NL-OMON42085
Recruiting
Not Applicable
Feasibility Study to Identify the Optimal Adjuvant Combination Scheme of Ipilimumab and Nivolumab in resectable stage III melanoma patients (OpACIN) - Study to identify the Optimal Adjuvant Scheme in melanoma patients (OpACIN)
ederlands Kanker Instituut0 sites20 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- melanoma
- Sponsor
- ederlands Kanker Instituut
- Enrollment
- 20
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults at least 18 years of age
- •World Health Organization (WHO) Performance Status 0 or 1
- •Histologically confirmed resectable stage III melanoma with palpable lymph node metastases and no history or active in\-transit metastases within the last 6 months
- •Patient willing to undergo triple tumor biopsies during screening and in case of disease progression
- •No prior immunotherapy targeting CTLA\-4, PD\-1 or PD\-L1
- •No immunosuppressive medications within 6 months prior study inclusion
- •Presence of at least two of the defined HLA alleles
- •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 contraception. 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
Exclusion Criteria
- •Distantly metastasized melanoma
- •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 within this trial
- •Patients will be excluded if they are positive test 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;
Outcomes
Primary Outcomes
Not specified
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