| Major lesion was 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 c |
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 |
80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
18 Year(s) |
80 Year(s) |
Both |