Evaluating Ivonescimab in PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma

Starting soon · Phase 2

Conditions studied: Nasopharyngeal Carcinoma (NPC)

In brief

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.

Key facts

Study ID: NCT07565389
Run by: National University Hospital, Singapore
People needed: 42
Starts: 2026-05-01
Expected to finish: 2031-05-01
Last updated by the study team: 2026-05-04

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Participant is eligible to be included in the study only if all the following criteria are met:
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
Willing to provide blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.

You may not qualify if…

Participant is excluded from the study if ANY of the following criteria apply:
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.
Note: Inhaled or topical steroids and adrenal replacement doses <10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Patients are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted if < or = 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
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).
Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc) is not considered a form of systemic treatment.
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.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
Has an active infection requiring systemic therapy, or serious non-healing wound, ulcer or bone fracture.
Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of ≥ 3 anti-hypertensive drugs or systolic blood pressure greater than 150 mmHg).
Recent cardiovascular thromboembolic event, such as the following:
Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment
Symptomatic pulmonary embolism ≤ 4 weeks before enrolment
Any history of acute myocardial infarction ≤ 6 months before enrolment
Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) ≤ 6 months before enrolment
Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment
Any history of cerebrovascular accident ≤ 6 months before enrolment
Persistent proteinuria of NCI-CTCAE Grade 3 or higher (> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample).
Clinically significant bleeding (NCI-CTCAE Grade 3 or higher) within 30 days prior to start of study medication.
Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.

Where it is running

National University Cancer Institute, Singapore, National University Health System — Singapore, Singapore

Full record on ClinicalTrials.gov

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