Клинические исследование Advanced or Metastatic Esophageal Squamous Cell Carcinoma: RO7121661, RO7247669, Nivolumab

Спонсоры	Ведущий спонсор: Hoffmann-La Roche
Источник	Hoffmann-La Roche
Краткое содержание	This is a Phase II, randomized, blinded, active-controlled, global, multicenter study designed to evaluate the safety and efficacy of RO7121661 and RO7247669, 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.

Общий статус

Recruiting

Дата начала

2021-06-25

Дата завершения

2024-10-15

Дата первичного завершения

2024-10-15

Фаза

Phase 2

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Overall Survival, Defined as the Time from Randomization to Death from Any Cause	Up to 3 years, 4 months

Вторичный результат

Мера	Временное ограничение
Number of Participants with Adverse Events, Severity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)	Up to 3 years, 4 months
Objective Response Rate (ORR), Defined as the Percentage of Participants with a Complete or Partial Response According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)	Up to 3 years, 4 months
Disease Control Rate (DCR), Defined as the Percentage of Participants with an Objective Response or Stable Disease According to RECIST v1.1	Up to 3 years, 4 months
Duration of Response for Participants with ORR, Defined as the Time from the First Occurrence of a Documented Objective Response to Disease Progression According to RECIST v1.1 or Death from any Cause, Whichever Occurs First	Up to 3 years, 4 months
Progression-Free Survival (PFS), Defined as the Time from Randomization to the First Occurrence of Progression as Determined According to RECIST v1.1 or Death from any Cause, Whichever Occurs First	Up to 3 years, 4 months
Percentage of Participants Reporting Clinically Meaningful Improvement in Global Health Status/Quality of Life (GHS/QoL), and Emotional and Social Functioning, Defined as a ≥10-Point Increase from Baseline as Measured by the EORTC QLQ-C30	Baseline (Day 1 of Cycle 1) and Day 1 of Cycles 4, 7, 10, and then every 6 cycles thereafter (each cycle is 14 days) until treatment discontinuation; and every 3 months during the first year of post-treatment follow-up (up to 3 years)
Percentage of Participants Reporting a Clinically Meaningful Improvement in GHS/QoL, and Emotional and Social Functioning, Defined as a ≥10-Point Increase from Baseline as Measured by the EORTC IL97 Questionnaire	Baseline (Cycle 1 Day 1) and Day 1 of Cycles 2, 3, 5, 6, 8, and 9 (each cycle is 14 days)
Percentage of Participants Reporting a Clinically Meaningful Improvement in Dysphagia, Defined as a ≥10-Point Increase from Baseline as Measured by the EORTC QLQ-OES18	Baseline (Cycle 1 Day 1) and Day 1 of each subsequent treatment cycle (each cycle is 14 days) until treatment discontinuation; and every 3 months during the first year of post-treatment follow-up (up to 3 years)
Serum Concentrations of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Area Under the Time-Serum Concentration Curve (AUC) of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Maximum Serum Concentrations of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Total Clearance of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Volume of Distribution at Steady State of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Terminal Half-Life of RO7121661, RO7247669, and Nivolumab	Predose and at end of infusion on Day 1 of every treatment cycle and on Day 8 of Cycles 1 and 5 (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Number of Participants with Anti-Drug Antibodies (ADAs) to RO7121661, RO7247669, or Nivolumab at Baseline and During the Study	Predose at Baseline (Day 1 of Cycle 1) and on Day 1 of Cycles 2, 3, 4, 5, and 7, and then every 3 cycles thereafter (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Change from Baseline in the Number of T-cell Subsets by Phenotype and Activation Status (CD4/CD8 HLA-DR+Ki67+) in the Peripheral Blood	Predose at Baseline (Day 1 of Cycle 1) and on Day 1 of Cycles 2, 3, 5, and 7, and then every 3 cycles thereafter (each cycle is 14 days); and at treatment discontinuation (up to 2 years)
Change from Baseline in the Number of CD8+ T-cells Infiltrating the Tumor Microenvironment	Baseline and Day 1 of Cycle 3 (each cycle is 14 days)
Change from Baseline in the Number of CD8+ T-cells Proliferating (CD8+Ki67+) in the Tumor Microenvironment	Baseline and Day 1 of Cycle 3 (each cycle is 14 days)
Baseline PDL1, CD8+PD1+, CD8+TIM3+, and CD8+LAG3+ Expression in the Tumor Microenvironment	At Baseline

