This randomized controlled trial aims to evaluate the efficacy and safety of Becotatug Vedotin (MRG003), an antibody-drug conjugate (ADC), combined with the PD-1 inhibitor Pucotenlimab as induction therapy for high-risk locoregionally advanced nasopharyngeal carcinoma (NPC), compared to the standard gemcitabine and cisplatin (GP) regimen combined with Pucotenlimab, followed by concurrent chemoradiotherapy (CCRT) and adjuvant immunotherapy.
1. Age ≥ 18 years at the time of diagnosis, regardless of sex
1. History of any other malignancy within the past 5 years, with the exception of curatively treated cervical carcinoma in situ, papillary thyroid carcinoma, or basal cell carcinoma of the skin
Parallel
Becotatug Vedotin
DrugInduction Therapy: Becotatug Vedotin (MRG003) 2.0 mg/kg, intravenous infusion, Day 1 (3 cycles, Q3W)
Pucotenlimab
DrugInduction Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (3 cycles, Q3W); Adjuvant Therapy: Pucotenlimab 200 mg, intravenous infusion, Day 1 (6 cycles, Q3W)
Gemcitabine + cisplatin (GP)
DrugInduction Therapy (3 cycles, Q3W): Gemcitabine 1000 mg/m², intravenous infusion, Days 1 and 8 Cisplatin 80 mg/m², intravenous infusion, Day 1
intensity-modulated radiotherapy
Radiation70 Gy in 33 fractions, once daily, 5 days per week
Cisplatin
DrugConcurrent Cisplatin: 100 mg/m², intravenous infusion, Day 1 (2 cycles, Q3W) during radiation
Post-induction Therapy Complete Response Rate (post-IT CRR)
The proportion of patients achieving complete response following induction therapy
Event-Free Survival (EFS)
From date of randomization until the date of first documented locoregional recurrence, distant metastasis, or death from any cause, whichever occurred first.
Overall survival (OS)
From date of enrollment to date of death from any cause
Distant Metastasis-Free Survival (DMFS)
From date of enrollment to date of first documented distant metastasis
Locoregional Recurrence-Free Survival (LRRFS)
From date of enrollment to date of first documented locoregional recurrence
Adverse Events (AEs)
Graded according to CTCAE V5.0
Correlation of Tumor, Peripheral Blood, and Fecal Biomarkers with Treatment Efficacy and Patient Prognosis
Tumor tissue biomarkers: EGFR expression level, PD-L1 expression level, tumor-infiltrating lymphocyte (TIL) density, immune score, expression profiles of immune checkpoint molecules and immune cell subpopulations, and tumor cell transcriptomic gene expression； Peripheral blood biomarkers: Immune cell populations, immune repertoire, and cytokine profiles； Fecal biomarkers: Composition and characteristics of fecal biomarkers in relation to treatment response and prognosis
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
