RecruitingPhase 2NCT05305131

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

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


Sponsor

National University Hospital, Singapore

Enrollment

50 participants

Start Date

Mar 28, 2022

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 21 MonthsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two treatment approaches for advanced nasopharyngeal cancer (a cancer at the back of the nose and throat): standard induction chemotherapy (gemcitabine + cisplatin) versus a 4-drug combination that adds pembrolizumab (immunotherapy) and bevacizumab (anti-blood vessel drug). **You may be eligible if...** - You are 21 or older with a confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma - Your cancer is at an advanced but locally controlled stage (stage III–IVA) with no distant spread - Your tumor tests positive for Epstein-Barr virus (EBV) - You have measurable disease on imaging scans **You may NOT be eligible if...** - Your cancer has spread to distant organs (metastatic stage IVB or IVC) - Your cancer is EBV-negative - You have significant heart or organ problems that make the 4-drug combination unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGcisplatin and gemcitabine

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

DRUGinduction 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05305131


Related Trials