NL-OMON52016
Recruiting
Phase 2
Prospective, randomized, neoadjuvant phase II study with combination immuno-oncology in primary clear cell renal cell cancer at risk for recurrence or distant metastases (NESCIO-trial; M21NSC; CA209-6DJ) - NESCIO
Antoni van Leeuwenhoek Ziekenhuis0 sites46 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- clear cell renal cell carcinoma
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 46
- Status
- Recruiting
- Last Updated
- last year
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 clear cell RCC (measurable according to
- •RECIST 1\.1\), that can be biopsied, and no history of distant metastases
- •Intermediate to high risk will be based on clinical TNM and biopsy nuclear
- •grade. These are:
- •1\. cT1b\-cT2a grade 4 cN0 cM0
- •2\. cT2b grade 3\-4 cN0 cM0
- •3\. cT3 any grade cN0 cM0
- •4\. cT4 any grade cN0 cM0
Exclusion Criteria
- •Distantly metastasized RCC • Brain metastases (based on symptoms) • Non\-clear
- •cell RCC • 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 or LAG\-3 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; if
- •treated and being at least one year free from HCV patients are allowed to
Outcomes
Primary Outcomes
Not specified
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