BP42772

Inclusiecriteria: U mag meedoen als

• Age >=18 years
• Participants whose 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 Response evaluation criteria in solid tumors version 1.1 (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 >=12 weeks
• Tissue samples must be provided for analysis of anti–programmed death-1 (PD-L1) tumor positivity.
• Adequate cardiovascular function
• AEs from any prior radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade • Adequate hematological function
• Adequate liver function
• Adequate renal function
• Serum albumin >=25 grams per liter (g/L),
• For participants not receiving therapeutic anticoagulation: prothrombin time (PT) and activated partial thromboplastin time • Male and/or female participants. A female participant is eligible to participate if she is not pregnant, not breastfeeding, not a woman of childbearing potential (WOCBP) and WOCBP, who agree 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 during the treatment period and for at least 5 months after the final dose of study drug

Exclusiecriteria: U mag niet meedoen als

• 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) Metastase Meer informatie over de term "Metastase" Metastase (of uitzaaiing) is de verspreiding van tumorcellen vanuit de oorspronkelijke locatie (de primaire locatie) naar een ander deel van het lichaam. Tumoren kunnen metastaseren (uitzaaien) door nabijgelegen weefsel binnen te dringen of door zich te verspreiden via de circulatie (bloed en lymfestelsel). s
• 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 Metastase Meer informatie over de term "Metastase" Metastase (of uitzaaiing) is de verspreiding van tumorcellen vanuit de oorspronkelijke locatie (de primaire locatie) naar een ander deel van het lichaam. Tumoren kunnen metastaseren (uitzaaien) door nabijgelegen weefsel binnen te dringen of door zich te verspreiden via de circulatie (bloed en lymfestelsel). s 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
• Patients with an active second malignancy
• 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 an

y immunomodulatory agents including checkpoint inhibitor (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

• UZ Leuven Campus Gasthuisberg
• UZ Antwerpen