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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03929029
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Cutaneous Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 Montanide — BIOLOGICAL
    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
  • Ipilimumab — DRUG
    Ipilimumab is an antibody that prevent cancer cells from suppressing the immune response so that the body can attack and kill the cancer

Study Details

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®)

Key Dates

Start date
Nov 11, 2020
Status verified
Dec 2025
Primary completion
Dec 27, 2022
Completion
Sep 30, 2028

Study Design

Enrollment
11 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Nivolumab, NeoVax + Montanide, Ipilimumab 2.5 mg per injection site
    * 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
  • Experimental: Cohort 2: Nivolumab, NeoVax + Montanide, Ipilimumab 5.0 mg per injection site
    * 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

Primary Outcome Measure

Number of Participants With Dose-Limiting Toxicity (DLT) [ Time Frame: 7 weeks after first dose of NeoVax ]

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-

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Dana Farber Cancer Institute· Boston, MA

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