Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMing-Yuan Chen
About this trial
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 criteria
Qualifiers
Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).
Age between 18 and 70 years.
Performance Status (PS) score of 0 or 1.
Disease progression after prior platinum-based doublet chemotherapy.
Disqualifiers
Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.
Prior treatment with any regimen included in the study protocol.
Prior use of agents targeting the VEGF or VEGFR pathway.
Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ.
Trial design
Treatments tested in this trial
- Ivonescimab
- Nimotuzumab
- Irinotecan liposome
- S-1
- Mitoxantrone Hydrochloride Liposome
- PD-1 Inhibitors
Treatment groups
208 Participants
are divided into 4 treatment groupsSponsors and collaborators
Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov