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RECRUITING
NCT05305131
PHASE2

Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer

Sponsor: National University Hospital, Singapore

View on ClinicalTrials.gov

Summary

The investigators hypothesize that the addition of bevacizumab and pembrolizumab to induction cisplatin and gemcitabine is tolerable and improves metabolic complete response (mCR), relapse free survival (RFS) and overall survival (OS) compared to induction cisplatin and gemcitabine in patients with locally advanced nasopharyngeal cancer (NPC)

Official title: Phase II Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer

Key Details

Gender

All

Age Range

21 Months - 99 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-03-28

Completion Date

2026-12-28

Last Updated

2025-09-23

Healthy Volunteers

No

Interventions

DRUG

cisplatin and gemcitabine

Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2

DRUG

induction chemotherapy cisplatin, gemcitabine, bevacizumab and pembrolizumab.

Day -7 (+/-1 day): IV bevacizumab 7.5mg/kg diluted in normal saline over 30 minutes Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2+ IV pembrolizumab 200mg over 30 minutes Day 8: IV Gemcitabine 1000mg/m2 Day 15 (for cycles 1 and 2 only): IV bevacizumab 7.5mg/kg diluted in normal saline over 30 minutes

Locations (1)

National University Hospital

Singapore, Singapore