A Randomized Controlled Phase II Trial With Intradermal IMO-2125 in Pathological Tumor Stage (p) T3-4 cN0M0 Melanoma

Malignant Melanoma Clinical Trial

— INTRIM  

Official title:

A Randomized Controlled Phase II Clinical Trial With Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04126876
• Other study ID #: 2018/418
• Status: Recruiting
• Phase: Phase 2
• Start date: January 22, 2020
• Est. completion date: November 1, 2031

Study information

• Verified date: April 2021
• Source: VU University Medical Center
• Contact: Jessica CL Notohardjo, MD
• Phone: +3120 4444881
• Email: intrim[@]vumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, there is no widely used adjuvant treatment available to improve survival after surgical excision of a primary melanoma. In a previous study, loco-regional and systemic immune stimulations, as well as favourable clinical outcomes in terms of sentinel lymph node (SLN) tumor status and recurrence-free survival (RFS) in patients with clinical stage I-II melanoma who received a low dose of toll-like receptor 9 (TLR-9) CPG7909 (CpG-B ODN) intradermally at the excision site of the primary tumor prior to SLN biopsy (SNB) were described. In this phase II trial the investigators had investigated the clinical activity of a next-generation CpG-ODN, IMO-2125, and it's ability to induce loco-regional and systemic immune stimulation in pT3-4 cN0M0 melanoma patients who are scheduled to undergo a combined re-excision and SNB is

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: November 1, 2031
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
• Scheduled to undergo a combines re-excision and sentinel node biopsy (SNB)
• World Health Organization (WHO) Performance Status =1
• Agreement to use effective contraceptive methods from screening until at least 90 days after the IMO-2125 administration
• Written informed consent

Exclusion Criteria:

• Known hypersensitivity to any oligodeoxynucleotide
• Active auto-immune disease requiring disease-modifying therapy at the tumr of screening
• Pathologically confirmed loco-regional or distant metastasis
• Non-skin melanoma
• Patients with another primary malignancy (some exceptions)
• Active systemic infections requiring antibiotics
• Women who are pregnant or breast-feeding

Related Conditions & MeSH terms

• Malignant Melanoma
• Melanoma

Intervention

Drug:
• Tilsotolimod
Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
• Saline (0.9% sodium chloride)
Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).

Locations

Country	Name	City	State
Netherlands	VU Medical Centere	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
A.J.M. van den Eertwegh	Idera Pharmaceuticals, Inc.

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Koster BD, van den Hout MFCM, Sluijter BJR, Molenkamp BG, Vuylsteke RJCLM, Baars A, van Leeuwen PAM, Scheper RJ, Petrousjka van den Tol M, van den Eertwegh AJM, de Gruijl TD. Local Adjuvant Treatment with Low-Dose CpG-B Offers Durable Protection against Disease Recurrence in Clinical Stage I-II Melanoma: Data from Two Randomized Phase II Trials. Clin Cancer Res. 2017 Oct 1;23(19):5679-5686. doi: 10.1158/1078-0432.CCR-17-0944. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of tumor positive sentinal lymph node (SLN)	The rate of tumor positive sentinal lymph node (SLN)	Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Secondary	Immune response in the SLN and peripheral blood	Frequency and activation state of lymph node resident (LNR) conventional dendritic cells (DC) and melanoma antigen-specific T cell responses in the SLN and peripheral blood.	Seven days after the intradermal injection of Tilsotolimod (IMO-2125)
Secondary	Recurrence free survival (RFS)	The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.	At 5 years and 10 years after sentinel node biopsy (SNB)
Secondary	Overall survival	The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.	At 5 years and 10 years after sentinel node biopsy (SNB)