Регистрация

255

Состояние	Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Вмешательство	Тип вмешательства: Drug Название вмешательства: RO7121661 Описание: 2100 milligrams (mg) administered by intravenous (IV) infusion once every 2 weeks on Day 1 of each 14-day cycle. Этикетка Arm Group: RO7121661 Тип вмешательства: Drug Название вмешательства: RO7247669 Описание: 2100 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle. Этикетка Arm Group: RO7247669 Тип вмешательства: Drug Название вмешательства: Nivolumab Описание: 240 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle. Этикетка Arm Group: Nivolumab Другое имя: Opdivo®
Приемлемость	Критерии: Inclusion Criteria: - Advanced or metastatic, histologically confirmed esophageal squamous-cell carcinoma (ESCC) - Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization; or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence within 24 weeks after the last dose of the treatment - Radiologically measurable disease according to RECIST v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - A life expectancy of at least (≥)12 weeks - Tissue samples must be provided for analysis of anti-programmed death ligand-1 (PD-L1) tumor positivity - Adverse events from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade ≤1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy - Adequate cardiovascular, hematological, liver, and renal function - Serum albumin ≥25 grams per liter (g/L), - For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time ≤1.5 times (×) the upper limit of normal (ULN); for participants receiving therapeutic anticoagulation: stable anticoagulant regimen - A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP), or a WOCBP who agrees to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization. - A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method and refrain from donating sperm during the treatment period and for at least 5 months after the final dose of study drug Exclusion Criteria: - Pregnancy, lactation, or breastfeeding - Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - Patients with significant malnutrition. Patients whose nutrition has been well controlled for ≥28 days prior to randomization may be enrolled - Evidence of complete esophageal obstruction not amenable to treatment - Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree) - Symptomatic central nervous system (CNS) metastases - Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for ≥14 days prior to randomization - Active or history of carcinomatous meningitis/leptomeningeal disease - Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization - Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry - Active second malignancy (with some exceptions) - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.). - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent - Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization - Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis [TB] and typical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 28 days prior to randomization - Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease. - Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications - Dementia or altered mental status that would prohibit informed consent - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (expected to occur once monthly or more frequently) - Active or history of autoimmune disease or immune deficiency - Positive human immunodeficiency virus (HIV) test at screening - Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening - Positive hepatitis C virus (HCV) antibody test at screening - Prior cancer therapy with any immunomodulatory agents including checkpoint inhibitors (CPIs; such as anti-PDL1/PD1, anti-CTLA-4, anti-LAG3, anti-TIM3) - Vaccination with live vaccines within 28 days prior to randomization, or anticipation that a live attenuated vaccine will be required during the study - Treatment with therapeutic oral or IV antibiotics within 14 days prior to randomization - Concurrent therapy with any other investigational drug (defined as treatment for which there is currently no regulatory authority approved indication) 28 days or 5 half-lives of the drug (whichever is shorter) prior to randomization - Treatment with immune-modulating and immune suppressive agents/medication 5 half-lives or 28 days (whichever is shorter) prior to randomization - Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease) - Radiotherapy within the last 28 days before start of study drug treatment is not allowed, with the exception of limited palliative radiotherapy - Prior treatment with adoptive cell therapies, such as chimeric antigen receptor T cells (CAR-T) therapies Пол: All Минимальный возраст: 18 Years Максимальный возраст: N/A Здоровые волонтеры: No

Состояние

Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Вмешательство

Тип вмешательства: Drug

Название вмешательства: RO7121661

Описание: 2100 milligrams (mg) administered by intravenous (IV) infusion once every 2 weeks on Day 1 of each 14-day cycle.

Этикетка Arm Group: RO7121661

Тип вмешательства: Drug

Название вмешательства: RO7247669

Описание: 2100 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.

Этикетка Arm Group: RO7247669

Тип вмешательства: Drug

Название вмешательства: Nivolumab

Описание: 240 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.

