RUXOTEMITIDE for Malignant melanoma, resectable, stage III-IV

Inclusion criteria

• {"criterion_text":"- Participant must be 18 years of age inclusive, at the time of signing the informed consent."}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Measurable disease as per RECIST version 1.1 criteria."}
• {"criterion_text":"- Judged medically fit to undergo the planned surgery by the surgical team."}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Willing to undergo an additional tumor biopsy and submit biopsy and surgical specimens"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Capable of giving signed informed consent."}

Exclusion criteria

• {"criterion_text":"- Uveal melanoma. Patients with acral, mucosal or conjunctival melanoma are eligible."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Have received a live vaccine within 30 days prior to first dose of treatment"}
• {"criterion_text":"- Have received an investigational drug within 4 weeks to day 1, or are scheduled to receive one during the treatment period"}
• {"criterion_text":"- Pregnant or breastfeeding."}
• {"criterion_text":"- Any reason why, in the opinion of the investigator, the patient should not participate."}
• {"criterion_text":"- History of brain, bone, liver metastases or leptomeningeal metastases."}
• {"criterion_text":"- Patients with stage IV disease having ≥4 metastatic sites."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Active autoimmune disease requiring systemic immunomodulatory treatment. Replacement therapy (e.g. physiologic doses of corticosteroids, insulin, thyroxine) is allowed."}
• {"criterion_text":"- Patient has history of, or any evidence of interstitial lung disease (ILD) or non-infectious pneumonitis that required systemic corticosteroids."}
• {"criterion_text":"- Prior malignancy that require concurrent therapy."}
• {"criterion_text":"- Allergy/hypersensitivity to prophylactic treatments; known hypersensitivity to pembrolizumab or LTX-315 or any of their excipients"}
• {"criterion_text":"- 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)."}

Primary endpoints

• {"endpoint_text":"- Rate of pathologic complete response (cPR)","definition_or_measurement_approach":"Measured by rate of pathological response (pCR) as stated in the main objective."}

Secondary endpoints

• {"endpoint_text":"- Frequency, nature and severity of AE according to NCI CTCAE v 5.0: •\tAll AEs •\tLTX-315 treatment-related AEs •\tPembrolizumab treatment-related AEs The proportion of patients who received surgery as planned Number of doses of LTX-315 and pembrolizumab recieved","definition_or_measurement_approach":"Adverse events characterized and graded according to NCI CTCAE v5.0; includes overall AEs and treatment-related AEs for LTX-315 and pembrolizumab; also records surgery receipt and number of doses received."}
• {"endpoint_text":"- Objective response rate (ORR), i.e. rate of CR or PR as per RECIST version 1.1 prior to surgery Pathologic response rate (pCR + pPR) Rate of major pathologic response (MPR) defined as pCR and pnCR","definition_or_measurement_approach":"ORR assessed per RECIST v1.1 prior to surgery; pathologic response rates (pCR and pPR) and MPR definitions provided in endpoint text."}
• {"endpoint_text":"- Event free survival (EFS), defined as time from start of treatment to progression of disease per RECIST version 1.1 that precludes surgery, recurrence (local or distant) or death. Recurrence free survival (RFS), defined as the time from surgery to recurrence or death. Overall Survival (OS)","definition_or_measurement_approach":"EFS defined as time from treatment start to progression precluding surgery, recurrence or death; RFS defined from surgery to recurrence or death; OS measured as time to death from any cause."}
• {"endpoint_text":"- Patient reported outcomes (PRO)","definition_or_measurement_approach":"PROs collected as specified (details not provided in the JSON)."}

Norway

Earliest CTIS Part Ii Submission Date

27-03-2024

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

684

Number Of Sites

2

Number Of Participants

27

Primary sponsor

Full Name

Oslo University Hospital HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway

Third parties

• {"country":"","full_name":"Lytix Biopharma AS","duties_or_roles":"Monetary support","organisation_type":""}