Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
The Netherlands Cancer Institute
With
Bristol-Myers Squibb
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adults at least 18 years of age
World Health Organization (WHO) Performance Status 0 or 1
Cytologically or histologically confirmed resectable stage III melanoma with one or more macroscopic lymph node metastases (measurable according to RECIST 1.1), that can be biopsied, and no history of in-transit metastases within the last 6 months
No other malignancies, except adequately treated and a cancer-related life-expectancy of more than 5 years
Patient willing to undergo triple tumor biopsies and extra blood withdrawal during screening and in case of relapse
No prior immunotherapy targeting CTLA-4, PD-1 or PD-L1
No immunosuppressive medications within 6 months prior study inclusion
Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥1.5x109/L, Platelets ≥100 x109/L, Hemoglobin ≥5.5 mmol/L, Creatinine ≤1.5x ULN, AST ≤ 1.5 x ULN, ALT ≤ 1.5 x ULN, Bilirubin ≤1.5 X ULN
Normal LDH
Women of childbearing potential (WOCBP) must use appropriate method(s) of contra-ception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of ipilimumab + nivolumab
Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product
Women who are not of childbearing potential (i.e., who are postmenopausal), or surgically sterile as well as azoospermic men do not require contraception
Patient is capable of understanding and complying with the protocol requirements and has signed the Informed Consent document.
You may not be if
Distantly metastasized melanoma
History of in-transit metastases within the last 6 months
No measurable lesion according to RECIST 1.1
Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy
Prior CTLA-4 or PD-1/PD-L1 targeting immunotherapy
Radiotherapy prior or post-surgery
Patients will be excluded if they test positive for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody), indicating acute or chronic infection
Patients will be excluded if they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Allergies and Adverse Drug Reaction
* History of allergy to study drug components
* History of severe hypersensitivity reaction to any monoclonal antibody
Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity determination or adverse events;
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids;
Use of other investigational drugs before study drug administration 30 days and 5 half-times before study inclusion
Pregnant or nursing
Clareo Health | Optimal Neo-adjuvant Combination Scheme of Ipilimumab and Nivolumab
