WHO ICTRP trial

A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in…

NL-OMON49041 · Overview of Medical Research in the Netherlands (NL-OMON) · Recruiting

Key facts

Trial ID NL-OMON49041
Public title A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Scientific title A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination with Nivolumab and Ipilimumab versus Nivolumab and Ipilimumab in Subjects with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk - COSMIC-313
Primary sponsor Exelixis Inc.
Registry Overview of Medical Research in the Netherlands (NL-OMON)
Recruitment status Recruiting
Study type Interventional
Phase 3
Countries Argentina;Australia;Austria;Brazil;Canada;Chile;Czechia;Finland;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea (the Republic of);Mexico;Netherlands;New Zealand;Poland;Singapore;Spain;Taiwan…
Conditions Hypernephroma Renal Cell Cancer;10038364;Hypernephroma;Renal Cell Cancer
Interventions Subjects who meet all study eligibility criteria will be randomly assigned in a 1:1 fashion to receive double-blinded study treatment as follows: Experimental arm: Cabozantinib (40 mg oral, once daily [qd]) + nivolumab (3 mg/kg infusion…
Registration date Mar 16, 2021
Target size 15
Secondary IDs 2018-004567-31;NL70854.018.19
Registry page onderzoekmetmensen.nl

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