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Neoantigen Vaccine Plus Locally Administered Ipilimumab and Systemic Nivolumab in Advanced Melanoma

NCT03929029 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2026-01-05

Study results available
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Summary

This research study is investigating a new type of personalized neoantigen vaccine, NeoVax, plus Montanide® in combination with Ipilimumab (Yervoy™) and Nivolumab (Opdivo®) as a possible treatment for cutaneous melanoma.

The drugs involved in this study are:

* Personalized Neoantigen Vaccine
* Poly-ICLC (Hiltonol®)
* Montanide®
* Ipilimumab (Yervoy™)
* Nivolumab (Opdivo®)

Conditions

Interventions

DRUG

Nivolumab (480 mg infusion)

Nivolumab is an antibody that prevent cancer cells from suppressing the immune response so that the body can attack and kill the cancer

BIOLOGICAL

NeoVax plus Montanide

Montanide® is an activator of immunity that enhances response to vaccination through slow release of the peptides from the injection site and its ability to create an inflammation and stimulate the recruitment of specific cells of your immune system. Montanide® will be mixed with the personalized neoantigen vaccine

DRUG

Ipilimumab

Ipilimumab is an antibody that prevent cancer cells from suppressing the immune response so that the body can attack and kill the cancer

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2022-12-27
Completion
2028-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT03929029 on ClinicalTrials.gov