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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02334735
Recruitment Status : Active, not recruiting
First Posted : January 8, 2015
Last Update Posted : October 26, 2020
Sponsor:
Collaborators:
NYU Langone Health
Memorial Sloan Kettering Cancer Center
Ludwig Institute for Cancer Research
Melanoma Research Alliance
Oncovir, Inc.
Information provided by (Responsible Party):
Nina Bhardwaj, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Melanoma Biological: DC Vaccine Biological: Montanide Vaccine Biological: Poly-ICLC Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2015
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma Vaccines

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 Name: 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: Montanide Vaccine
250 µg peptide (NY-ESO-1 and Melan-A/MART-1) and 1.1 mL Montanide ISA-51 VG

Biological: Poly-ICLC
1.4 mg
Other Name: Hiltonol®




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02334735


Locations
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United States, New York
New York University Langone Medical Center
New York, New York, United States, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Nina Bhardwaj
NYU Langone Health
Memorial Sloan Kettering Cancer Center
Ludwig Institute for Cancer Research
Melanoma Research Alliance
Oncovir, Inc.
Investigators
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Principal Investigator: Nina Bhardwaj, MD, PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: Nina Bhardwaj, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02334735    
Other Study ID Numbers: GCO 14-0780
First Posted: January 8, 2015    Key Record Dates
Last Update Posted: October 26, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nina Bhardwaj, Icahn School of Medicine at Mount Sinai:
Melanoma
Immunotherapy
DC Vaccine
Adjuvant Therapy
Immunogenicity
Additional relevant MeSH terms:
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Melanoma
Recurrence
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Disease Attributes
Pathologic Processes
Vaccines
Poly ICLC
Immunologic Factors
Physiological Effects of Drugs
Interferon Inducers