AzTrials
AzTrials

Metastatic Kidney CancerPhase 3CARE1NCT06364631

CARE1 Pragmatic Clinical Trial

A Phase 3 study testing Nivolumab, Ipilimumab and Pembrolizumab in people with Metastatic Kidney Cancer and Metastatic Kidney Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 46 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Ipilimumab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,250 participants
Where
46 sitesin 4 countries
Study dates
12 Apr 2024to 5 May 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed metastatic (AJCC Stage IV) renal cell carcinoma with a clear-cell component.
  • Intermediate- or poor-risk mRCC as defined by IMDC classification.
  • Adult male or female patients (≥ 18 years of age at inclusion).
  • Karnofsky Performance Status (KPS) ≥70%.
  • Adequate organ and marrow function, according to investigator assessment and
  • Absolute neutrophil count (ANC) ≥ 1000/μL (≥ 1.5 GI/L)
Show all 16Show fewer
  • Platelets ≥ 100,000/μL (≥ 100 GI/L)
  • Hemoglobin ≥ 8 g/dL (≥ 80 g/L)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
  • Calculated creatinine clearance ≥ 30 mL/min (≥ 0.67 mL/sec) using the CKD- EPI equation
  • Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed.
  • Patient should be able and willing to comply with study visits and procedures as per protocol
  • Patients must be affiliated to a social security system or beneficiary of the same
  • Female patients must either be of non-reproductive potential or must have a negative serum pregnancy test within 14 days prior to the administration of study drug. Childbearing potential women must have agreed to use one barrier method of contraception, such as condom, plus an additional highly effective method of contraception during treatment on this trial and for up to 5 months after the last dose of study treatment.
  • Fertile men with a female partner of childbearing potential must agree to use one barrier method of contraception, such as condom, during treatment on this trial and for up to 4 months after the last dose of treatment. Their women of childbearing potential partner must agree to use a highly effective method of contraception during the same period.
  • Female subjects of childbearing potential must not be pregnant at screening.

Who cannot join

  • Prior systemic anticancer therapy for mRCC including investigational agents. Note: One prior systemic adjuvant therapy is allowed for completely resected RCC and if recurrence occurred at least 6 months after the last dose of adjuvant therapy.
  • Uncontrolled brain metastases (adequately treated with radiotherapy and/or radiosurgery prior to randomization are eligible). Subjects who are neurologically symptomatic as a result of their CNS metastasis or are receiving systemic corticosteroid treatment (prednisone equivalent > 10 mg/day) at the planned time of randomization are not eligible.
  • Concomitant oral anti-vitamin K anticoagulation. An exception is the use of LMWH or direct oral anticoagulants (DOAC), if considered safe by investigator assessment.
  • The subject has uncontrolled, significant intercurrent or recent illness such as the following conditions:
  • Cardiovascular disorders:
  • Congestive heart failure (CHF) class III or IV as defined by the New York Heart Association, unstable angina pectoris, myocardial infarction, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes).
Show all 21Show fewer
  • Uncontrolled hypertension despite optimal antihypertensive treatment.
  • Stroke, or other symptomatic ischemic event or severe thromboembolic event (e.g., symptomatic pulmonary embolism [PE], incidental PE is acceptable if deemed safe by the investigator) within 3 months before randomization.
  • Active GI bleeding or symptomatic Gastrointestinal (GI) tract obstruction
  • Clinically significant bleeding including uncontrolled hematuria, hematemesis, or hemoptysis
  • Autoimmune disease that has been symptomatic or required immunosuppressive systemic treatment within the past two years from the date of randomization.
  • Note: Patients with a history of Crohn's disease or ulcerative colitis are always excluded
  • Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization.
  • Note: Inhaled, intranasal, intra-articular, or topical steroids are permitted. Adrenal replacement steroid doses > 10 mg daily prednisone equivalent are permitted. Transient short-term use of systemic corticosteroids for allergic conditions (e.g., contrast allergy) is also allowed.
  • Active infection requiring systemic treatment.
  • Major surgery (e.g., nephrectomy, GI surgery, removal of brain metastasis) within 4 weeks prior to randomization or serious non-healing wound/ulcer/bone fracture.
  • Pregnant or breastfeeding females.
  • Any other active malignancy at time of randomization or diagnosis of another malignancy within 3 years prior to randomization that requires active treatment, except for locally curable cancers that have been apparently cured.
  • Hypersensitivity to any of the active substances or to any of the excipients administered during the study
  • Use of live vaccines within 28 days before randomization
  • 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, social or psychological reasons.

