Dendritic Cell Vaccination in Patients With Advanced Melanoma

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Cyclophosphamide; Pembrolizumab; Vaccines

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