Dendritic Cell Therapy With Pembrolizumab for Metastatic or Unresectable Melanoma

Conditions

• Stage III Cutaneous Melanoma AJCC v7
• Stage IIIA Cutaneous Melanoma AJCC v7
• Stage IIIB Cutaneous Melanoma AJCC v7
• Stage IIIC Cutaneous Melanoma AJCC v7
• Stage IV Cutaneous Melanoma AJCC v6 and v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cryosurgery — PROCEDURE
  Undergo cryosurgery
• Pembrolizumab — BIOLOGICAL
  IV
• Pheresis — PROCEDURE
  apheresis
• Therapeutic Autologous Dendritic Cells — BIOLOGICAL
  Intra-tumoral injection

Study Details

This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients with melanoma.

Key Dates

Start date

Nov 15, 2017

Status verified

Aug 2024

Primary completion

Jun 14, 2020

Completion

Jun 14, 2020

Study Design

Enrollment

7 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Phase I Schedule 1
  Phase I Schedule 1: Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production. Cycle 1 Day 1: Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes. Cycle 2 \& Cycle 3 Day 1: Pembrolizumab 200 mg is administered by IV over 30 minutes. Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3. Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
• Experimental: Phase I Schedule -1
  Phase I Schedule -1: Cycle length is 21 days with the exception of cycle 1 which may be extended an additional 7 days to allow for dendritic cell production. Cycle 1 Day 1: Patients undergo apheresis over 4 hours and pembrolizumab IV over 30 minutes. Cycle 2 \& Cycle 3 either Day 1 or Day 2 (within 36 hours of receiving pembrolizumab): patients undergo cryosurgery (injection of 30-60 x 10\^6 mDCs and an injection of 0.5 ml Prenar13 such that two distinct metastatic lesions are cryoablated, one during cycle 2 and the other during cycle 3. Cycle 4 Day 1 and all subsequent cycles for a maximum of 2 years: Pembrolizumab 200 mg is administered by IV over 30 minutes
• Experimental: Phase II Schedule
  Regimen depends upon the results of the Phase I portion of the study.

Primary Outcome Measure

Number of Participants Who Developed a DLT During the First 3 Cycles of Treatment. [ Time Frame: Up to 3 months (3 cycles of 21 days and an additional 7 days for Cycle 1) ]

Locations (1)

Related coverage on Hipa.ai

• Pembrolizumab with Dendritic Cell Therapy for Melanoma Shows Favorable Safety
  Pembrolizumab · Jun 12, 2025 · ClinicalTrials.gov

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