CARE1 Pragmatic Clinical Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,250

Participants

Timeline

Start Date

April 12, 2024

Primary Completion Date

May 5, 2032

Study Completion Date

May 5, 2032

Conditions
Metastatic Kidney CancerMetastatic Kidney Carcinoma
Interventions
DRUG

Nivolumab

Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion. Nivolumab is to be administered first. The nivolumab infusion must be promptly followed by a saline flush to clear the line of nivolumab before starting the ipilimumab infusion.

DRUG

Ipilimumab

"The second infusion will always be ipilimumab and will start at least 30 minutes after completion of the nivolumab infusion. Ipilimumab is to be administered as an approximately 30-minute IV infusion.~When administered together, nivolumab and ipilimumab will be administered on Day 1 of each 21-day cycle."

DRUG

Pembrolizumab

Pembrolizumab is to be administered as an approximately 30-minute IV infusion.

DRUG

Cabozantinib

Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.

DRUG

Axitinib

Axitinib is a medication that is taken orally every day, 2 times a day continuously, at the starting dose of 5mg x2/day.

DRUG

Lenvatinib

Lenvatinib is a medication that is taken orally every day, once a day at the initial dose of 20mg/day.

Trial Locations (46)

1090

NOT_YET_RECRUITING

Medical University of Vienna, Vienna

13009

RECRUITING

Institut Paoli-Calmettes, Marseille

14076

RECRUITING

Centre François Baclesse, Caen

15000

NOT_YET_RECRUITING

Fakultní nemocnice v Motole, University Hospital Motol (MOTOL), Prague

21079

RECRUITING

Centre Georges-François Leclerc, Dijon

25030

RECRUITING

Hôpital Jean Minjoz, Besançon

30029

RECRUITING

CHU de Nîmes, Nîmes

31059

RECRUITING

Oncopole Claudius Regaud - IUCT-Oncopole, Toulouse

33000

NOT_YET_RECRUITING

CHU de Bordeaux Hôpital Saint-André, Bordeaux

34298

RECRUITING

Institut Régional du Cancer de Montpellier, Montpellier

35042

RECRUITING

Centre Eugène Marquis, Rennes

37044

RECRUITING

Hôpital Bretonneau, Tours

38043

RECRUITING

CHU Grenoble, Grenoble

42270

NOT_YET_RECRUITING

CHU Saint-Etienne, Saint-Etienne

44806

RECRUITING

Institut de Cancérologie de l'Ouest - Saint Herblain, Saint-Herblain

49055

RECRUITING

Institut de Cancérologie de l'Ouest - Angers, Angers

49933

RECRUITING

CHU Angers, Angers

50005

NOT_YET_RECRUITING

Fakultní nemocnice Hradec Králová, University Hospital Hradec Kralove (FNHK), Hradec Králové

51100

RECRUITING

Institut Godinot, Reims

54519

RECRUITING

Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy

59000

NOT_YET_RECRUITING

Centre Oscar Lambret, Lille

63011

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

64000

RECRUITING

CH de Pau, Pau

64100

RECRUITING

CH de la Côte Basque, Bayonne

65653

NOT_YET_RECRUITING

Masarykův onkologický ústav, Masaryk Memorial Cancer Institute (MOU), Brno

67200

RECRUITING

Institut de cancérologie Strasbourg Europe, Strasbourg

69008

NOT_YET_RECRUITING

Centre Léon Bérard, Lyon

69310

RECRUITING

Hospices Civils de Lyon, Pierre-Bénite

71321

NOT_YET_RECRUITING

CH Châlon Sur Saône, Chalon-sur-Saône

75013

NOT_YET_RECRUITING

Hôpital de la Pitié Salpêtrière, Paris

75018

NOT_YET_RECRUITING

Hôpital Bichat - Claude Bernard, Paris

75020

RECRUITING

Hôpital Tenon, Paris

75475

RECRUITING

Hôpital Saint-Louis, Paris

75674

RECRUITING

Institut Mutualiste Montsouris, Paris

77900

RECRUITING

Fakultní nemocnice Olomouc, University Hospital Olomouc (FNOL), Olomouc

84000

RECRUITING

Institut Sainte Catherine, Avignon

85925

RECRUITING

CHD Vendée, La Roche-sur-Yon

86021

RECRUITING

CHU Poitiers, Poitiers

87000

RECRUITING

Polyclinique de Limoges, Limoges

92150

RECRUITING

Hôpital Foch, Suresnes

94000

RECRUITING

Hôpital Henri Mondor, Créteil

94160

RECRUITING

HIA Bégin, Saint-Mandé

94805

RECRUITING

Gustave Roussy, Villejuif

97448

RECRUITING

CHU Sud Réunion, Saint-Pierre

06189

RECRUITING

Centre Antoine Lacassagne, Nice

1066CX

NOT_YET_RECRUITING

Antoni van Leeuwenhoek, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

European Commission

OTHER

collaborator

CRIS Cancer Foundation

UNKNOWN

collaborator

National Cancer Institute, France

OTHER_GOV

collaborator

Rennes University Hospital

OTHER

collaborator

University Hospital, Essen

OTHER

collaborator

Fundació Privada Institut d'Investigació Oncològica de Vall d'Hebron

UNKNOWN

collaborator

The Netherlands Cancer Institute

OTHER

collaborator

Servicio Madrileño de Salud, Madrid, Spain

OTHER

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

collaborator

Medical University of Vienna

OTHER

collaborator

FAKULTNI NEMOCNICE OLOMOUC

UNKNOWN

collaborator

International Kidney Cancer Coalition

UNKNOWN

collaborator

Association pour la Recherche sur les Tumeurs du Rein

UNKNOWN

collaborator

Resilience

INDUSTRY

collaborator

PRIMAA

UNKNOWN

collaborator

Queen Mary University of London

OTHER

lead

Gustave Roussy, Cancer Campus, Grand Paris

OTHER