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

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