PEGINTERFERON ALFA-2A for Metastatic melanoma

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Able and willing to give valid written informed consent\n- Progressive disease on prior treatment with f.e. BRAF-inhibitors, MEK-inhibitors or immunotherapy, including anti-PD1 treatment. Systemic therapy with BRAF-/MEK-inhibitors must have been discontinued for at least two weeks before start of study treatment. Treatment with immunotherapy must have been discontinued for at least four weeks before start of study treatment.\n- Histologically or cytologically proven metastatic skin melanoma\n- Melanoma must be at one of the following AJCC 2009 stages: - Unresectable (or residual) regional metastatic melanoma, i.e. in terms of AJCC 2009 classification unresectable stage III melanoma, or- Stage IV melanoma, i.e. distant metastatic disease (any T, any N, M1a, M1b or M1c), and normal LDH - Patients have failed on standard treatment options\n- Patients with brain metastases have to be neurologically stable for at least 2 months and should not use dexamethasone\n- Presence of measurable progressive disease according to RECIST version 1.1\n- Expected survival of at least 3 months\n- WHO performance status ≤1\n- Within the last 2 weeks prior to study day 1, vital laboratory parameters should be within normal range, except for the following laboratory parameters, which should be within the ranges specified: Lab Parameter Range Hemoglobin ≥ 6,0 mmol/l Granulocytes ≥ 1,500/μl Lymphocytes ≥ 700/μl Platelets ≥ 100,000/μl Creatinine clearance ≥ 60 min/ml Serum bilirubin ≤ 40 μmol/l ASAT and ALAT ≤ 5 x the normal upper limit LDH ≤ 2 x the normal upper limit\n- Viral tests must be performed at least 30 days before surgery: - Negative for HIV type 1/2, HTLV and TPHA - No HBV (hepatitis B virus) antigen or antibodies against HBc in the serum - No antibodies against HCV (hepatitis C virus) in the serum"}

Exclusion criteria

• {"criterion_text":"- Patients with brain metastases who are neurologically unstable and/or use dexamethasone\n- Lack of availability for follow-up assessments\n- Subjects with a condition requiring systemic chronic steroid therapy (≥ 10mg/day prednisone or equivalent) orany immunosuppressive therapy within 14 days prior to planned date for first dose of study treatment. Topical,inhaled, nasal and ophthalmic steroids, and adrenal replacement therapy are allowed.\n- Pregnancy or breastfeeding\n- Known allergy to penicillin or streptomycin (used during the culturing of T cells)\n- Other serious acute or chronic illnesses, e.g. active infections requiring antibiotics, bleeding disorders, or otherconditions requiring concurrent medications not allowed during this study\n- Clinically significant heart disease (NYHA Class III or IV)\n- Active immunodeficiency disease, autoimmune disease requiring immune suppressive drugs or autoimmune adverse events following treatment with checkpoint inhibitors. Vitiligo is not an exclusion criterion\n- Other malignancy within 2 years prior to entry into the study, except for treated non-melanoma skin cancer and in situ cervical carcinoma.\n- Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study\n- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the associated with the participation, study drug administration, or would impair the ability of the patient to receive protocol therapy"}

Primary endpoints

• {"endpoint_text":"- Evaluation of the safety and toxicity of TIL and nivolumab, followed by the evaluation of the safety and toxicity of PEG-IFNa, nivolumab and TIL, according to CTCAE 4.0 criteria. Given the nature and severity of the disease, toxicity grade 3 or less and SAE related to treatment, but that do not result in treatment termination, are considered acceptable for continuation of the study.","definition_or_measurement_approach":"Safety and toxicity assessed according to CTCAE v4.0 criteria; continuation criteria allow toxicity grade ≤3 and SAEs related to treatment that do not lead to treatment termination."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints include the evaluation of the disease control rate assessed by physical examination and imaging studies (CTand/or MRI) and will be evaluated according to RECIST 1.1 and immune related response criteria (irRC). Furthermore, overallsurvival (OS) and progression-free survival (PFS) will be evaluated and immune related parameters will be analysed. Quality of lifeis already measured by the DMTR and will be assessed.","definition_or_measurement_approach":"Disease control rate evaluated by physical exam and imaging (CT and/or MRI) per RECIST 1.1 and irRC; OS and PFS measured in standard fashion; immune-related parameters analysed; quality of life measured by DMTR."}

Netherlands

Latest Decision Or Authorization Date

12-08-2025

Number Of Sites

1

Number Of Participants

58

Primary sponsor

Full Name

Leids Universitair Medisch Centrum (LUMC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands