AzTrials
AzTrials

MelanomaPhase 2NCT02334735

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

A Phase 2 study testing DC Vaccine, Montanide Vaccine and Poly-ICLC in people with Melanoma, run by Nina Bhardwaj at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
DC Vaccine, Montanide Vaccine and Poly-ICLC
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
2 sitesUnited States
Study dates
1 Jul 2015to 15 Jul 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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)

Who cannot join

  • 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.
Show all 16Show fewer
  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • New York University Langone Medical Center

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Melanoma
Being tested
DC Vaccine, Montanide Vaccine, Poly-ICLC
Keywords
Melanoma, Immunotherapy, DC Vaccine, Adjuvant Therapy, Immunogenicity
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DC VaccineBiological

    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)

  • Montanide VaccineBiological

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

  • Poly-ICLCBiological

    Also called Hiltonol®

    1.4 mg

Study groups in NCT02334735
Study groupRoleWhat they receive
DC VaccineExperimentalStudy 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®).
Receives: Biological: DC Vaccine; Biological: Poly-ICLC
Montanide VaccineActive comparatorStudy 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®).
Receives: Biological: Montanide Vaccine; Biological: Poly-ICLC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Humoral immune response

    Humoral immune responses will be determined by the presence of NY-ESO-1 and Melan-A/MART-1 specific antibodies by ELISA

    Measured: up to 3 years

  2. Cytokine secretion

    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.

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2015 (estimated)
  2. Study start1 Jul 2015
  3. Primary completion15 Jul 2020
  4. Study completion15 Jul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02334735
Sponsor's protocol ID
GCO 14-0780
Status last verified
Sep 2022
First submitted
6 Jan 2015
Last updated
15 Sep 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DC Vaccine, Montanide Vaccine and Poly-ICLC in people with Melanoma, run by Nina Bhardwaj at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Humoral immune response (time frame: up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02334735.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in