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A 3-Arm, Randomized, Blinded, Active-Controlled, Phase II Study of RO7121661, a PD1-TIM3 Bispecific Antibody and RO7247669, a PD1-LAG3 Bispecific Antibody, Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of lomvastomig and tobemstomig, compared with nivolumab, in patients with advanced or metastatic esophageal squamous-cell carcinoma (ESCC) refractory or intolerant to fluoropyrimidine- or taxane- and platinum-based regimen. Following approval of the protocol amendment version 3, recruitment into the lomvastomig arm has been stopped. The decision to stop recruitment for lomvastomig was based on strategic considerations and not based on emerging safety and/or efficacy data. The benefit/risk assessment for lomvastomig remains unchanged. The study was planned to enroll participants randomized in a 1:1:1 ratio to receive lomvastomig, tobemstomig, or nivolumab. With version 3 of the protocol, recruitment into the lomvastomig arm has stopped, and moving forward, participants will be randomized in a 1:1 ratio to receive either tobemstomig or nivolumab.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Inst. Alexander Fleming
Buenos Aires, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, Argentina
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil
Masaryk?v onkologický ústav
Brno, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Rigshospitalet
København Ø, Denmark
Odense Universitetshospital, Onkologisk Afdeling R
Odense C, Denmark
Institut Bergonie
Bordeaux, France
Hopital Claude Huriez
Lille, France
Start Date
June 25, 2021
Primary Completion Date
January 30, 2025
Completion Date
January 30, 2025
Last Updated
March 5, 2025
206
ACTUAL participants
Lomvastomig
DRUG
Tobemstomig
DRUG
Nivolumab
DRUG
Lead Sponsor
Hoffmann-La Roche
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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