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

Sponsor

A.J.M. van den Eertwegh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04126876

Collaborator

Idera Pharmaceuticals, Inc. (Industry)

214

Enrollment

Location

Arms

141.3

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Malignant Melanoma	Drug: Tilsotolimod Drug: Saline (0.9% sodium chloride)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

214 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Randomized Controlled Phase II Multicenter Clinical TrialA Randomized Controlled Phase II Multicenter Clinical Trial

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Persons that are masked/ blinded for which medication the patient receives: participant, treating physician/ team (including the person giving the intradermal injection) and peron who collects the data.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 22, 2020

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tilsotolimod (IMO-2125) 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).	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). Other Names: IMO-2125
Placebo Comparator: Placebo 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).	Drug: 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). Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Tilsotolimod (IMO-2125)

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).

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).

Other Names:

IMO-2125

Placebo Comparator: Placebo

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).

Drug: 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).

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

The rate of tumor positive sentinal lymph node (SLN) [Seven days after the intradermal injection of Tilsotolimod (IMO-2125)]
The rate of tumor positive sentinal lymph node (SLN)

Secondary Outcome Measures

Immune response in the SLN and peripheral blood [Seven days after the intradermal injection of Tilsotolimod (IMO-2125)]
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.
Recurrence free survival (RFS) [At 5 years and 10 years after sentinel node biopsy (SNB)]
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.
Overall survival [At 5 years and 10 years after sentinel node biopsy (SNB)]
The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VU Medical Centere	Amsterdam		Netherlands	1081 HV

Sponsors and Collaborators

A.J.M. van den Eertwegh
Idera Pharmaceuticals, Inc.

Investigators

Principal Investigator: Tanja de Gruijl, Amsterdam UMC, location VUmc
Principal Investigator: Alfons JM van den Eertwegh, Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

A.J.M. van den Eertwegh, Principal Investigator, Amsterdam UMC, location VUmc

ClinicalTrials.gov Identifier:

NCT04126876

Other Study ID Numbers:

2018/418

First Posted:

Oct 15, 2019

Last Update Posted:

Apr 15, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of Apr 15, 2021