A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

September 13, 2022 updated by: Nina Bhardwaj

Poly-ICLC Matured DC as an Adjuvant for NY-ESO-1 and Melan-A/MART-1 Peptide Vaccination Compared to Montanide® ISA-51 VG, in Study Subjects With Melanoma in Complete Clinical Remission But at High Risk of Disease Recurrence

Vaccine adjuvants are compounds used to increase specific immune responses to antigens, but have minimal toxicity or lasting immune effects on their own. This study investigates the use of dendritic cells as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides compared to Montanide® in study subjects with melanoma in complete clinical remission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase II open label, randomized two-arm study to evaluate the safety, tolerability, and immunogenicity of Poly-ICLC matured DCs as an adjuvant for NY-ESO-1 and Melan-A/MART-1 peptides (ARM A; DC Vaccine) compared to Montanide® ISA-51 VG (ARM B; Montanide Vaccine), both with systemic administration of Poly-ICLC on days 1 and 2 in study subjects with melanoma in complete clinical remission but at high-risk for disease recurrence.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10016
        • New York University Langone Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing and able to give written informed consent
  • Histologic diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed complete clinical remission without clinical evidence of disease
  • At least 4 weeks since surgery prior to first dosing of study agent

  • Required values for initial laboratory tests:

    • Neutrophil count ≥ 1.0 x 10⁹/L
    • Platelet count ≥ 80 x 10⁹/L
    • Hemoglobin ≥ 10.0 g/dL
    • Serum creatinine ≤ 2.0 x mg/dL
    • AST/ALT ≤ 2.0 x upper limit of institutional normal
    • Serum bilirubin ≤ 2.0 x upper limit of institutional normal
  • No active or chronic infection with HIV, Hepatitis B, or Hepatitis C
  • ECOG performance status of ≤ 2
  • Life expectancy of ≥ 6 months
  • Men and women, ≥ 18 years of age
  • Adequate venous access (for Leukapheresis and blood draws)

Exclusion Criteria:

  • Serious illnesses, e.g., serious infections requiring antibiotics
  • Previous bone marrow or stem cell transplant
  • Study subjects with known chronic infection with HIV, hepatitis B or C. Testing will be performed if a study subject exhibits clinical signs of infection or to confirm a history of infection
  • Study subjects with known autoimmune disease [e.g. SLE, RA] who have had significant symptoms within the past 3 years. Study subjects with vitiligo are not excluded
  • Metastatic disease to the central nervous system
  • Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, cervical carcinoma in situ, or incidental or localized prostate cancer treated with prostatectomy or radiation therapy, or stage I colon cancer. Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case- by- case basis with eligibility determined based on discussion with the Principal Investigator.
  • Prior chemotherapy or tumor vaccine therapy or biological therapy for treatment of melanoma. Subjects who received chemotherapy for the management of other malignancies are potentially eligible if the subject has not received chemotherapy in prior 5 years, remained disease free, and following discussion with and agreement by the principal investigator.
  • Radiation therapy or major surgery within 4 weeks prior to first dose of study agent
  • Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted
  • Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
  • Pregnancy or lactation. Pregnancy is associated with considerable immune suppression and this additional parameter may interfere with the evaluation of dendritic cell induced immune responses in melanoma study subjects. Pregnancy test must be negative on all women of reproductive potential at baseline (within 7 days of entry into the study) and they must agree to use birth control measures while on the study.
  • Study subjects previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible
  • Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of study agents hazardous or obscure the interpretation of AEs
  • Lack of availability of study subject for immunological and clinical follow up assessments
  • Children < 18 years of age
  • Allergy to shellfish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DC Vaccine

Study subjects receive KLH and NY-ESO-1 and Melan-A/MART-1 peptide-pulsed DCs:

DCs per peptide antigen (NY-ESO-1 and Melan-A/MART-1) and KLH will be administered intracutaneous as a single vaccine product followed by a subcutaneous injection of Poly-ICLC (Hiltonol®).
Biological: DC Vaccine

DCs pulsed with 100µg/mL peptide (NY-ESO-1 and Melan-A/MART-1)

10 to 15 x 106 DCs per peptide antigen (NY-ESO-1 and Melan-A/MART-1) (total not to exceed 50 x 10^6 cells)

Biological: Poly-ICLC
1.4 mg
Other Names:
  • Hiltonol®
ACTIVE_COMPARATOR: Montanide Vaccine

Study subjects receive KLH and NY-ESO-1 and Melan-A/MART-1 peptides and Montanide® ISA-51 VG:

Vaccine consisting of NY-ESO-1 peptide, Melan-A/MART-1 peptide, and KLH with an oil phase containing Montanide ISA-51 VG adjuvant will be administered subcutaneously as a single vaccine product followed by a subcutaneous injection of Poly-ICLC (Hiltonol®).
Biological: Poly-ICLC
1.4 mg
Other Names:
  • Hiltonol®
Biological: Montanide Vaccine
250 µg peptide (NY-ESO-1 and Melan-A/MART-1) and 1.1 mL Montanide ISA-51 VG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Humoral immune response
Time Frame: up to 3 years
Humoral immune responses will be determined by the presence of NY-ESO-1 and Melan-A/MART-1 specific antibodies by ELISA
up to 3 years
Cytokine secretion
Time Frame: up to 3 years
Cytokine secretion by NY-ESO-1 and Melan-A/MART-1 specific CD4+ and CD8+ T cells, as a measure of T cell activation, will be determined by flow cytometry analyses.
up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nina Bhardwaj

Collaborators

Memorial Sloan Kettering Cancer Center
NYU Langone Health
Ludwig Institute for Cancer Research
Oncovir, Inc.
Melanoma Research Alliance

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

July 15, 2020

Study Completion (ACTUAL)

July 15, 2020

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (ESTIMATE)

January 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 14-0780

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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