Этикетка Arm Group: Nivolumab

Другое имя: Opdivo®

Приемлемость

Критерии:

Inclusion Criteria: - Advanced or metastatic, histologically confirmed esophageal squamous-cell carcinoma (ESCC) - Patients who have previously received 1 line of treatment with either a fluoropyrimidine- and platinum- or a taxane- and platinum-based regimen in non-curative intention prior to randomization; or patients who received treatment with a fluoropyrimidine-/taxane- and platinum-based regimen in curative intention and had recurrence within 24 weeks after the last dose of the treatment - Radiologically measurable disease according to RECIST v1.1. Previously irradiated lesions should not be counted as target lesions unless clearly progressed after the radiotherapy - Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 - A life expectancy of at least (≥)12 weeks - Tissue samples must be provided for analysis of anti-programmed death ligand-1 (PD-L1) tumor positivity - Adverse events from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade ≤1, except alopecia (any grade), vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 peripheral neuropathy - Adequate cardiovascular, hematological, liver, and renal function - Serum albumin ≥25 grams per liter (g/L), - For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time ≤1.5 times (×) the upper limit of normal (ULN); for participants receiving therapeutic anticoagulation: stable anticoagulant regimen - A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP), or a WOCBP who agrees to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods during the treatment period and for at least 5 months after the final dose of study drug and have a negative pregnancy test (blood) within the 7 days prior to randomization. - A male participant must remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures such as a condom plus an additional contraceptive method and refrain from donating sperm during the treatment period and for at least 5 months after the final dose of study drug Exclusion Criteria: - Pregnancy, lactation, or breastfeeding - Known hypersensitivity to any of the components of RO7121661, RO7247669, or nivolumab, including but not limited to, hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies - Patients with significant malnutrition. Patients whose nutrition has been well controlled for ≥28 days prior to randomization may be enrolled - Evidence of complete esophageal obstruction not amenable to treatment - Higher risk of bleeding or fistula caused by esophageal lesions invading adjacent organs (aorta or tracheobronchial tree) - Symptomatic central nervous system (CNS) metastases - Spinal cord compression not definitively treated with surgery and/or radiation or without evidence that disease has been clinically stable for ≥14 days prior to randomization - Active or history of carcinomatous meningitis/leptomeningeal disease - Asymptomatic CNS primary tumors or metastases if they have requirement for steroids or enzyme inducing anticonvulsants in the last 28 days prior to randomization - Uncontrolled tumor-related pain. Participants requiring pain medication must be on a stable regimen at study entry - Active second malignancy (with some exceptions) - Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, known autoimmune diseases or immune deficiency, or other diseases with ongoing fibrosis (such as scleroderma, pulmonary fibrosis, emphysema, neurofibromatosis, palmar/plantar fibromatosis, etc.). - Encephalitis, meningitis, or uncontrolled seizures in the year prior to informed consent - Significant cardiovascular/cerebrovascular disease within 6 months prior to randomization - Known active or uncontrolled bacterial, viral, fungal, mycobacterial (including but not limited to tuberculosis [TB] and typical mycobacterial disease), parasitic, or other infection (excluding fungal infections of nail beds) or any major episode of infection requiring treatment with intravenous (IV) antibiotics or hospitalization (relating to the completion of the course of antibiotics, except if for tumor fever) within 28 days prior to randomization - Known clinically significant liver disease, including alcoholic hepatitis, cirrhosis, and inherited liver disease. - Major surgical procedure or significant traumatic injury (excluding biopsies) within 28 days prior to randomization, or anticipation of the need for major surgery during the course of the study - Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications - Dementia or altered mental status that would prohibit informed consent - Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (expected to occur once monthly or more frequently) - Active or history of autoimmune disease or immune deficiency - Positive human immunodeficiency virus (HIV) test at screening - Positive hepatitis B surface antigen (HBsAg) or positive total hepatitis B core antibody (HBcAb) test at screening - Positive hepatitis C virus (HCV) antibody test at screening - Prior cancer therapy with any immunomodulatory agents including checkpoint inhibitors (CPIs; such as anti-PDL1/PD1, anti-CTLA-4, anti-LAG3, anti-TIM3) - Vaccination with live vaccines within 28 days prior to randomization, or anticipation that a live attenuated vaccine will be required during the study - Treatment with therapeutic oral or IV antibiotics within 14 days prior to randomization - Concurrent therapy with any other investigational drug (defined as treatment for which there is currently no regulatory authority approved indication) 28 days or 5 half-lives of the drug (whichever is shorter) prior to randomization - Treatment with immune-modulating and immune suppressive agents/medication 5 half-lives or 28 days (whichever is shorter) prior to randomization - Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease) - Radiotherapy within the last 28 days before start of study drug treatment is not allowed, with the exception of limited palliative radiotherapy - Prior treatment with adoptive cell therapies, such as chimeric antigen receptor T cells (CAR-T) therapies

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

N/A

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
Clinical Trials	Study Director	Hoffmann-La Roche

Общий контакт

Фамилия: Reference Study ID Number: BP42772 https://forpatients.roche.com/

Телефон: 888-662-6728 (U.S. Only)

Расположение

Объект:	Положение дел:
Inst. Alexander Fleming; Oncologia \| Buenos Aires, C1426ANZ, Argentina	Recruiting
UZ Antwerpen \| Edegem, 2650, Belgium	Recruiting
UZ Leuven Gasthuisberg \| Leuven, 3000, Belgium	Recruiting
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda \| Ijui, RS, 98700-000, Brazil	Recruiting
Hospital das Clinicas - UFRGS \| Porto Alegre, RS, 90035-903, Brazil	Recruiting
Beneficencia Portuguesa de Sao Paulo \| Sao Paulo, SP, 01323-900, Brazil	Recruiting
Masarykův onkologický ústav; Klinika komplexní onkologické péče \| Brno, 656 53, Czechia	Recruiting
Fakultni nemocnice Olomouc; Onkologicka klinika \| Olomouc, 779 00, Czechia	Recruiting
Rigshospitalet; Onkologisk Klinik \| København Ø, 2100, Denmark	Recruiting
Odense Universitetshospital, Onkologisk Afdeling R \| Odense C, 5000, Denmark	Recruiting
Institut Bergonie; Oncologie \| Bordeaux, 33076, France	Recruiting
Hopital Claude Huriez; Medecine Interne Oncologie \| Lille, 59037, France	Recruiting
Institut régional du Cancer Montpellier \| Montpellier, 34298, France	Recruiting
APHP - Hopital Saint Antoine \| Paris, 75571, France	Recruiting
Universitaetsklinikum Leipzig \| Leipzig, 04103, Germany	Recruiting
Klinikum Mannheim III. Medizinische Klinik \| Mannheim, 68167, Germany	Recruiting
Klinikum Bogenhausen; Klinik für Gastroenterologie, Hepatologie und Gastroenterologische Onkologie \| München, 81925, Germany	Recruiting
Gemeinschaftspraxis für Hämatologie und Onkologie \| Münster, 48153, Germany	Withdrawn
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet; Megyei Onkologiai Kozpont \| Szolnok, 5004, Hungary	Recruiting
Università degli Studi della Campania Luigi Vanvitelli; Divsione Di Oncologia Medica \| Napoli, Campania, 80131, Italy	Recruiting
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS \| Meldola, Emilia-Romagna, 47014, Italy	Recruiting
Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della \| Udine, Friuli-Venezia Giulia, 33100, Italy	Recruiting
Policlinico Universitario "Agostino Gemelli"; U.O.C. Oncologia Medica \| Roma, Lazio, 00168, Italy	Recruiting
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda \| Padova, Veneto, 35128, Italy	Recruiting
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma \| Verona, Veneto, 37134, Italy	Recruiting
International Cancer Institute (ICI) \| Eldoret, 30100, Kenya	Recruiting
Aga Khan University Hospital \| Nairobi, 00100, Kenya	Recruiting
Chonnam National University Hwasun Hospital \| Jeollanam-do, 58128, Korea, Republic of	Recruiting
Seoul National University Bundang Hospital \| Seongnam-si, 13605, Korea, Republic of	Recruiting
Severance Hospital, Yonsei University Health System \| Seoul, 03722, Korea, Republic of	Recruiting
Asan Medical Center \| Seoul, 05505, Korea, Republic of	Recruiting
Korea University Guro Hospital \| Seoul, 08308, Korea, Republic of	Recruiting
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny \| Brzozów, 36-200, Poland	Recruiting
Centrum Onkologii w Bydgoszczy \| Bydgoszcz, 85-796, Poland	Recruiting
Szpital Morski im. PCK; Poradnia Onkologiczna \| Gdynia, 81-519, Poland	Recruiting
Krakowski Szpital Specjalistyczny im. Jana Pawła II; Oddz. Klin. Chir. Klatki Piersiowej i Onkol. \| Kraków, 31-202, Poland	Recruiting
NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii \| Warszawa, 02-034, Poland	Recruiting
MEDSI Clinical Hospital on Pyatnitsky Highway; Department of antitumor drug therapy \| Moscow, Moskovskaja Oblast, 143422, Russian Federation	Recruiting
Group of companies "Medci" \| Moskva, Moskovskaja Oblast, 105229, Russian Federation	Recruiting
First Moscow State Medical University n.a. I.M. Sechenov \| Moscow, 119991, Russian Federation	Recruiting
Bashkirian Republican Clinical Oncology Dispensary \| UFA, 450054, Russian Federation	Active, not recruiting
National Cancer Centre; Medical Oncology \| Singapore, 169610, Singapore	Recruiting
Curie Oncology \| Singapore, 329563, Singapore	Recruiting
Limpopo Oncology Clinic \| Polokwane, 0700, South Africa	Recruiting
Complejo Hospitalario de Navarra; Servicio de Oncologia \| Pamplona, Navarra, 31008, Spain	Recruiting
Hospital Clínic i Provincial; Servicio de Oncología \| Barcelona, 08036, Spain	Recruiting
Hospital Ramon y Cajal; Servicio de Oncologia \| Madrid, 28034, Spain	Recruiting
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia \| Valencia, 46010, Spain	Recruiting
Changhua Christian Hospital \| Chang Hua, 500, Taiwan	Recruiting
Taipei Veterans General Hospital; Department of Oncology \| Taipei City, 112201, Taiwan	Recruiting
National Taiwan University Hospital; Oncology \| Zhongzheng Dist., 10048, Taiwan	Recruiting
Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc \| Bangkok, 10400, Thailand	Recruiting
Siriraj Hospital; Medical Oncology Unit \| Bangkok, 10700, Thailand	Recruiting
Songklanagarind Hospital; Department of Oncology \| Songkhla, 90110, Thailand	Active, not recruiting
Memorial Ankara Hastanesi \| Ankara, 06520, Turkey	Recruiting
Dicle Uni Medical Faculty; Internal Medicine \| Diyarbakir, 10000, Turkey	Recruiting
Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department \| Erzurum, 25240, Turkey	Recruiting
Inonu University Medical Faculty Turgut Ozal Medical Center Medical Oncology Department \| Malatya, 44280, Turkey	Recruiting
Van Yuzuncu Yil University Hospital; Medical Oncology \| Van, 65000, Turkey	Recruiting
Acıbadem Altunizade Hastanesi; Oncology \| Üsküdar, 34662, Turkey	Recruiting
Communal Non profit Enterprise Regional Center of Oncology; Oncosurgical dept of thoracic organs \| Kharkiv, Kharkiv Governorate, 61070, Ukraine	Recruiting
CI of Kherson Regional Council Kherson Regional Oncology Dispensary \| Kherson, Kherson Governorate, 73000, Ukraine	Recruiting
Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary \| Sumy, 40005, Ukraine	Recruiting
MI Zaporizhzhia Regional Clinical Oncological Dispensary Zaporizhzhia SMU Ch of Oncology \| Zaporizhzhya, 69040, Ukraine	Recruiting
Nottingham City Hospital; Oncology \| Nottingham, NG5 1PB, United Kingdom	Recruiting

Расположение Страны	Argentina Belgium Brazil Czechia Denmark France Germany Hungary Italy Kenya Korea, Republic of Poland Russian Federation Singapore South Africa Spain Taiwan Thailand Turkey Ukraine United Kingdom
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Имеет расширенный доступ	No
Состояние Просмотр	Carcinoma Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma Esophageal Neoplasms
Количество рук	3
Группа вооружений	Метка: RO7121661 Тип: Experimental Метка: RO7247669 Тип: Experimental Метка: Nivolumab Тип: Active Comparator
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

A Study of RO7121661 and RO7247669 Compared With Nivolumab in Participants With Advanced or Metastatic Squamous Cell Carcinoma of the Esophagus