NIVOLUMAB for Metastatic renal cell carcinoma

Stratification factors

• PDL1 status

Inclusion criteria

• {"criterion_text":"-Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component"}
• {"criterion_text":"-Fertile men with a female partner of childbearing potential must agree to use malecondom plus spermicide. Also, it is recommended their women of childbearing potentialpartner use a highly effective method of contraception"}
• {"criterion_text":"-Female subjects of childbearing potential must not be pregnant at screening"}
• {"criterion_text":"-Intermediate- or poor-risk mRCC as defined by IMDC classification."}
• {"criterion_text":"-Adult male or female patients (≥ 18 years of age at inclusion)."}
• {"criterion_text":"-Karnofsky Performance Status (KPS) ≥70%."}
• {"criterion_text":"-Adequate organ and marrow function, according to investigator assessment and a.Absolute neutrophil count (ANC) ≥ 1000/μL (≥ 1.5 GI/L) b.Platelets ≥ 100,000/μL (≥ 100 GI/L) c.Hemoglobin ≥ 8 g/dL (≥ 80 g/L) d.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 xULN. e.Calculated creatinine clearance ≥ 30 mL/min (≥ 0.67 mL/sec) using the CKD-EPI equation"}
• {"criterion_text":"-Patient should understand, sign, and date the written informed consent form prior to anyprotocol-specific procedures performed"}
• {"criterion_text":"-Patient should be able and willing to comply with study visits and procedures as per protocol"}
• {"criterion_text":"-Patients must be affiliated to a social security system or beneficiary of the same"}
• {"criterion_text":"-Female patients must either be of non-reproductive potential or must have a negativeserum pregnancy test within 14 days prior to the administration of study drug.Childbearing potential women must have agreed to use at least one highly effectivecontraceptive method during treatment on this trial and for up to 6 months after the lastdose of study treatment"}

Exclusion criteria

• {"criterion_text":"-Prior systemic anticancer therapy for mRCC including investigational agents. Note: One prior systemic adjuvant therapy is allowed for completely resected RCC and ifrecurrence occurred at least 6 months after the last dose of adjuvant therapy."}
• {"criterion_text":"-Uncontrolled brain metastases (adequately treated with radiotherapy and/orradiosurgery prior to randomization are eligible). Subjects who are neurologicallysymptomatic as a result of their CNS metastasis or are receiving systemic corticosteroidtreatment (prednisone equivalent > 10 mg/day) at the planned time of randomizationare not eligible"}
• {"criterion_text":"-Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH ordirect oral anticoagulants (DOAC), if considered safe by investigator assessment"}
• {"criterion_text":"-The subject has uncontrolled, significant intercurrent or recent illness such as thefollowing conditions: a.Cardiovascular i.Congestive heart failure (CHF) class III or IV as defined by the NewYork Heart Association, unstable angina pectoris, myocardialinfarction, serious cardiac arrhythmias (e.g., ventricular flutter,ventricular fibrillation, Torsades de pointes). ii.Uncontrolled hypertension despite optimal antihypertensive treatment. iii.Stroke, or other symptomatic ischemic event or severe thromboembolicevent (e.g., symptomatic pulmonary embolism [PE], incidental PE isacceptable if deemed safe by the investigator) within 3 months beforerandomization. b.Active GI bleeding or symptomatic Gastrointestinal (GI) tract obstruction c.Clinically significant bleeding including uncontrolled hematuria, hematemesis,or hemoptysis d.Autoimmune disease that has been symptomatic or requiredimmunosuppressive systemic treatment within the past two years from the dateof randomization. Note: Patients with a history of Crohn’s disease or ulcerative colitis are always excluded e.Any condition requiring systemic treatment with either corticosteroids (> 10 mgdaily prednisone equivalent) or other immunosuppressive medications within14 days of randomization. Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted.Adrenal replacement steroid doses > 10 mg daily prednisone equivalent arepermitted. Transient short-term use of systemic corticosteroids for allergicconditions (e.g., contrast allergy) is also allowed. f.Active infection requiring systemic treatment. g.Major surgery (e.g., nephrectomy, GI surgery, removal of brain metastasis)within 4 weeks prior to randomization or serious non-healing wound/ulcer/bonefracture. disorders"}
• {"criterion_text":"-Pregnant or breastfeeding females."}
• {"criterion_text":"-Any other active malignancy at time of randomization or diagnosis of anothermalignancy within 3 years prior to randomization that requires active treatment, exceptfor locally curable cancers that have been apparently cured"}
• {"criterion_text":"-Persons deprived of their freedom or under guardianship, or for whom it would be impossible to undergo the medical follow-up required by the trial, for geographic, socialor psychological reasons"}
• {"criterion_text":"-Überempfindlichkeit gegen einen der Wirkstoffe oder gegen einen der Hilfsstoffe, die während der Studie verabreicht werden"}