Trial locations and contacts

46 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Laurence ALBIGES, MD, PhD contact

+33 (0)1 42 11 66 90

laurence.albiges@gustaveroussy.fr

Maia CLAVEAU contact

+33 (0)1 42 11 53 49

Maia.CLAVEAU@gustaveroussy.fr

46 sites in 4 countries

France40 sites, 40 recruiting

  • Institut de Cancérologie de l'Ouest - Angers

    Angers, 49055

    Elouen BOUGHALEM, MD, +33241352700, elouen.boughalem@ico.unicancer.fr

    Recruiting

  • CHU Angers

    Angers, 49933

    Pierre BIGOT, MD, PhD, +33 241356196, pibigot@chu-angers.fr

    Recruiting

  • Institut Sainte Catherine

    Avignon, 84000

    Bertrand BILLEMONT, MD, +33 490276231, b.billemont@isc84.org

    Recruiting

  • CH de la Côte Basque

    Bayonne, 64100

    Louis FRANCOIS, MD, +33 559443535, lfrancois@ch-cotebasque.fr

    Recruiting

  • Hôpital Jean Minjoz

    Besançon, 25030

    Fabien CALCAGNO, MD, +33 370632403, fabien.calcagno@gmail.com

    Recruiting

  • CHU de Bordeaux Hôpital Saint-André

    Bordeaux, 33000

    Felix LEFORT, MD, +33 556795808, felix.lefort@chu-bordeaux.fr

    Not yet recruiting

  • Centre François Baclesse

    Caen, 14076

    Florence JOLY, MD, PhD, +33 231455002, f.joly@baclesse.unicancer.fr

    Recruiting

  • CH Châlon Sur Saône

    Chalon-sur-Saône, 71321

    Axelle BOUDRANT, MD, +33 385910045, axelle.boudrant@ch-chalon71.fr

    Not yet recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Hakim MAHAMMEDI, MD, +33 473278080, hakim.mahammedi@clermont.unicancer.fr

    Not yet recruiting

  • Hôpital Henri Mondor

    Créteil, 94000

    Christophe TOURNIGAND, MD, PhD, +33 149812567, christophe.tournigand@aphp.fr

    Recruiting

  • Centre Georges-François Leclerc

    Dijon, 21079

    Sylvain LADOIRE, MD, PhD, +33 380737506, sladoire@cgfl.fr

    Recruiting

  • CHU Grenoble

    Grenoble, 38043

    Mathieu LARAMAS, MD, +33476765451, mlaramas@chu-grenoble.fr

    Recruiting

  • CHD Vendée

    La Roche-sur-Yon, 85925

    Charlotte GREILSAMER, MD, +33 251446173, charlotte.greilsamer@ght85.fr

    Recruiting

  • Centre Oscar Lambret

    Lille, 59000

    Diane PANNIER, MD, +33 320295959, d-pannier@o-lambret.fr

    Not yet recruiting

  • Polyclinique de Limoges

    Limoges, 87000

    Sabrina FALKOWSKI, MD, +33 555454800, sf@imagerned-87.com

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Armelle VINCENEUX, MD, +33 426556833, armelle.vinceneux@lyon.unicancer.fr

    Not yet recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Gwenaelle GRAVIS, MD, +33 491223740, gravisg@ipc.unicancer.fr

    Recruiting

  • Institut Régional du Cancer de Montpellier

    Montpellier, 34298

    Diego TOSI, MD, PhD, +33 467612304, diego.tosi@icm.unicancer.fr

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Delphine BORCHIELLINI, MD, +33 4 92 03 15 14, Delphine.borchiellini@nice.unicancer.fr

