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

Primary Purpose

Malignant Melanoma

Status

Recruiting

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

Tilsotolimod

Saline (0.9% sodium chloride)

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

VU Medical CentereRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tilsotolimod (IMO-2125)

Placebo

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The rate of tumor positive sentinal lymph node (SLN)

Secondary Outcome Measures

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.

Recurrence free survival (RFS)

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.

Overall survival

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.

Full Information

NCT ID

NCT04126876

First Posted

October 10, 2019

Last Updated

April 14, 2021

Sponsor

A.J.M. van den Eertwegh

Collaborators

Idera Pharmaceuticals, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04126876

Brief Title

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

Acronym

INTRIM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Recruiting

Study Start Date

January 22, 2020 (Actual)

Primary Completion Date

November 1, 2021 (Anticipated)

Study Completion Date

November 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

A.J.M. van den Eertwegh

Collaborators

Idera Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malignant Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

A Randomized Controlled Phase II Multicenter Clinical Trial

Masking

ParticipantCare ProviderInvestigator

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.

Allocation

Randomized

Enrollment

214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tilsotolimod (IMO-2125)

Arm Type

Experimental

Arm Description

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).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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).

Intervention Type

Drug

Intervention Name(s)

Tilsotolimod

Other Intervention Name(s)

IMO-2125

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Saline (0.9% sodium chloride)

Other Intervention Name(s)

Placebo

Intervention Description

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).

Primary Outcome Measure Information:

Title

The rate of tumor positive sentinal lymph node (SLN)

Description

The rate of tumor positive sentinal lymph node (SLN)

Time Frame

Seven days after the intradermal injection of Tilsotolimod (IMO-2125)

Secondary Outcome Measure Information:

Title

Immune response in the SLN and peripheral blood

Description

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.

Time Frame

Seven days after the intradermal injection of Tilsotolimod (IMO-2125)

Title

Recurrence free survival (RFS)

Description

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to first documentation of recurrence.

Time Frame

At 5 years and 10 years after sentinel node biopsy (SNB)

Title

Overall survival

Description

The length of time from intradermal injection of Tilsotolimod (IMO-2125) to death from any cause.

Time Frame

At 5 years and 10 years after sentinel node biopsy (SNB)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jessica CL Notohardjo, MD

Phone

+3120 4444881

intrim@vumc.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tanja de Gruijl

Organizational Affiliation

Amsterdam UMC, location VUmc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alfons JM van den Eertwegh

Organizational Affiliation

Amsterdam UMC, location VUmc

Official's Role

Principal Investigator

Facility Information:

Facility Name

VU Medical Centere

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28972083

Citation

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.

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

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