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A Phase I Study With a Personalized NeoAntigen Cancer Vaccine in Melanoma

NCT01970358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-29

Study results available
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Summary

This research study is evaluating a new type of melanoma vaccine called "Personalized NeoAntigen Cancer Vaccine". The purpose of this study is to determine if it is possible to make and administer safely a vaccine against melanoma by using information gained from specific characteristics of the participant's own melanoma. It is known that melanomas have mutations (changes in genetic material) that are specific to an individual patient and tumor. These mutations can cause the tumor cells to produce proteins that appear very different from the body's own cells. It is possible that these proteins used in a vaccine may induce strong immune responses, which may help the participant's body fight any tumor cells that could cause the melanoma to come back in the future. The study will examine the safety of the vaccine when given at several different time points and will examine the participant's blood cells for signs that the vaccine induced an immune response.

Conditions

Interventions

BIOLOGICAL

Poly-ICLC

BIOLOGICAL

Peptides

Sponsors & Collaborators

  • Patrick Ott, MD, PhD

    lead OTHER

Principal Investigators

  • Patrick Ott, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-09-30
Completion
2018-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970358 on ClinicalTrials.gov