This study is designed as a single-arm, open-label, phase II trial to evaluate the efficacy and safety of ivonescimab in patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) who have progressed on prior an immune checkpoint inhibitor and platinum-based chemotherapy.
The participant (or legally acceptable representative if applicable) provides written consent for the trial.
Participant is at least 21 years of age on the day of signing informed consent
Has a locally or centrally determined histologically or cytologically confirmed diagnosis of Epstein Barr Virus (EBV)-positive nasopharyngeal carcinoma Note: The EBV status is to be determined by the EBV-encoded small RNA in situ hybridization (EBER in situ hybridization [ISH]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required. If EBV status by EBER ISH assay has not been previously determined, tumour tissue from archival tissue may be submitted for EBV determination.
Has recurrent or metastatic (R/M) disease not amenable to curative local therapy (surgery or radiation)
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
Has prior anti-angiogenic therapy in the R/M setting or within 6 months as part of multimodality therapy in the locally advanced setting. [Applies to cohort A only]
Has tumour that encases major arteries which in the opinion of the investigator carries high risk of vessel wall dehiscence.
Has a condition requiring systemic steroid therapy (> 10 mg daily prednisone equivalents) or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
Single group
Ivonescimab 20 mg/kg
DrugSubjects will receive intravenous ivonescimab at a dose of 20 mg/kg administered every 3 weeks until disease progression, intolerable toxicities, or withdrawal from the study.
Objective Response Rate (ORR)
Objective Response Rate (ORR), defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) as assessed by investigator review using iRECIST
Progression-Free Survival (PFS)
defined as time from first dose of ivonescimab to documented disease progression or death from any cause, whichever occurs first, as assessed by iRECIST.
Overall Survival (OS)
defined as time from first dose of ivonescimab to death from any cause.
Duration of Response (DoR)
defined as time from the first documentation of objective response (Complete response or Partial response) to disease progression or death.
Disease Control Rate (DCR)
defined as the proportion of patients achieving Complete Response (CR) + Partial Response (PR) + Stable disease for at least 12 weeks.
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This trial is not recruiting at the moment. You can still explore other options:
