Clinical Trials /

Dendritic Cell Vaccination in Patients With Advanced Melanoma

NCT03092453

Description:

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.

Related Conditions:
  • Melanoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Dendritic Cell Vaccination in Patients With Advanced Melamona
  • Official Title: Mature Dendritic Cell Vaccination Against Mutated Antigens in Patients With Advanced Melanoma

Clinical Trial IDs

  • ORG STUDY ID: 826433
  • SECONDARY ID: 17616
  • NCT ID: NCT03092453

Conditions

  • Melanoma

Interventions

DrugSynonymsArms
Mature DC vaccineMature DC vaccine
Cyclophosphamide 300mg/m^2Mature DC vaccine
PembrolizumabMature DC vaccine

Purpose

Single arm open label trial assessing the safety and tolerability of mDC3/8 Vaccine (Primer and Booster) in subjects with stage III and stage IV melanoma followed by treatment with Pembrolizumab.

Detailed Description

      After consent and screening, subjects will have apheresis performed at approximately day -7
      followed by cyclophosphamide 300mg/m^2 intravenously or by mouth on day -4 to -3. On Day 1
      the subject will receive parin vaccine dose (mature DC 7.5-15 million/peptide) followed by
      two booster doses (every 6 weeks) of mature DC 1-5 million/peptode. Re-staging will occur
      after the 3rd DC vaccine along with tumor biopsy and second apheresis. Anti PD-1 therapy
      (standard of care) will commence 7-8 weeks after the subjects' last DC vaccine.
    

Trial Arms

NameTypeDescriptionInterventions
Mature DC vaccineExperimentalMature DC 7.5-15 million/peptide given day 1, every six weeks for 2 doses followed by standard of care anti PD-1 therapy
  • Cyclophosphamide 300mg/m^2
  • Pembrolizumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed stage III and stage IV M1a/M1b/M1c melanoma

          -  Male or female patients age > 18 years

          -  ECOG performance status 0-2

          -  Required initial laboratory values (performed within 14 days prior to enrollment):

               -  WBC >3,000/mm3

               -  Hg 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 metastasis

          -  Active infection

          -  Prior malignancy (except non-melanoma skin cancer) within 3 years

          -  Pregnant or nursing (lactating) women

          -  Concurrent treatment with 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 BsAg, hepatitis C antibody, or HIV antibody
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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.
Safety Issue:
Description:Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay.

Secondary Outcome Measures

Measure:Clinical response
Time Frame:every three weeks for 18 weeks beginning after the subjects last DC vaccine
Safety Issue:
Description:using RECIST 1.1
Measure:Time to progression
Time Frame:10-28 days after the third vaccine through study completion approximately 30 weeks after the first DC vaccine
Safety Issue:
Description:using RECIST 1.1
Measure: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
Safety Issue:
Description:per CTCAE 4.0

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Pennsylvania

Last Updated

March 21, 2017