A Multi-center, Randomized, Double-blind, Phase II/III Clinical Trial of AK104 or Placebo in Combination With Chemotherapy as Second-line or More Lines for Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC)

ConditionRecurrent or Metastatic Nasopharyngeal Carcinoma

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSun Yat-sen University

About this trial

To compare whether AK104 combined with GP or PFLL can improve survival benefit, safety and tolerability in nasopharyngeal carcinoma patients who have failed first-line treatment; To compare the survival benefits of GP or GFLL treatment in nasopharyngeal carcinoma patients who had failed first-line therapy; To compare the survival benefits of GP or GFLL combined with AK104 in patients with nasopharyngeal carcinoma who had failed first-line therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

GP/PFLL+AK104
Drug
Groups 1 and 2: Patients who have not been treated with PFLL in front-line therapy. 5-Fu:200mg/m2/d, d1-30, continuous intravenous infusion; Cisplatin: 80mg/m2, intravenous infusion for 4h, the first and 28th days of each cycle; AK104: 6mg/kg intravenous infusion for more than 60 minutes, used on days 1, 15, 30, 45 of each cycle, and administered 30 minutes before chemotherapy drugs during chemotherapy. Groups 3 and 4: Patients who had never used GP in their front-line treatment regimen. Gemcitabine: 1000mg/m2, used on the 1st and 8th day of each cycle; Cisplatin: 80mg/m2 on the first day of each cycle; AK104 6mg/kg intravenous infusion for more than 60 minutes was used on day 1, 15 (single cycle)/or day 8 (double cycle) of each cycle, and was administered 30 minutes before chemotherapy drugs during chemotherapy. Every 3 weeks is a treatment cycle, with a maximum of 6 cycles used. After 6 cycles of chemotherapy, both groups could continue to receive AK104 (once every 2 weeks).
GP/PFLL+placebo
Drug
Groups 1 and 2: Patients who have not been treated with PFLL in front-line therapy. 5-Fu:200mg/m2/d, d1-30, continuous intravenous infusion; Cisplatin: 80mg/m2, intravenous infusion for 4h, the first and 28th days of each cycle; placebo: 6mg/kg intravenous infusion for more than 60 minutes, used on days 1, 15, 30, 45 of each cycle, and administered 30 minutes before chemotherapy drugs during chemotherapy. Groups 3 and 4: Patients who had never used GP in their front-line treatment regimen. Gemcitabine: 1000mg/m2, used on the 1st and 8th day of each cycle; Cisplatin: 80mg/m2 on the first day of each cycle; placebo 6mg/kg intravenous infusion for more than 60 minutes was used on day 1, 15 (single cycle)/or day 8 (double cycle) of each cycle, and was administered 30 minutes before chemotherapy drugs during chemotherapy. Every 3 weeks is a treatment cycle, with a maximum of 6 cycles used. After 6 cycles of chemotherapy, both groups could continue to receive placebo (once every 2 weeks).

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: AK104Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

PFS

Progression-free survival

Time frame

24 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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