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Checkpoint Inhibitor

NeoVax + Immunotherapy for Melanoma

Phase 1

Waitlist Available

Led By Patrick A Ott, MD, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have histologically confirmed melanoma that is unresectable stage III or stage IV; at least one site of disease must be resectable, partially-resectable, or amenable to core biopsies to provide tumor tissue for sequence analysis

ECOG performance status of 0 or 1

Must not have

Uncontrolled intercurrent illness

A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new type of vaccine, NeoVax, in combination with other drugs to see if it can treat melanoma.

Who is the study for?

Adults over 18 with advanced melanoma that can't be removed by surgery or is stage III/IV. They must have normal organ/marrow function, no HIV/AIDS, and not be pregnant/nursing. Participants should agree to use contraception and have recovered from previous treatments.

What is being tested?

The trial tests a personalized neoantigen vaccine (NeoVax) plus Montanide with Ipilimumab (Yervoy) and Nivolumab (Opdivo). It aims to see if this combination helps treat unresectable or stage III/IV melanoma more effectively than current methods.

What are the potential side effects?

Possible side effects include immune system reactions like inflammation in organs, allergic responses to the vaccines, fatigue, skin changes such as alopecia or vitiligo, digestive issues, blood-related problems, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My melanoma cannot be fully removed by surgery but a part can be biopsied.

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I am fully active or can carry out light work.

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My blood tests show normal organ function and I don't have severe anemia or liver/kidney issues.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am not breastfeeding if I start treatment with Ipilimumab, Nivolumab, and a personalized vaccine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unmanaged ongoing illnesses.

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I haven't taken steroids or immune-weakening drugs in the last 2 weeks.

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I have active cancer spread to my brain or its coverings.

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I haven't taken any cancer or immunosuppressive drugs in the last 6 months.

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I am scheduled for a major surgery soon.

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I have an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose-Limiting Toxicity (DLT)

Secondary study objectives

Number of Patients With Disease Progression/Recurrence

Number of Patients With Objective Response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: Nivolumab, NeoVax + Montanide, Ipilimumab 5.0 mg per injection siteExperimental Treatment3 Interventions

* Patients will receive Nivolumab at a 480 mg flat dose I.V. infusion every 4 weeks (28 days) * Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21 * Patients will receive concurrent Ipilimumab (5.0 mg per injection site) on weeks 12, 15, 18, and 21

Group II: Cohort 1: Nivolumab, NeoVax + Montanide, Ipilimumab 2.5 mg per injection siteExperimental Treatment3 Interventions

* Patients will receive Nivolumab at a 480 mg flat dose I.V. infusion every 4 weeks (28 days) * Patients will receive NeoVax plus Montanide injection on weeks 12, 15, 18, and 21 * Patients will receive concurrent Ipilimumab (2.5 mg per injection site) on weeks 12, 15, 18, and 21

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~3140

0 / 12Eligibility criteria met