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

Phase 2

Recruiting

• Conditions: skin cancer; 10040900; Melanoma

• Registration Number: NL-OMON52549
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 214

Inclusion Criteria

1. Patients must be willing and able to sign the informed consent and comply
with the study protocol.
2. Must be >=18 years of age.
3. Histologically confirmed primary malignant melanoma cutis with a Breslow
tumor depth >2.0 mm
4. WHO Performance Status <=1.
5. Women of childbearing potential (WOCBP) and fertile men must agree to use
effective contraceptive methods from screening until at least 90 days after the
IMO-2125 administration.

Exclusion Criteria

1. Known hypersensitivity to any oligodeoxynucleotide.
2. Active autoimmune disease requiring disease-modifying therapy at the time of
screening.
3. Pathologically confirmed loco-regional or distant metastasis.
4. Non-skin melanoma
5. Patients with another primary malignancy that has not been in remission for
at least 3 years with the exception of non-melanoma skin cancer, curatively
treated localized prostate cancer with non-detectable prostate-specific
antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial
lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
6. Active systemic infections requiring antibiotics.
7. Women who are pregnant or breast-feeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>SLN tumor status 7 days after injection.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Loco-regional and systemic immune profile with emphasis on recruitment and/or<br /><br>activation in the SLN of dendritic cell (DC), effector-T cell and Treg subsets,<br /><br>and melanoma antigen-specific T cell responses in peripheral blood.<br /><br>RFS and OS at 18 months, 24 months and 36 months after treatment.</p><br>