Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Key Facts

Primary Endpoints (CT.gov)

Secondary Endpoints

Eligibility Criteria

Inclusion Criteria: 1. Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III). 2. Age between 18 and 70 years. 3. Performance Status (PS) score of 0 or 1. 4. Disease progression after prior platinum-based doublet chemotherapy. 5. Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy, or treatment completion may be counted as first-line treatment.) 6. Resistance to anti-PD-1 antibody therapy (either combination or sequential), including primary or secondary resistance（PD-1 exposure must be at least 6 weeks.） 7. At least one measurable lesion according to RECIST 1.1 criteria. 8. All acute toxicities from prior anti-tumor therapies have resolved to grade ≤1 (per NCI-CTCAE v5.0) or meet the specified inclusion/exclusi…

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Source