This website uses cookies to improve and personalize content and for tracking and analytics. This site only collects necessary cookies. You can read the cookie policy by clicking here or learn more from our Privacy Statement.
Phase 3 Study of Cabozantinib with Nivolumab and Ipilimumab vs Nivolumab and Ipilimumab Alone in Advanced Treatment-Naive Renal Cell Carcinoma


Phase 3 Study of Cabozantinib with Nivolumab and Ipilimumab vs Nivolumab and Ipilimumab Alone in Advanced Treatment-Naive Renal Cell Carcinoma

USES DESCRIBED HERE ARE INVESTIGATIONAL; SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED

THIS TRIAL IS NO LONGER RECRUITING PATIENTS

Study Overview

Randomization to either cabozantinib in combination with Nivolumab and ipilimumab or nivolumab and ipilimumab alone for renal cell carcinoma

Stratification

Divider Line
  • IMDC prognostic score (intermediate vs poor)
  • Region (US, Canada, Europe, Australia, or New Zealand vs South America or Asia)

Key Eligibility Criteria

  • Advanced or metastatic RCC with a clear-cell component (including sarcomatoid)
  • Intermediate- or poor-risk RCC as defined by IMDC
  • Measurable disease
  • Shipment of archival or fresh tumor tissue sample prior to randomization
  • KPS ≥70%
  • No prior systemic therapy for unresectable locally advanced or metastatic RCC
    • One prior adjuvant therapy, excluding a combination of a PD-(L)1 inhibitor with a CTLA-4 inhibitor, allowed if disease recurrence ≥6 months after last dose

Key Endpoints

Primary Endpoint

  • PFS by BIRC

Secondary Endpoint

  • OS

Additional Endpoints

  • ORR by BIRC
  • PFS and ORR by BIRC according to PD-L1 status
  • PFS and ORR by investigator
  • Duration of objective tumor response by BIRC and investigator
  • Analysis of biomarkers and clinical outcomes
  • HRQoL per EQ-5D-5L

Trial Sites

COSMIC-313 will be conducted in the United States and abroad. For specific location and site information, and to confirm whether sites near you are still enrolling new patients, call 1-888-393-5494 (toll-free) or 1-303-389-1847.

      • La Jolla
      • Orange
    • Washington DC
      • Boca Raton
      • Miami
      • Atlanta
      • Chicago
      • Overland Park
      • Boston
      • Burlington
      • Baltimore
      • Scarborough
      • Detroit
      • St. Louis
      • Charlotte
      • Omaha
      • Syracuse
      • Portland
      • Pittsburgh
      • Charleston
      • Myrtle Beach
      • Nashville
      • Fairfax
      • Spokane
      • Seattle
      • Madison
    • Buenos Aires
    • Pilar
    • Ciudad de Buenos Aires
    • San Miguel de Tucuman
    • CABA
    • Cordoba
    • Rosario
    • Box Hill
    • Adelaide
    • Chermside
    • Port Macquarie
    • Chermside
    • WA
      • South Brisbane
      • Elizabeth Vale
    • Ballarat
    • St. Leonards
    • WA
    • Woolloongabba
      • Albury
      • Randwick
      • Kogarah
      • Darlinghurst
      • Macquarie University
    • Wiener Neustadt
    • Salzburg
    • Wien
    • Hasselt
    • Barretos
    • Curitiba
    • Sao Jose do Rio Preto
    • Belo Horizonte - Minas Gerais
    • São Paulo
    • Porto Alegre
      • Calgary
      • Ottawa
      • Toronto
      • Montreal
    • Temuco
    • Recoleta
    • Santiago
    • Praha 5
    • Kralove
    • Prague
    • Praha 4
    • Tampere
    • Turku
    • Helsinki
    • Toulouse Cedex
    • Le Mans
    • Besancon Cedex
    • Villejuif
    • Nice
    • Bordeaux
    • Rennes
    • Reims Cedex
    • Lyon
    • Montpellier
    • Nice cedex 2
    • Paris
    • Vandoeuvre les Nancy
    • Strasbourg
    • Nuernberg
    • Frankfurt am Main
    • Munster
    • Heidelberg
    • Dresden
    • Tuebingen
    • Mainz
    • Jena
    • Tuen Muen
    • Hong Kong
    • Shatin
    • Pecs
    • Budapest
    • Kfar Saba
    • Tel Hashomer
    • Haifa
    • Petah Tikva
    • Beer Sheva
    • Jerusalem
    • Meldola
    • Candiolo
    • Arezzo
    • Modena
    • Faenza
    • Ravenna
    • Terni
    • Padova
    • Perugia
    • Pavia
    • Rimini
    • Benito Juarez
    • Queretaro
    • Monterrey
    • Leon, Guanajuato
    • Aguascalientes
    • Oaxaca
    • Jalisco
    • Amsterdam
    • Rotterdam
    • Hamilton
    • Christchurch
    • Newtown
    • Bydgoszcz
    • Biala Podlaska
    • Gdansk
    • Otwock
    • Poznan
    • Singapore
    • Gyeonggi-do
    • Gyeongsangnam-do
    • Seoul
    • Asturias
    • Barcelona
    • Córdoba
    • Madrid
    • Oviedo
    • Pamplona
    • Santiago de Compostela
    • Valencia
    • Kaohsiung
    • Taichung
    • Taipei
    • Taoyuan City
    • London
    • Manchester
    • Sketty, Swansea
    • Glasgow

Trial sites may be added, or may stop enrolling patients, at any time. Please check back if you do not see a trial site located near you.

Learn more about this trial at www.clinicaltrials.gov and search for NCT03937219, or contact Exelixis Medical Information at 1-888-EXELIXIS (1-888-393-5494) toll free, or 1-303-389-1847.

The combination of cabozantinib with nivolumab and ipilimumab is not approved for the use under investigation

BIRC, blinded independent radiology committee; HRQoL, health-related quality of life; IMDC, International Metastatic RCC Database Consortium; IV, intravenous; KPS, Karnofsky performance status; ORR, objective response rate; OS, overall survival; PD-(L)1, programmed death receptor-1 or programmed death receptor-1 ligand; PD-L1, programmed death receptor-1 ligand; PFS, progression-free survival; qd, once daily; q3w, every 3 weeks; q4w, every 4 weeks; RCC, renal cell carcinoma