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NeoLIPA: Neoadjuvant LTX-315 in combination with pembrolizumab in resectable stage III/IV melanoma
EU CTIS ID: 2023-508649-42-00
What this study is testing
Tumor response of neoadjuvant treatment. Meassured by rate of pathological response (pCR)
- 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
- Participant must be 18 years of age inclusive, at the time of signing the informed consent.
- Histologically confirmed, clinically detectable stage III-IV(M1a) melanoma, judged fully resectable and eligible for neoadjuvant treatment by consensus at a multidisciplinary tumor board. Patients with melanoma of cutaneous (including acral) or mucosal (including conjunctival) origin are eligible. Clinically detectable is defined as being apparent and measurable by radiological assessments or physical examination
- Measurable disease as per RECIST version 1.1 criteria.
- Judged medically fit to undergo the planned surgery by the surgical team.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one superficial cutaneous, subcutaneous or lymph node lesion available for injection with a maximum mean longest perpendicular diameter (LPD) of 5.0 cm.
You likely can't join if
- Uveal melanoma. Patients with acral, mucosal or conjunctival melanoma are eligible.
- Currently taking immunosuppressive agents or use of systemic corticosteroids (≥10 mg of prednisolone or equivalent) or other systemic immunosuppressive drugs within 28 days prior to study drug administration. Topical and inhaled corticosteroids are allowed.
- Have received a live vaccine within 30 days prior to first dose of treatment
- Have received an investigational drug within 4 weeks to day 1, or are scheduled to receive one during the treatment period
- Pregnant or breastfeeding.
- Any reason why, in the opinion of the investigator, the patient should not participate.
See the full eligibility criteria
Who can join
- Participant must be 18 years of age inclusive, at the time of signing the informed consent.
- Histologically confirmed, clinically detectable stage III-IV(M1a) melanoma, judged fully resectable and eligible for neoadjuvant treatment by consensus at a multidisciplinary tumor board. Patients with melanoma of cutaneous (including acral) or mucosal (including conjunctival) origin are eligible. Clinically detectable is defined as being apparent and measurable by radiological assessments or physical examination
- Measurable disease as per RECIST version 1.1 criteria.
- Judged medically fit to undergo the planned surgery by the surgical team.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have at least one superficial cutaneous, subcutaneous or lymph node lesion available for injection with a maximum mean longest perpendicular diameter (LPD) of 5.0 cm.
- Willing to undergo an additional tumor biopsy and submit biopsy and surgical specimens
- Adequate organ function as defined below: a. Hemoglobin > 9 g/dL b. Absolute neutrophil count (ANC) ≥ 1.0 x 109/L c. Platelet count ≥ 80 x 109/L e. Serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) f. AST and ALT ≤2.5 x ULN g. Albumin >30 g/L h. Serum creatinine ≤1.5 X ULN OR measured creatinine clearance (CL) >30 mL/min
- Capable of giving signed informed consent.
What rules you out
- Uveal melanoma. Patients with acral, mucosal or conjunctival melanoma are eligible.
- Currently taking immunosuppressive agents or use of systemic corticosteroids (≥10 mg of prednisolone or equivalent) or other systemic immunosuppressive drugs within 28 days prior to study drug administration. Topical and inhaled corticosteroids are allowed.
- Have received a live vaccine within 30 days prior to first dose of treatment
- Have received an investigational drug within 4 weeks to day 1, or are scheduled to receive one during the treatment period
- Pregnant or breastfeeding.
- Any reason why, in the opinion of the investigator, the patient should not participate.
- History of brain, bone, liver metastases or leptomeningeal metastases.
- Patients with stage IV disease having ≥4 metastatic sites.
- A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
- Active autoimmune disease requiring systemic immunomodulatory treatment. Replacement therapy (e.g. physiologic doses of corticosteroids, insulin, thyroxine) is allowed.
- Patient has history of, or any evidence of interstitial lung disease (ILD) or non-infectious pneumonitis that required systemic corticosteroids.
- Prior malignancy that require concurrent therapy.
- Allergy/hypersensitivity to prophylactic treatments; known hypersensitivity to pembrolizumab or LTX-315 or any of their excipients
- Previous treatment with anti-cancer immunotherapy, including (but not limited to) CTLA-4 or PD-1 inhibitors. Prior non-immunotherapy adjuvant treatment (e.g. dabrafenib + trametinib or radiotherapy), and regional therapy such as ECT or ILP is permitted (≥ 12 weeks prior to enrollment).
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, 18-64 years, 65+ 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.