Dendritic Cell Vaccination in Patients With Advanced Melanoma

NCT03092453 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: UPCC 17616, 82643317616
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

• Immune Response Measuring Increased Numbers of Peptide Specific T Cells as Calculated by the Tetramer Assay.

  Immune response measuring increased numbers of peptide specific T cells as calculated by the tetramer assay. The numbers of Peptide Specific T Cells are reported as the percent of CD8+ T cells that were p/HLA multimer positive for each antigen.

  Screening through week 21

• Safety and Tolerability of the Mature Dendritic Cell Vaccine (mDC3/8 Vaccines).

  Safety endpoint is type and number of adverse events. Tolerability endpoint is subject's completion or withdrawal from study treatment.

  End of Study visit (10-28 days after last DC vaccine)

Secondary Outcomes (3)

• Clinical Response to the mDC3/8 Vaccine(s)

  At the End of Study Treatment visit (~10-28 Days after the last DC vaccine)

• Time to Progression Post-mDC3/8 Vaccine Administration

  Up to 30 weeks after the first mDC3/8 Vaccine

• Safety and Side Effect Profile of the Dendritic Cell Vaccine (mDC3/8 Vaccines) Administered to Patients Given After a Single Dose of Cyclophosphamide.

  End of Study visit (10-28 days after last DC vaccine)

Study Arms (1)

Mature dendritic cell (DC) vaccine

EXPERIMENTAL

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; Drug: Cyclophosphamide 300mg/m^2; Drug: Pembrolizumab

Interventions

Mature dendritic cell (DC) vaccine BIOLOGICAL

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.

Mature dendritic cell (DC) vaccine

Cyclophosphamide 300mg/m^2 DRUG

administered prior to subject's first DC dose

Mature dendritic cell (DC) vaccine

Pembrolizumab DRUG

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

Mature dendritic cell (DC) vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Vaccines; Cyclophosphamide; pembrolizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Regulatory Lead
• Organization: University of Pennsylvania

psom-ind-ide@pobox.upenn.edu

215-573-7101

Study Officials

• Gerald P Linette, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 28, 2017
• Study Start: May 1, 2017
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Locations

US (1)