial NCT01176461 study?

This clinical trial studies the following conditions: Melanoma (Skin).

What interventions are being tested in trial NCT01176461?

The interventions under investigation include: Montanide ISA 51 VG (DRUG), gp100:209-217(210M) (BIOLOGICAL), MART-1 (BIOLOGICAL), NY-ESO-1 (BIOLOGICAL), gp100:280-288(288V) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01176461?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01176461 being conducted?

This trial has 1 study location across Florida. 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 Editorial

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