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PD-1 blocking antibody · 1 trial · 1 indication
Failure-free survival is measured from day of enrollment until the first indication of treatment failure (either locoregional recurrence or distant metastasis) or death from any cause, whichever occurred first
| Arm | Type | Description |
|---|---|---|
| PD-1 blocking antibody combined with IC+IMRT | EXPERIMENTAL | All participants will receive induction chemotherapy (IC; every 3 weeks × 3 cycles; gemcitabine 1000 mg/m2 day 1, 8 + cisplatin 80 mg/m2 day 1) followed by intensity-modulated radiotherapy (IMRT; 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day) alone. PD-1 blocking antibody (360 mg per cycle) will start on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of IMRT, involving the whole-course of IC + IMRT alone. The first and last 3 cycles of PD-1 blocking antibody are administrated concurrently with IC and IMRT, respectively. After 4 weeks of the completion of IMRT, adjuvant PD-1 blocking antibody (480 mg per cycle) will begin every 4 weeks for 6 cycles. |
| Name | Type | Description |
|---|---|---|
| PD-1 blocking antibody | DRUG | 1. Whole-course concurrent PD-1 blocking antibody: every 3 weeks × 6 cycles; 360 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of IMRT, involving the whole-course of IC + IMRT alone. 2. Adjuvant PD-1 blocking antibody: every 4 weeks × 6 cycles; 480 mg, day 1 |
| Gemcitabine | DRUG | Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles |
| Cisplatin | DRUG | Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles |
| Intensity-modulated radiotherapy | RADIATION | Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day |
Inclusion Criteria: 1. Age: 18 to 65; 2. Pathological type: non-keratinizing carcinoma (World Health Organization criteria); 3. Diagnosed with LANPC (T4N1, T1-4N2-3) according to the 8th edition clinical staging system of the American Joint Committee on Cancer \[AJCC\]/Union for International Cance...
PD-1 blocking antibody is being studied for the treatment of Nasopharyngeal Carcinoma. It is an investigational therapy in Phase 2 clinical development, evaluated in a completed trial that enrolled 152 participants in China. The drug is intended to be used in combination with chemoradiotherapy, specifically sparing concurrent cisplatin, for this indication.
PD-1 blocking antibody is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical research on this investigational therapy for Nasopharyngeal Carcinoma, with a Phase 2 trial completed in China.
PD-1 blocking antibody is in Phase 2 clinical development. It is an investigational drug, not yet approved, and is being studied for Nasopharyngeal Carcinoma. A Phase 2 trial has been completed, but the drug remains in clinical development and has not received regulatory approval.
PD-1 blocking antibody has one completed clinical trial, NCT03984357, titled 'Nivolumab Combined With Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma.' This Phase 2 study enrolled 152 participants in China, with a minimum age of 18 years, and included both sexes. The trial was not randomized or double-blinded and had no control group.
PD-1 blocking antibody is described in the clinical trial as nivolumab, a PD-1 inhibitor. The trial NCT03984357 specifically evaluates nivolumab combined with chemoradiotherapy in Nasopharyngeal Carcinoma. The drug is being developed by Bristol-Myers Squibb and is in Phase 2 clinical development.