Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II 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.

Trial Details

NCT ID

NCT07070479

Phase

PHASE2

Sponsor

Ming-Yuan Chen

Status

RECRUITING

Cancer Type

Nasopharyngeal Head and Neck Cancer

Interventions

Ivonescimab
Nimotuzumab
Irinotecan liposome
S-1
Mitoxantrone Hydrochloride Liposome
PD-1 Inhibitors

Locations (sample)

Guangzhou, Guangdong, China|23.11667,113.25
Guangzhou, Guangdong, China|23.11667,113.25
Guangzhou, Guangdong, China|23.11667,113.25
Zhongshan, Guangdong, China|22.52306,113.37912
Zhuhai, Guangdong, China|22.27694,113.56778

Key Eligibility Criteria

Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undiffere…
Age between 18 and 70 years.
Performance Status (PS) score of 0 or 1.
Disease progression after prior platinum-based doublet chemotherapy.

For full eligibility, visit ClinicalTrials.gov.

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