Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma (NCT07565389) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Singapore42 participantsStarted 2026-05
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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)
✓. Must have seen at least 1 prior line of systemic treatment and has progressed on prior platinum-based chemotherapy and anti-PD1 therapy in the R/M setting OR Progressed within 6 months of previous multimodal therapy containing platinum-based chemotherapy and anti-PD1 therapy in the locally advanced setting.
✓. Has measurable disease based on iRECIST.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Has an adequate organ function as defined in the following table (table 1). Specimens must be collected within 10 days prior to the start of study treatment
Exclusion criteria
✕. 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.
✕. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
✕. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
✕. Has hypersensitivity to ivonescimab or any of its components.
✕. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.