WHO ICTRP trial

A study of REGN2810 (Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody)…

EUCTR2017-003684-35-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-003684-35-DE
Public title A study of REGN2810 (Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in patients with lung cancer
Scientific title A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
Primary sponsor Regeneron Pharmaceuticals, Inc.
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries United States;Taiwan;Spain;Austria;United Kingdom;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;Korea, Republic of
Conditions Non-Small Cell Lung Cancer MedDRA version: 20.1 Level: LLT Classification code 10025048 Term: Lung cancer non-small cell recurrent System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04]
Interventions Product Name: cemiplimab Product Code: REGN2810 Pharmaceutical Form: Solution for infusion INN or Proposed INN: cemiplimab Current Sponsor code: REGN2810 Other descriptive name: HUMAN IGG4 ISOTYPE MONOCLONAL (GDF8) ANTIBODY Concentration…
Registration date Apr 4, 2018
Target size 201
Secondary IDs R2810-ONC-1763
Registry page clinicaltrialsregister.eu

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