Spots Global Cancer Trial Database for A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
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Trial Identification
Brief Title: A Study of Lomvastomig (RO7121661) and Tobemstomig (RO7247669) Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus
Official Title: 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
Study ID: NCT04785820
Study Description
Brief Summary: 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Inst. Alexander Fleming; Oncologia, Buenos Aires, , Argentina
Centro Oncologico Riojano Integral (CORI), La Rioja, , Argentina
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP, Sao Paulo, SP, Brazil
Hospital Sírio-Libanês, Sao Paulo, SP, Brazil
Beneficencia Portuguesa de Sao Paulo, São Paulo, SP, Brazil
Masaryk?v onkologický ústav; Klinika komplexní onkologické pé?e, Brno, , Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika, Olomouc, , Czechia
Rigshospitalet; Onkologisk Klinik, København Ø, , Denmark
Odense Universitetshospital, Onkologisk Afdeling R, Odense C, , Denmark
Institut Bergonie; Oncologie, Bordeaux, , France
Hopital Claude Huriez; Medecine Interne Oncologie, Lille, , France
CENTRE LEON BERARD; Département d?Hématologie et d?Oncologie, Lyon, , France
Hopital Timone Adultes; Oncologie Digestive, Marseille, , France
Institut régional du Cancer Montpellier, Montpellier, , France
APHP - Hopital Saint Antoine, Paris, , France
ICO Rene Gauducheau; CEC, St Herblain, , France
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont, Szolnok, , Hungary
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS, Meldola, Emilia-Romagna, Italy
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della, Udine, Friuli-Venezia Giulia, Italy
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda, Padova, Veneto, Italy
International Cancer Institute (ICI), Eldoret, , Kenya
Aga Khan University Hospital, Nairobi, , Kenya
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Guro Hospital, Seoul, , Korea, Republic of
Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny, Brzozów, , Poland
Centrum Onkologii w Bydgoszczy, Bydgoszcz, , Poland
Szpital Morski im. PCK; Poradnia Onkologiczna, Gdynia, , Poland
Krakowski Szpital Specjalistyczny im sw. Jana Paw?a II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol., Kraków, , Poland
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii, Warszawa, , Poland
Bashkirian Republican Clinical Oncology Dispensary, UFA, Baskortostan, Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov, Moscow, Moskovskaja Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy, Moscow, Moskovskaja Oblast, Russian Federation
Group of companies "Medci", Moskva, Moskovskaja Oblast, Russian Federation
National Cancer Centre; Medical Oncology, Singapore, , Singapore
Curie Oncology, Singapore, , Singapore
Complejo Hospitalario de Navarra; Servicio de Oncologia, Pamplona, Navarra, Spain
Hospital Clínic i Provincial; Servicio de Oncología, Barcelona, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Changhua Christian Hospital, Chang Hua, , Taiwan
Taipei Veterans General Hospital; Department of Oncology, Taipei City, , Taiwan
National Taiwan University Hospital; Oncology, Zhongzheng Dist., , Taiwan
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc, Bangkok, , Thailand
Siriraj Hospital; Medical Oncology Unit, Bangkok, , Thailand
Songklanagarind Hospital; Department of Oncology, Songkhla, , Thailand
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology, Adana, , Turkey
Memorial Ankara Hastanesi, Ankara, , Turkey
Dicle Uni Medical Faculty; Internal Medicine, Diyarbakir, , Turkey
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department, Erzurum, , Turkey
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department, Malatya, , Turkey
Van Yuzuncu Yil University Hospital; Medical Oncology, Van, , Turkey
Ac?badem Altunizade Hastanesi; Oncology, Üsküdar, , Turkey
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs, Kharkiv, Kharkiv Governorate, Ukraine
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary, Sumy, , Ukraine
UCL Hospital NHS Trust, London, , United Kingdom
Christie Hospital Nhs Trust; Medical Oncology, Manchester, , United Kingdom
Nottingham City Hospital; Oncology, Nottingham, , United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre, Oxford, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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