Metastatic malignant melanoma MedDRA version: 21.1 Level: PT Classification code 10027480 Term: Metastatic malignant melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: PD-L1 (Long1)
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: Montanide ISA51
CAS Number: 190396-06-6
Other descriptive name: MONTANIDE ISA51
Sponsors
Center for Cancer Immune Therapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 16 2. The patient has unrespectable or metastatic melanoma with progressive, persistent or recurrent disease on or following treatment with standard of care agents. 3. The patient is candidate for Nivolumab monotherapy. 4. At least one measurable parameter according to RECIST 1.1. 5. The patient has an ECOG Performance status of 0 or 1. 6. The patient is a female of childbearing potential with negative pregnancy test. 7. Women agreement to use contraceptive methods with a failure rate of 1,5 ULN c. Serum creatinine =1,5 X ULN d. ANC (Absolute Neutrophil Count) =1,000/mcL e. Platelets = 75,000 /mcL f. Hemoglobin = 9 g/dL eller = 5.6 mmol/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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1. The patient has previously received monotherapy Nivolumab. 2. The patient has not recovered to grade 0-1 from adverse events due to prior chemotherapy, radioactive or biological cancer therapy. 3. The patient has not recovered from surgery or is less than 4 weeks from major surgery. 4. 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. 5. The patient is expected to require any other form of systemic antineoplastic therapy while receiving the treatment. 6. The patient has a history of severe clinical autoimmune disease. 7. The patient has a history of pneumonitis, organ transplant, human immunodeficiency virus positive, active hepatitis B or hepatitis C. 8. The patient requires systemic steroids for management of immune-related adverse events experienced on another immunotherapy. 9. The patient has active CNS metastases and/or carcinomatous meningitis. However patients with subclinical brain metastases < 1 cm can be included (maximum of 4 metastases < 1 cm). (Patients with previously treated brain metastases may participate provided they are clinically stable. Patients with untreated brain metastasis will be excluded). 10. The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders). 11. The patient is pregnant or breastfeeding. 12. The patient is unable to voluntarily agree to participate by signed informed consent or assent. 13. The patient has an active infection requiring systemic therapy. 14. The patient has received a live virus vaccine within 30 days of planned start of therapy. 15. Known side effects to Montanide ISA-51. 16. Significant medical disorder according to investigator; e.g. severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus. 17. Concurrent treatment with other experimental drugs. 18. 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. 19. Severe allergy or anaphylactic reactions earlier in life.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asses safety and tolerability of combination therapy with Nivolumab and the PD-L1/IDO peptide vaccine with the adjuvant Montanide in patients with metastatic malignant melanoma;Secondary Objective: Assess the immunologic response to vaccination with PD-L1/IDO peptide in periferal blood before, during and after treatment. ;Primary end point(s): Safety and tolerability, primary end point will be assessed according to CTCAE version 4.0. ;Timepoint(s) of evaluation of this end point: First evaluation at baseline (prior first vaccination), then before every second subsequent vaccination and finaly during follow up (2 visits) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Development of a measurable vaccine related immune response;Timepoint(s) of evaluation of this end point: Blood samples are drawn at baseline and thereafter every third month. Delayed type hypersensitivity skin test is performed after 6 vaccinations. Tumor biopsies are taken at baseline and after 6 vaccinations. | — |
Countries
Denmark
Contacts
Public ContactTrial Executive
Center for Cacerimmunetherapy, Herlev and Gentofte University Hospital
Outcome results
None listed