CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 11 enrolled
Drug / intervention
Nivolumab (480 mg infusion) +2 moredrug
Likely dose
Nivolumab (480 mg infusion)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03929029
NCT03929029Phase 1Active
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A Phase Ib Study of Neoantigen Vaccine (NeoVax Plus Montanide) in Combination With Nivolumab and Locally Administered Ipilimumab in Patients With Advanced Melanoma

Dana-Farber Cancer Institute·interventional·Posted Apr 26, 2019·Updated Jan 5, 2026

In Brief

A Phase 1 clinical trial evaluating Nivolumab (480 mg infusion), NeoVax plus Montanide, and 1 other intervention for Cutaneous Melanoma. Active but no longer recruiting, targeting 11 participants across 1 site.

Detailed 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®)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCutaneous Melanoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 1Active
2020202120222023202420252026202720282029
First PostedApr 26, 2019
Enrollment StartNov 11, 2020
Primary CompletionDec 27, 2022
Study CompletionSep 30, 2028
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 7.2 years ago

Interventions

Nivolumab (480 mg infusion)drug

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

NeoVax plus Montanidebiological

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

Ipilimumabdrug

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