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

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ClinicalTrials.gov Identifier: NCT04126876
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : April 15, 2021
Sponsor:
Collaborator:
Idera Pharmaceuticals, Inc.
Information provided by (Responsible Party):
A.J.M. van den Eertwegh, Amsterdam UMC, location VUmc

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A 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 : January 22, 2020
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2031


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 Name: 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 Name: Placebo




Primary Outcome Measures :
  1. The rate of tumor positive sentinal lymph node (SLN) [ Time Frame: Seven days after the intradermal injection of Tilsotolimod (IMO-2125) ]
    The rate of tumor positive sentinal lymph node (SLN)


Secondary Outcome Measures :
  1. Immune response in the SLN and peripheral blood [ Time Frame: 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.

  2. Recurrence free survival (RFS) [ Time Frame: 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.

  3. Overall survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04126876


Contacts
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Contact: Jessica CL Notohardjo, MD +3120 4444881 intrim@vumc.nl

Locations
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Netherlands
VU Medical Centere Recruiting
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
A.J.M. van den Eertwegh
Idera Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Tanja de Gruijl Amsterdam UMC, location VUmc
Principal Investigator: Alfons JM van den Eertwegh Amsterdam UMC, location VUmc
Publications:
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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: October 15, 2019    Key Record Dates
Last Update Posted: April 15, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas