Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dendritic Cell Vaccination in Patients With Advanced Melanoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03092453
Recruitment Status : Recruiting
First Posted : March 28, 2017
Last Update Posted : February 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Mature dendritic cell (DC) vaccine Drug: Cyclophosphamide 300mg/m^2 Drug: Pembrolizumab Phase 1

Detailed Description:

This is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with stage III and stage IV melanoma, followed by treatment with pembrolizumab (anti-PD-1 therapy).

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. Each study subject will receive cyclophosphamide 300mg/m^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory T cells. For each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. On Day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. Peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. Re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. Anti PD-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

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

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Mature dendritic cell (DC) vaccine
Mature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
 Biological: Mature dendritic cell (DC) vaccine
Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.

Drug: Cyclophosphamide 300mg/m^2
administered prior to subject's first DC dose

Drug: Pembrolizumab
administered 7-8 weeks after subject's last DC dose


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. [ Time Frame: day 1 through week 18. After week 18 every third week for 12 weeks. ]
    Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay.


Secondary Outcome Measures :
  1. Clinical response [ Time Frame: every three weeks for 18 weeks beginning after the subjects last DC vaccine ]
    using RECIST 1.1

  2. Time to progression [ Time Frame: 10-28 days after the third vaccine through study completion approximately 30 weeks after the first DC vaccine ]
    using RECIST 1.1

  3. Safety and side effects of vaccine per CTCAE 4.0 [ Time Frame: at time of consent through 30 days after the subjects last DC vaccine ]
    per CTCAE 4.0


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma. Measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted.
  • Male or female patients age greater than or equal to 18 years
  • ECOG (Eastern Cooperative Oncology Group) performance status 0-2

  • Required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator):

    • WBC (white blood cells) >3,000/mm3
    • Hg (hemoglobin) greater than or equal to 9.0 gm/dl
    • Platelets >75,000/mm3
    • Serum Bilirubin < 2.0 mg/dl
    • Serum Creatinine < 2.0 mg/dl
  • Subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial.
  • Provide written informed consent.

Exclusion Criteria:

  • Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilimumab, anti-PD1, or BRAF + MEK inhibitor combination) is permitted.
  • Active untreated CNS (central nervous system) metastasis
  • Active infection
  • Prior malignancy (except non-melanoma skin cancer) within 3 years
  • Pregnant or nursing (lactating) women
  • Concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted
  • Known allergy to eggs
  • Prior history of uveitis or autoimmune inflammatory eye disease
  • Known positivity for hepatitis B antibody, hepatitis C antibody, or HIV antibody
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03092453


Contacts
Layout table for location contacts
Contact: Gerald P Linette, MD, PhD 215-573-7032 glinette@upenn.edu
Contact: Abramson Cancer Center 855-216-0098 PennCancerTrials@emergingmed.com

Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Gerald P Linette, MD, PhD    215-573-7032    glinette@upenn.edu   
Contact: Abramson Cancer Center    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Layout table for investigator information
Principal Investigator: Gerald P Linette, MD, PhD University of Pennsylvania
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03092453    
Other Study ID Numbers: UPCC 17616, 826433
17616 ( Other Identifier: Abramson Cancer Center )
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: February 14, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Cyclophosphamide
Pembrolizumab
 Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological