EUCTR2021-002360-51-NL
Active, not recruiting
Phase 1
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)
Antoni van Leeuwenhoek ziekenhuis0 sites69 target enrollmentNovember 22, 2021
Conditionsprimary clear cell renal cell cancer at risk for recurrence or distant metastasesMedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10038364Term: Renal and urinary tract neoplasms malignant and unspecifiedSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- primary clear cell renal cell cancer at risk for recurrence or distant metastases
- Sponsor
- Antoni van Leeuwenhoek ziekenhuis
- Enrollment
- 69
- Status
- Active, not recruiting
- Last Updated
- 4 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 clear cell RCC (measurable according to RECIST 1\.1\), that can be biopsied, and no history of distant metastases
- •TNM grading:
- •1\.cT1b\-cT2a grade 4 cN0 cM0
- •2\.cT2b grade 3 cN0 cM0
- •3\.cT3a grade 3\-4 cN0 cM0
- •4\.cT3b\-cT4 any grade cN0 cM0
- •5\.cT any cN1 (fully resectable) cM0
- •No other malignancies, except adequately treated and a cancer\-related life\-expectancy of more than 5 years
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 participate
- •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 Reactions (like mastocytosis)
Outcomes
Primary Outcomes
Not specified
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