Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors

Inclusion Criteria

• Age ≥ 18
• The patient has metastatic solid tumors (NSCLC, colorectal cancer, urothelial cancer, breast cancer, ovarian cancer, malignant melanoma or HNSCC); progressive or recurrent disease on or following treatment with standard of care agents
• At least one measurable parameter according to RECIST 1.1.
• The patient has an ECOG performance status of 0 or 1
• Life expectancy of at least 3 months
• Prior PD1/PD-L1 allowed
• The patient is a female of childbearing potential with negative pregnancy test
• For fertile women: Agreement to use contraceptive methods with a failure rate of 1,5 ULN
• Serum creatinine ≤1,5 X ULN
• ANC (Absolute Neutrophil Count) ≥1,000/mcL
• Platelets ≥ 75,000 /mcL
• Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L
• Mandatory provision of archival tissue and blood for biomarker testing at baseline
• Mandatory provision of blood for biomarker testing during the study
• Signed declaration of consent after oral and written information about the protocol

Exclusion Criteria

• The patient has not recovered from surgery or is less than 4 weeks from major surgery
• 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 is expected to require any other form of systemic antineoplastic therapy or radiation therapy while receiving the treatment. However, radiation therapy treatment of non target lesion is allowed.
• 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 requires systemic steroids for management of immune-related adverse events experienced on another immunotherapy
• 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
• 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
• Concurrent treatment with Valproate or Xanthin Oxidase inhibitors
• Known side effects to Montanide ISA-51
• 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