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A Randomized Controlled Phase II Clinical Trial with Intradermal IMO-2125 (Tilsotolimod) in pT3-4 cN0M0 Melanoma (Intrim 1 study)
EU CTIS ID: 2023-509461-20-00
What this study is testing
To investigate if local administration of IMO-2125 results in lower rates of tumor positive SLN in patients with pT3-4 cN0M0 melanoma.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients must be willing and able to sign the informed consent and comply with the study protocol.
- Must be ≥18 years of age.
- WHO Performance Status ≤1.
- Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- 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.
You likely can't join if
- Known hypersensitivity to any oligodeoxynucleotide.
- Active autoimmune disease requiring disease-modifying therapy at the time of screening.
- Pathologically confirmed loco-regional or distant metastasis.
- Non-skin melanoma
- 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).
- Active systemic infections requiring antibiotics.
See the full eligibility criteria
- Patients must be willing and able to sign the informed consent and comply with the study protocol.
- Must be ≥18 years of age.
- WHO Performance Status ≤1.
- Histologically confirmed primary malignant melanoma cutis with a Breslow tumor depth >2.0 mm
- 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.
- Known hypersensitivity to any oligodeoxynucleotide.
- Active autoimmune disease requiring disease-modifying therapy at the time of screening.
- Pathologically confirmed loco-regional or distant metastasis.
- Non-skin melanoma
- 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).
- Active systemic infections requiring antibiotics.
- Women who are pregnant or breast-feeding.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.