Immunological effects of local low-dose immunotherapy in early stage melanoma patients

Immune response in the sentinel node in melanoma patients after the pre-operative administration of immune modulators GM-CSF and / or CpG 7909

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63321797

Enrollment

Registered

2016-07-22

Start date

2004-06-01

Completion date

Unknown

Last updated

2026-08-10

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

Conditions

Clinical stage I-II melanoma Cancer

Interventions

There are three treatment arms and two saline (placebo) controlled arms. Treatment arm 1: Intradermal injection at the tumor excision site with 8 mg CpG-B (PF-3512676, formerly named CPG 7909, Coley

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with histologically proven primary melanoma, who are eligible for a SLN biopsy.

Exclusion criteria

Exclusion criteria: 1. Treated with chemotherapy or immunotherapy in the last ten years 2. Autoimmune diseases 3. Congenital or acquired immunodeficiency 4. Use of immunosuppressive medications

Design outcomes

Primary

Measure	Time frame
Immune status in the sentinel lymph node (SLN), specifically DC activation state and melanoma antigen specific T cells, measured using flow cytometry, interferon (IFN) gamma Elispot and tetramer analysis on immune cells that are harvested from the SLN at the day of the biopsy. .	—

Secondary

Measure	Time frame
Systemic anti melanoma activity measured using flow cytometry, IFN gamma Elispot and tetramer analysis on peripheral mononuclear blood cells from day -7, 0 and 14 (day 0 is the day of the SLN biopsy).	—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Aug 15, 2026