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

Sponsor
National University Hospital, Singapore
Study ID
NCT05305131
Phase
PHASE2
Status
Recruiting
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Conditions

  • Nasopharyngeal Cancer

Eligibility Criteria

Sex
ALL
Age
21 Months - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • cisplatin and gemcitabine — DRUG
    Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2
  • induction chemotherapy cisplatin, gemcitabine, bevacizumab and pembrolizumab. — DRUG
    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

Study Details

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)

Key Dates

First listed
Mar 31, 2022
Start date
Mar 28, 2022
Status verified
Mar 2025
Primary completion
Dec 28, 2025
Completion
Dec 28, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction cisplatin and gemcitabine
    Each treatment cycle is 3 weeks. All patients would receive 3 cycles of induction chemotherapy as part of the study, and would then be considered for subsequent concurrent chemoradiotherapy at the investigator's discretion. Cross over is not allowed.
  • Experimental: induction chemotherapy cisplatin, gemcitabine, bevacizumab and pembrolizumab
    Each treatment cycle is 3 weeks. All patients would receive 3 cycles of induction chemotherapy as part of the study, and would then be considered for subsequent concurrent chemoradiotherapy at the investigator's discretion. Cross over is not allowed.

Primary Outcome Measure

metabolic complete response assessed using FDG PET whole body scan at 12 weeks of assessment using PERCIST 1.0 [ Time Frame: up to 3 years ]

Central Contacts

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