A randomized, double-blind, placebo-controlled phase III study to evaluate active immunization in adjuvant therapy of patients with stage IIIB and IIIC melanoma with natural dendritic cells pulsed with synthetic peptides

A randomized, double-blind, placebo-controlled phase III study to evaluate active immunization in adjuvant therapy of patients with stage IIIB and IIIC melanoma with natural dendritic cells pulsed with synthetic peptides - Melanoma patients Immunized with Natural DenDritic Cells (MIND-DC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45943

Enrollment

210

Registered

2016-01-14

Start date

2016-12-01

Completion date

Unknown

Last updated

2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma

Interventions

Patients in both arms will undergo a leukapheresis in cycle 1. The patients in the nDC vaccination arm (arm A) will receive 3 nDC injections intranodally (8x106 nDC) and 4 DTH challenges with nDC (0

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Histologically confirmed, resected stage III cutaneous melanoma, classified as stage IIIB or IIIC disease (AJCC 2009). - Radical lymph node dissection or sentinel node procedure (in case of patients without RLND because of limited sentinel-node positive disease) must be performed within 12 weeks prior to start of study. - Absence of distant metastases

Exclusion criteria

Exclusion criteria: - No concomitant use of immunosuppressive drugs orally or intravenously. Topical and intranasal steroids are permitted. - No uncontrolled infectious disease - No autoimmune disease. Patients with type 1 diabetes mellitus, hypothyroidism after autoimmune thyroiditis and skin disorders are not excluded.

Design outcomes

Primary

Measure	Time frame
The primary objective of this study is to determine whether adjuvant nDC vaccination improves 2-year RFS rate as compared to placebo in patients with resected stage IIIB or IIIC melanoma. Based on previous results on adjuvant DC vaccination in stage IIIB and IIIC melanoma patients, we expect that 70% of the DC vaccinated patients will remain recurrence free for 2 years. The anticipated 2-year RFS rate of the control arm is 50%.	—

Measure

Time frame

The primary objective of this study is to determine whether adjuvant nDC vaccination improves 2-year RFS rate as compared to placebo in patients with resected stage IIIB or IIIC melanoma. Based on previous results on adjuvant DC vaccination in stage IIIB and IIIC melanoma patients, we expect that 70% of the DC vaccinated patients will remain recurrence free for 2 years. The anticipated 2-year RFS rate of the control arm is 50%.

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Secondary

Measure	Time frame
The secondary objectives are to compare the median RFS, 2-year and median overall survival, adverse events profiles (safety), determine immunological responses and factors responsible for the variability of immune responses, quality of life and health economic aspects of nDC vaccination versus placebo.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)