    Recruiting

  • CHU de Nîmes

    Nîmes, 30029

    Nadine HOUEDE, MD, PhD, +33 466683231, nadine.houede@chu-nimes.fr

    Recruiting

  • Hôpital de la Pitié Salpêtrière

    Paris, 75013

    Loïc JAFFRELOT, MD, +33 142160507, loic.jaffrelot@aphp.fr

    Not yet recruiting

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

    Idir OUZAID, MD, PhD, +33 140258935, idir.ouzaid@aphp.fr

    Not yet recruiting

  • Hôpital Tenon

    Paris, 75020

    Ahmed KHALIL, MD, +33 611174284, ahmed.khalil@aphp.fr

    Recruiting

  • Hôpital Saint-Louis

    Paris, 75475

    Clément DUMONT, MD, +33142494217, clement.dumont@aphp.fr

    Recruiting

  • Institut Mutualiste Montsouris

    Paris, 75674

    Mostefa BENNAMOUN, md, +33 156616241, mostefa.bennamoun@imm.fr

    Recruiting

  • CH de Pau

    Pau, 64000

    Kévin BOURCIER, MD, +33 559727608, kevin.bourcier@ch-pau.fr

    Recruiting

  • Hospices Civils de Lyon

    Pierre-Bénite, 69310

    Denis MAILLET, MD, +33478861771, denis.maillet@chu-lyon.fr

    Recruiting

  • CHU Poitiers

    Poitiers, 86021

    Sheik EMAMBUX, MD, +33 549444279, sheik.emambux@chu-poitiers.fr

    Recruiting

  • Institut Godinot

    Reims, 51100

    Jean-Christophe EYMARD, MD, +33 326504382, jeanchristophe.eymard@reims.unicancer.fr

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35042

    Brigitte LAGUERRE, MD, +33299253182, b.laguerre@rennes.unicancer.fr

    Recruiting

  • CHU Saint-Etienne

    Saint-Etienne, 42270

    Denis MAILLET, MD, +33 4 78 86 17 71, denis.maillet@chu-lyon.fr

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest - Saint Herblain

    Saint-Herblain, 44806

    Frédéric ROLLAND, MD, +33 (0)2 40 67 99 00, frederic.rolland@ico.unicancer.fr

    Recruiting

  • HIA Bégin

    Saint-Mandé, 94160

    Carole HELISSEY, MD, +33143985319, carole.helissey@gmail.com

    Recruiting

  • CHU Sud Réunion

    Saint-Pierre, 97448

    Mohamed KHETTAB, MD, +262 262359000, mohamed.khettab@chu-reunion.fr

    Recruiting

  • Institut de cancérologie Strasbourg Europe

    Strasbourg, 67200

    Philippe BARTHELEMY, MD, +33 368766767, p.barthelemy@icans.eu

    Recruiting

  • Hôpital Foch

    Suresnes, 92150

    Raffaele RATTA, MD, +33 146253581, r.ratta@hopital-foch.com

    Recruiting

  • Oncopole Claudius Regaud - IUCT-Oncopole

    Toulouse, 31059

    Damien POUESSEL, MD, PhD, +33 531155993, pouessel.damien@iuct-oncopole.fr

    Recruiting

  • Hôpital Bretonneau

    Tours, 37044

    Mathilde CANCEL, MD, +33 247479919, m.cancel@chu-tours.fr

    Recruiting

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Lionel GEOFFROIS, MD, +33 3 83 59 84 61, l.geoffrois@nancy.unicancer.fr

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Laurence ALBIGES, MD, PhD, +33 (0)1 42 11 66 90, laurence.albiges@gustaveroussy.fr

    Recruiting

Other trials in France

Czechia4 sites, 4 recruiting

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

    Brno, 65653

    Alexandr Poprach, MD, PhD, +420 543136831, poprach@mou.cz

    Not yet recruiting

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

    Hradec Králové, 50005

    Jindřich Kopecký, MD, PhD, +420 495834980, jindrich.kopecky@fnhj.cz

    Not yet recruiting

  • Fakultní nemocnice Olomouc, University Hospital Olomouc (FNOL)

    Olomouc, 77900

    Hana Študentová, MD, +420 588 441 111, hana.studentova@fnol.cz

    Recruiting

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

    Prague, 15000

    Tomáš Büchler, MD, PhD, +420 224439427, tomas.buchler@fnmotol.cz

    Not yet recruiting

Other trials in Czechia

Austria1 site, 1 recruiting

  • Medical University of Vienna

    Vienna, 1090

    Manuela Schmidinger, MD, +43 69910710844, manuela.schimidinger@meduniwien.ac.at

    Not yet recruiting

Other trials in Austria

Netherlands1 site, 1 recruiting

  • Antoni van Leeuwenhoek

    Amsterdam, 1066CX

    Sofie Wilgenhof, MD, +31 020 512 9111, s.wilgenhof@nki.nl

    Not yet recruiting

Other trials in Netherlands

About this study

Official title: First Line Randomised Study Platform to Optimize Treatment in Patients With Metastatic Renal Cell Carcinoma

Systemic therapy for renal cell carcinoma (RCC) relies on 2 classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD1/PDL1 axis or CTLA4. Combination therapy is SOC for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the 2 approaches and patients are treated based on physician decision without clinical /biomarker factors to guide treatment selection. PDL1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PDL1(+) and ICI-VEGFR TKI in PDL1(-) patients.

