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Also known as PD-1 blockade
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...
The PD-1 blocking antibody is being studied in nasopharyngeal carcinoma, a cancer of the upper throat. Bristol-Myers Squibb Company is developing it in this oncology indication. The program is in Phase 2 development, and the completed trial enrolled 152 patients with nasopharyngeal carcinoma in China.
Bristol-Myers Squibb Company, which trades under the ticker BMY, is the developer of the PD-1 blocking antibody. The company is studying the agent in nasopharyngeal carcinoma. The program has reached Phase 2 development, with one completed trial conducted in China.
The PD-1 blocking antibody is in Phase 2 development for nasopharyngeal carcinoma. It is investigational and is not approved for this use. One Phase 2 trial has been completed, and no trials are currently active. That completed study enrolled 152 patients and was conducted in China.
The PD-1 blocking antibody has been studied in one completed Phase 2 trial, NCT03984357, titled Nivolumab Combined With Chemoradiotherapy Sparing Concurrent Cisplatin in Nasopharyngeal Carcinoma. It enrolled 152 patients aged 18 years and older in China. The study was uncontrolled and not randomized, and no trials are currently active.
The PD-1 blocking antibody is investigational and remains in clinical development, so it is not approved for nasopharyngeal carcinoma. Its only recorded trial is a completed Phase 2 study, NCT03984357, which enrolled 152 patients in China. No active trials are ongoing for this program.