Phase IIa trial with PD-L1 IO103 vaccination with montanide in patients with basal cell carcinoma.

Herlev and Gentofte Hospital0 个研究点目标入组 10 人开始时间: 2018年7月6日最近更新: 2021年6月14日

适应症

试验速览

暂无简介。

•At least 1 histological verified superficial or nodular basal cell carcinoma on the body or limbs of bigger than 14 mm in the longest diameter
•Willing to provide three 3 mm biopsies from the lesion/lesions
•Not previously treated with a hedgehog pathway inhibitor or retinoids
•ECOG performance score 0-1
•For women: Agreement to use contraceptive methods with a failure rate of < 1 % per year during the treatment period and for at least 26 weeks after the treatment.
•For men: Agreement to use contraceptive measures and agreement to refrain from donating sperm
•Understand and be willing to sign written informed consent after oral and written information about the protocol.
•Sufficient bone marrow function, i.e.
•Leucocytes = 1,5 x 109
•Granulocytes = 1,0 x 109
•Thrombocytes = 20 x 109
•Creatinine < 2.5 upper normal limit, i.e. < 300 µmol/l
•Sufficient liver function, i.e.
•ALAT < 2.5 upper normal limit, i.e. ALAT <112 U/lBilirubin < 30 U/l
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•The patient has a history of life-threatening or severe immune related adverse events on treatment with another immunotherapy and is considered to be at risk of not recovering
•The patient has a history of severe clinical autoimmune disease
•The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C
•The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders)
•The patient is pregnant or breastfeeding
•The patient is unable to voluntarily agree to participate by signed informed consent or assent
•The patient has an active infection requiring systemic therapy
•The patient has received a live virus vaccine within 30 days of planned start of therapy
•Known side effects to Montanide ISA-51
•Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus
•Concurrent treatment with other experimental drugs
•Any active autoimmune diseases e.g. autoimmune neutropenia, thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, scleroderma, myasthenia gravis, autoimmune glomerulonephritis, autoimmune adrenal deficiency, autoimmune thyroiditis etc.
•Severe allergy or anaphylactic reactions earlier in life.

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