Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
A Bayesian Adaptive Phase II Randomized Trial Comparing Ivonescimab, Ivonescimab Plus Nimotuzumab, Liposomal Mitoxantrone Plus Anti-PD-1 Antibody, and Liposomal Irinotecan Plus S-1 in Patients With PD-1-Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma
Ming-Yuan Chen
208 participants
Jun 24, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy. The four treatment arms include: 1. Ivonescimab monotherapy, 2. Ivonescimab combined with nimotuzumab, 3. Liposomal mitoxantrone plus anti-PD-1 antibody, and 4. Liposomal irinotecan plus S-1.
Eligibility
Plain Language Summary
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Interventions
Ivonescimab 10 mg/kg via intravenous infusion, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.
Nimotuzumab 400 mg via intravenous infusion, Q3W, until the occurrence of intolerable toxicity, withdrawal of informed consent, initiation of new antitumor therapy, loss to follow-up, or death, whichever occurs first.
Irinotecan liposome 50mg/m2 via intravenous infusion, D1, D15, Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
S-1, D1-D14, BID, p.o., (BSA \< 1.25 m2, 40 mg/dose; 1.25 m2 ⩽ BSA \< 1.5 m2, 50 mg/dose; BSA ⩾ 1.5 m2, 60mg/dose), Q4W for up to 6 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
Mitoxantrone hydrochloride liposome 20mg/m2 via intravenous infusion, Q3W for up to 8 cycles or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first
PD-1 blockade (comprising tislelizumab \<200 mg/cycle\>, carrellimab \<200 mg/cycle\>, or toripalimab \<240 mg/cycle\>) , Q3W for two years, or until intolerable toxicity, subject withdrawal of informed consent, diseases progression, initiation of new antitumor therapy, loss of follow-up, or death, whichever occurs first.
Locations(6)
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NCT07070479