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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Study Type
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Leukaphresis 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Nina Bhardwaj

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Nina Bhardwaj, MD, PhD
Principal Investigator Affiliation Icahn School of Medicine at Mount Sinai

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Icahn School of Medicine at Mount Sinai, New York, New York




Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Tiara Hills



New York, New York


Active, not recruiting


New York University Langone Medical Center

New York, New York, 10016

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