Cetuximab Combined With Pembrolizumab or Finotonlimab and Chemotherapy in R/M HNSCC
Sponsor: Ji Dongmei • ClinicalTrials.gov ID: NCT07509099
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This is an open-label, randomized, prospective, multicenter phase III trial to evaluate the efficacy and safety of the combination therapy of cetuximab with either pembrolizumab or finotonlimab, alongside chemotherapy, as a first-line treatment, compared with pembrolizumab or finotonlimab with chemotherapy for R/M HNSCC.
Interventions
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cetuximab+PD-1 mAb(Pembrolizumab/Finotonlimab)+chemotherapy
(Drug)
Cetuximab: 400 mg/m2 initial dose followed by 250 mg/m2 (weekly), iv, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Pembrolizumab or Finotonlimab:200mg, iv, administered on Day 1, Q3W, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Nab-paclitaxel: 260 mg/m², iv over 30 minutes, administered on Day 1, Q3W, for a maximum of 6 cycles. Cisplatin: 75 mg/m², iv (hydration), administered on Day 1, repeated Q3W (if cisplatin-related non-hematological toxicity occurs, treatment may switch to carboplatin area under the curve(AUC)=5; if cisplatin intolerant patients, carboplatin(AUC=5) could be used), for a maximum of 6 cycles.
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PD-1 mAb (Pembrolizumab/Finotonlimab) + chemothearpy
(Drug)
Pembrolizumab or Finotonlimab:200mg, iv, administered on Day 1, Q3W, until disease progression, intolerable toxicity, or the subject voluntarily requests to discontinue the trial treatment. Nab-paclitaxel: 260 mg/m², iv over 30 minutes, administered on Day 1, Q3W, for a maximum of 6 cycles. Cisplatin: 75 mg/m², iv (hydration), administered on Day 1, repeated Q3W (if cisplatin-related non-hematological toxicity occurs, treatment may switch to carboplatin area under the curve(AUC)=5; if cisplatin intolerant patients, carboplatin(AUC=5) could be used), for a maximum of 6 cycles.
Eligibility criteria
Conditions
Locations
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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