Primary endpoints

• {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Progression-free survival according to RECIST 1.1 NB: Progression-free survival is a co-primary endpoint in the PDL1(-) population","definition_or_measurement_approach":"Measured according to RECIST 1.1 criteria"}
• {"endpoint_text":"-Objective Response Rate (ORR) according to RECIST 1.1","definition_or_measurement_approach":"Measured according to RECIST 1.1 criteria"}
• {"endpoint_text":"-Percentage of patients experiencing a deterioration of ≥3 points on the NFKSI-19 scorein the first twelve months after randomization; Mean Change from Baseline in EQ-VAS andResponse frequencies for the EQ-5D-5L dimensions","definition_or_measurement_approach":"Health-related quality of life instruments: NFKSI-19 deterioration ≥3 points; mean change from baseline in EQ-VAS; response frequencies for EQ-5D-5L dimensions"}
• {"endpoint_text":"-Median treatment duration (per treatment)","definition_or_measurement_approach":""}
• {"endpoint_text":"-Time to subsequent systemic therapy, defined as the time from the date ofrandomisation to the date of next subsequent systemic therapy. In absence of subsequenttherapy, the data will be censored at the date of last follow-up; Patients dying without receivinga subsequent treatment will be censored at the date of death.","definition_or_measurement_approach":"Defined as time from randomisation to start of next subsequent systemic anticancer therapy; censoring described in endpoint text"}
• {"endpoint_text":"-Percentage of subjects experiencing grade 3-5 AEs, percentage of patientsexperiencing treatment-related grade 3-5 AEs, Percentage of patients experiencing AE grade≥2leading to the modification of administration of a study drug","definition_or_measurement_approach":"Safety graded by CTCAE (grade 3-5 events and treatment-related events); AE grade ≥2 leading to modification captured"}
• {"endpoint_text":"-Health economic evaluation through the incremental cost per Quality-adjusted life year(QALY), incremental net monetary benefit in the two patient subgroups (PDL1(+) and PDL1(-)respectively)","definition_or_measurement_approach":"Health economic analysis using incremental cost per QALY and incremental net monetary benefit in PD-L1 subgroups"}

France

Earliest CTIS Part Ii Submission Date

12-12-2023

Latest Decision Or Authorization Date

22-12-2025

Processing Time Days

741

Number Of Participants

450

Czechia

Earliest CTIS Part Ii Submission Date

22-04-2024

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

520

Number Of Participants

100

Netherlands

Earliest CTIS Part Ii Submission Date

26-08-2024

Latest Decision Or Authorization Date

22-11-2024

Processing Time Days

88

Number Of Participants

70

Austria

Earliest CTIS Part Ii Submission Date

26-08-2024

Latest Decision Or Authorization Date

25-11-2024

Processing Time Days

91

Number Of Participants

15

Finland

Earliest CTIS Part Ii Submission Date

03-04-2025

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

106

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

20-02-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

386

Number Of Participants

150

Germany

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

30-04-2026

Processing Time Days

220

Number Of Participants

100

Greece

Earliest CTIS Part Ii Submission Date

16-10-2025

Latest Decision Or Authorization Date

19-01-2026

Processing Time Days

95

Number Of Participants

80

Denmark

Earliest CTIS Part Ii Submission Date

28-10-2025

Latest Decision Or Authorization Date

05-02-2026

Processing Time Days

100

Number Of Participants

20

Belgium

Earliest CTIS Part Ii Submission Date

31-12-2025

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

76

Number Of Participants

68

Primary sponsor

Full Name

Institut Gustave Roussy

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France