Study design has been developed to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging Overall Survival (OS) for PDL1(+) patients and to demonstrate that ICI-VEGFR TKI is superior to ICI-ICI in prolonging Progression Free Survival (PFS) and OS for PDL1(-) patients.

Read the detailed description

In 2020, there were an estimated 431 288 new cases of kidney cancer (Renal Cell Carcinoma, RCC) globally with 138 611 cases in Europe, leading to 179 368 deaths worldwide, including 54 054 deaths in Europe (source: IARC/Globocan). To define high priority topics in academic research and launch dedicated trials, European RCC academic physicians have gathered into a European initiative - the CARE group.

Systemic therapy for RCC relies on two classes of agents: anti-angiogenic targeted therapy (Vascular endothelial growth factor Tyrosine Kinase Inhibitor- VEGFR TKI) and immune checkpoint inhibitor (ICI), targeting either PD-1/PD-L1 axis or CTLA-4. Combination therapy is standard of care (SOC) for clear cell RCC in all guidelines with either ICI-ICI or ICI-VEGFR TKI. However, no head-to-head comparison have been performed between the two approaches and patients are treated based on physician decision without clinical or biomarker factors to guide treatment selection. PD-L1 staining is, to date, the biomarker that has demonstrated its ability to enrich for overall survival benefit favoring ICI-ICI strategy in PD-L1(+) and ICI-VEGFR TKI in PD-L1(-) patients.

CARE1 PCT is a prospective randomize phase III study, in first line setting for patients with metastatic clear cell RCC comparing ICI-ICI vs ICI-VEGFR TKI approaches stratified on PD-L1 by local determination. Primary endpoint is overall survival (OS). The trial will enroll 1250 patients over 4 years across eight European countries (France, Spain, Netherlands, Czech Republic, Austria, Germany, Italy, UK) that are part of the CARE consortium. Study Sponsor is Gustave Roussy institute within the GETUG network for France, co-sponsor is developed through main academic networks (eg. SOGUG in Spain) and main institutions across Europe (eg. Cancer Core Europe - CCE). Study design has been develop to demonstrate that ICI-ICI is superior to ICI-VEGFR TKI in prolonging OS for PD-L1(+) patients and that ICI-VEGFR TKI is superior to ICI-ICI in prolonging OS for PD-L1(-) patients. CARE1 PCT has been designed and will be conducted with patient advocacy group representatives (ARTuR and IKCC) input.

CARE1 is an academic phase III study designed to define the optimal combination using a pragmatic routinely implementable biomarker. Therefore, CARE1 will inform practice and has the potential to change treatment guidelines. Taken all together, CARE1 is a unique opportunity to build a large-scale platform to define new biomarker based therapy guidelines as well as to investigate quality of life, patient reported outcome and Health-Economic in front line setting, as well as pathological and blood biobank collection for further translational work. This action is part of the Cancer Mission cluster of projects on 'Diagnosis and treatment'.

Keywords
METASTATIC KIDNEY CANCER, METASTATIC KIDNEY CARCINOMA, PRAGMATIC CLINICAL TRIAL, PDL1
Medical subject headings
Kidney Neoplasms, Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabDrug

    Also called OPDIVO

    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.

  • IpilimumabDrug

    Also called YERVOY

    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.

