Actively Recruiting
First Line Randomized Study Comparing Immune Checkpoint Inhibitor Combinations and Targeted Therapy Combinations in Patients With Metastatic Renal Cell Carcinoma
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-01-16
1250
Participants Needed
46
Research Sites
420 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
E
European Commission
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for metastatic clear cell renal cell carcinoma (RCC), a type of kidney cancer. The study compares two combination therapies: immune checkpoint inhibitor with immune checkpoint inhibitor (ICI-ICI) versus immune checkpoint inhibitor with vascular endothelial growth factor receptor tyrosine kinase inhibitor (ICI-VEGFR TKI). The study aims to determine which approach improves overall survival (OS) based on PD-L1 biomarker status. It is a phase III randomized trial enrolling 1250 patients across eight European countries, designed to guide treatment selection using a biomarker-based strategy. The treatments studied include nivolumab and ipilimumab given as intravenous infusions every 21 days in the ICI-ICI group. The ICI-VEGFR TKI group receives pembrolizumab intravenously combined with one of the oral drugs cabozantinib, axitinib, or lenvatinib, taken daily at specified doses. Patients are assigned to treatment arms based on PD-L1 testing results. The trial also involves patient advocacy input and aims to inform clinical guidelines for first-line metastatic RCC therapy. Participants will be monitored throughout the study with evaluations including laboratory tests and performance status assessments. The primary outcome is overall survival measured at the end of the study after 97 months. Additional assessments may include quality of life and patient-reported outcomes. The study requires participants to comply with visits and procedures, and follow-up includes safety and efficacy monitoring to understand the impact of these treatments over time.
CONDITIONS
Official Title
CARE1 Pragmatic Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component
- Intermediate- or poor-risk metastatic RCC as defined by IMDC classification
- Adult male or female patients 18 years of age or older
- Karnofsky Performance Status (KPS) 70% or higher
- Adequate organ and marrow function including neutrophils ≥ 1000/µL, platelets ≥ 100,000/µL, hemoglobin ≥ 8 g/dL, liver enzymes ≤ 5 times upper limit of normal, creatinine clearance ≥ 30 mL/min
- Ability to understand and sign informed consent
- Willingness to comply with study visits and procedures
- Affiliation to a social security system or beneficiary of the same
- Female patients must be non-reproductive or have a negative pregnancy test within 14 days prior to study drug
- Women of childbearing potential must agree to use two forms of contraception during and for 5 months after treatment
- Fertile men with female partners of childbearing potential must agree to use contraception during and for 4 months after treatment
- Female subjects of childbearing potential must not be pregnant at screening
You will not qualify if you...
- Prior systemic anticancer therapy for metastatic RCC except one prior adjuvant therapy if recurrence occurred at least 6 months after last dose
- Uncontrolled brain metastases or neurologic symptoms from CNS metastases
- Use of oral anti-vitamin K anticoagulants unless replaced by LMWH or DOAC considered safe
- Uncontrolled significant illnesses including severe heart failure, unstable angina, recent serious cardiac events, uncontrolled hypertension, recent stroke or thromboembolic events
- Active gastrointestinal bleeding or obstruction
- Clinically significant uncontrolled bleeding
- Autoimmune disease requiring immunosuppressive treatment in past 2 years, including Crohn's disease or ulcerative colitis
- Systemic corticosteroids (>10 mg prednisone daily) or immunosuppressive medication within 14 days before randomization
- Active infection requiring systemic treatment
- Major surgery within 4 weeks before randomization or serious non-healing wounds
