Status:
COMPLETED
Intradermal Injection of Anti-CTLA-4 in Patients With Stage I/II Melanoma
Lead Sponsor:
A.J.M. van den Eertwegh
Conditions:
Cutaneous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study evaluates the clinical safety and tolerability, and the immunological effects of local intradermal injection of tremelimumab in patients with clinical stage I/II melanoma patients undergoin...
Detailed Description
Although of limited therapeutic value, the SLN procedure has proven a useful prognostic tool for the assessment of melanoma relapse and mortality risk. Moreover, the SLN is of great value for the asse...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Clinical stage I/II melanoma patients, planned to undergo a sentinel lymph node biopsy (SNB)
- ECOG performance status 0 or 1
- White blood count (WBC) ≥ 3 x10\^9/L
- Platelet count ≥ 100 x10\^9/L
- Hemoglobin ≥ 6.5 mmol/L
- Serum creatinine ≤ 2.5 x ULN
- Total serum bilirubin, AST, ALT and LDH ≤ 2x ULN
Exclusion
- Non-oncology vaccine therapy used for prevention of infectious diseases (up-to) 4 weeks prior and/r 8 weeks after any dose of tremelimumab
- Prior treatment with a CD137 agonist or CTLA-4 inhibitor or agonist
- Uncontrolled infectious disease including negative testing for HIV, HBV, HCV
- Autoimmune disease
Key Trial Info
Start Date :
July 10 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2014
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04274816
Start Date
July 10 2012
End Date
February 27 2014
Last Update
February 18 2020
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