  • PembrolizumabDrug

    Also called KEYTRUDA

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

  • CabozantinibDrug

    Also called CABOMETYX

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

  • AxitinibDrug

    Also called INLYTA

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

  • LenvatinibDrug

    Also called LENVIMA

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

Study groups in NCT06364631
Study groupRoleWhat they receive
Arm A: ICI - ICI CombinationOtherNivolumab (3 mg/kg infusion, every 3 weeks) x 4 doses + ipilimumab (1 mg/kg infusion, every 3 weeks) x 4 doses. At the end of the 4 injections carried out 21 days apart and in the absence of limiting side effects or progression justifying the cessation of the treatment according to the investigating doctor, maintenance treatment with nivolumab will be continued, at a rate of one injection every 2 weeks at a dose of 240 mg or every 4 weeks at a dose of 480 mg depending on the choice of the investigating doctor. Nivolumab will be administered for a maximum of 2 years. Patients are required to receive all four doses of NIVO+IPI before beginning NIVO monotherapy except for ipilimumab-induced toxicity compatible with nivolumab maintenance.
Receives: Drug: Nivolumab; Drug: Ipilimumab
Arm B: VEGFR-TKI- ICI arm (axitinib + pembrolizumab)OtherInvestigator's choice between: * Axitinib (5 mg oral twice a day) + pembrolizumab (200 mg flat IV every 3 weeks or 400 mg flat IV every 6 weeks). * Cabozantinib (40 mg oral, once a day away from meals) + nivolumab infusion (480 mg flat dose every 4 weeks) * Lenvatinib (20 mg oral, once a day) + pembrolizumab (200 mg flat IV every 3 weeks or 400 mg flat IV every 6 weeks)
Receives: Drug: Nivolumab; Drug: Pembrolizumab; Drug: Cabozantinib; Drug: Axitinib; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS).

    From randomization to time of death

    Measured: At end of study, 97 months

Secondary outcomes (12)

  1. Progression-free survival according to RECIST 1.1

    From randomization to progression, also a primary outcome for PDL1(-) population.

    Measured: At end of study, 97 months

  2. Objective Response Rate (ORR) according to RECIST 1.1

    ORR (estimand 3) is defined as the percentage of randomised participants (ITT set) who achieve a best response of complete response (CR) or partial response (PR) over the treatment observation period based on Investigators assessments.

    Measured: At end of treatment, 60 months

  3. Quality of Life via questionnaire EQ-5D-5L

    Patient's response to the Quality of Life questionnaire EQ-5D-5L.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  4. Quality of Life via questionnaire NNCCN/FACT Kidney Cancer Symptom Index (NFKSI)

    Patient's response to the Quality of Life questionnaire NFKSI19.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  5. Quality of Life via questionnaire Kidney Symptom Index (KSI)

    Patient's response to the Quality of Life questionnaire KSI.

    Measured: Baseline, Month 3, Month 6, Month 9, Month 12

  6. Duration of Treatment

    Duration of protocolar treatment administration.

    Measured: At end of treatment, 60 months

  7. Time to treatment discontinuation (TTD)

    TTD is defined as the time from the date of treatment initiation to the date of last treatment dose.

    Measured: At end of treatment, 60 months

  8. Treatment-free survival (TFS)

    TFS is defined as the date from protocol therapy cessation (whatever the reason) to the date of subsequent systemic therapy initiation or death.

    Measured: At end of study, 97 months

  9. Time to subsequent systemic anticancer therapy (TTSST)

    TTSST is defined the time from the date of randomization to the date of next subsequent systemic therapy.

    Measured: At end of study, 97 months

  10. Incidence of AE's

    Incidence of AEs will be summarized by system organ class and preferred term according to MedDRA coding, and will be presented by treatment groups and overall.

    Measured: At end of treatment, 60 months

  11. Health Economic evaluation: healthcare costs [France & Netherlands only]

    The cost difference between arms in each patient subgroup (comparison of healthcare costs)

    Measured: At end of study, 97 months

  12. Health Economic evaluation: cost-utility [France & Netherlands only]

    The incremental cost per QALY and the incremental net monetary benefit in each patient subgroup (cost-utility analysis).

    Measured: At end of study, 97 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2024
  2. Study start12 Apr 2024
  3. Primary completion5 May 2032 (estimated)
  4. Study completion5 May 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
International, multicenter, open-label, randomized, controlled Phase 3 trial - 2 arms (A and B)
Masking
None (open label)
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06364631
Sponsor's protocol ID
2023-503317-29-00
Other IDs
2023/3764, 2023
Acronym
CARE1
Status last verified
Jan 2025
First submitted
4 Apr 2024
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nivolumab, Ipilimumab and Pembrolizumab in people with Metastatic Kidney Cancer and Metastatic Kidney Carcinoma, run by Gustave Roussy, Cancer Campus, Grand Paris at 46 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in France, Czechia, Austria, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laurence ALBIGES, MD, PhD (+33 (0)1 42 11 66 90, laurence.albiges@gustaveroussy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS). (time frame: At end of study, 97 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06364631.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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