- Pregnant or breastfeeding females
- Other active malignancy requiring treatment within 3 years except cured locally curable cancers
- Hypersensitivity to study drugs or excipients
- Use of live vaccines within 28 days before randomization
- Persons deprived of freedom, under guardianship, or unable to comply with medical follow-up for geographic, social, or psychological reasons
AI-Screening
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Trial Site Locations
Total: 46 locations
1
Medical University of Vienna
Vienna, Austria, 1090
Not Yet Recruiting
2
Masarykův onkologický ústav, Masaryk Memorial Cancer Institute (MOU)
Brno, Czechia, 65653
Not Yet Recruiting
3
Fakultní nemocnice Hradec Králová, University Hospital Hradec Kralove (FNHK)
Hradec Králové, Czechia, 50005
Not Yet Recruiting
4
Fakultní nemocnice Olomouc, University Hospital Olomouc (FNOL)
Olomouc, Czechia, 77900
Actively Recruiting
5
Fakultní nemocnice v Motole, University Hospital Motol (MOTOL)
Prague, Czechia, 15000
Not Yet Recruiting
6
Institut de Cancérologie de l'Ouest - Angers
Angers, France, 49055
Actively Recruiting
7
CHU Angers
Angers, France, 49933
Actively Recruiting
8
Institut Sainte Catherine
Avignon, France, 84000
Actively Recruiting
9
CH de la Côte Basque
Bayonne, France, 64100
Actively Recruiting
10
Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
11
CHU de Bordeaux Hôpital Saint-André
Bordeaux, France, 33000
Not Yet Recruiting
12
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
13
CH Châlon Sur Saône
Chalon-sur-Saône, France, 71321
Not Yet Recruiting
14
Centre Jean Perrin
Clermont-Ferrand, France, 63011
Not Yet Recruiting
15
Hôpital Henri Mondor
Créteil, France, 94000
Actively Recruiting
16
Centre Georges-François Leclerc
Dijon, France, 21079
Actively Recruiting
17
CHU Grenoble
Grenoble, France, 38043
Actively Recruiting
18
CHD Vendée
La Roche-sur-Yon, France, 85925
Actively Recruiting
19
Centre Oscar Lambret
Lille, France, 59000
Not Yet Recruiting
20
Polyclinique de Limoges
Limoges, France, 87000
Actively Recruiting
21
Centre Léon Bérard
Lyon, France, 69008
Not Yet Recruiting
22
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
23
Institut Régional du Cancer de Montpellier
Montpellier, France, 34298
Actively Recruiting
24
Centre Antoine Lacassagne
Nice, France, 06189
Actively Recruiting
25
CHU de Nîmes
Nîmes, France, 30029
Actively Recruiting
26
Hôpital de la Pitié Salpêtrière
Paris, France, 75013
Not Yet Recruiting
27
Hôpital Bichat - Claude Bernard
Paris, France, 75018
Not Yet Recruiting
28
Hôpital Tenon
Paris, France, 75020
Actively Recruiting
29
Hôpital Saint-Louis
Paris, France, 75475
Actively Recruiting
30
Institut Mutualiste Montsouris
Paris, France, 75674
Actively Recruiting
31
CH de Pau
Pau, France, 64000
Actively Recruiting
32
Hospices Civils de Lyon
Pierre-Bénite, France, 69310
Actively Recruiting
33
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
34
Institut Godinot
Reims, France, 51100
Actively Recruiting
35
Centre Eugène Marquis
Rennes, France, 35042
Actively Recruiting
36
CHU Saint-Etienne
Saint-Etienne, France, 42270
Not Yet Recruiting
37
Institut de Cancérologie de l'Ouest - Saint Herblain
Saint-Herblain, France, 44806
Actively Recruiting
38
HIA Bégin
Saint-Mandé, France, 94160
Actively Recruiting
39
CHU Sud Réunion
Saint-Pierre, France, 97448
Actively Recruiting
40
Institut de cancérologie Strasbourg Europe
Strasbourg, France, 67200
Actively Recruiting
41
Hôpital Foch
Suresnes, France, 92150
Actively Recruiting
42
Oncopole Claudius Regaud - IUCT-Oncopole
Toulouse, France, 31059
Actively Recruiting
43
Hôpital Bretonneau
Tours, France, 37044
Actively Recruiting
44
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France, 54519
Actively Recruiting
45
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
46
Antoni van Leeuwenhoek
Amsterdam, Netherlands, 1066CX
Not Yet Recruiting
Research Team
L
Laurence ALBIGES, MD, PhD
M
Maia CLAVEAU
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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