Actively Recruiting
Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer
Led by National University Hospital, Singapore · Updated on 2025-09-23
50
Participants Needed
1
Research Sites
248 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Randomised Trial of Induction Gemcitabine and Cisplatin Versus Gemcitabine, Cisplatin, Pembrolizumab and Bevacizumab (GPPB) in Nasopharyngeal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant provides written consent for the trial.
- At least 21 years old at signing informed consent with confirmed non-keratinizing nasopharyngeal carcinoma.
- Measurable disease based on RECIST 1.1.
- Tumor stage III (except T3N0 and T3N1) or IVA per AJCC 8th edition.
- Locally or centrally confirmed EBV-positive NPC by EBER in situ hybridization.
- No prior treatment for NPC.
- Willing to donate blood for research.
- ECOG performance status of 0 or 1.
- Adequate organ function.
- Female participants not pregnant, not breastfeeding, and either not of childbearing potential or agree to contraception during and 120 days after treatment.
- Male participants agree to contraception during and 120 days after treatment and refrain from sperm donation.
You will not qualify if you...
- Stage III NPC with T3N0 or T3N1.
- Prior systemic anti-cancer therapy including chemotherapy, radiotherapy, immunotherapy, or investigational agents.
- Participation in another investigational study or use of investigational device within 4 weeks before treatment.
- Need for systemic steroid therapy >10 mg prednisone daily or other immunosuppressive therapy within 14 days before treatment.
- Active autoimmune disease requiring systemic treatment in past 2 years.
- History or current pneumonitis requiring steroids.
- Hypersensitivity to bevacizumab or its components.
- Additional progressing malignancy requiring treatment within past 3 years, except certain skin or in situ cancers.
- Active infection requiring systemic therapy or serious non-healing wounds.
- Uncontrolled hypertension despite medication.
- History of significant cardiac disease or arrhythmias requiring treatment.
- Persistent proteinuria Grade 3 or higher.
- Clinically significant bleeding within 30 days before treatment.
- Conditions or abnormalities interfering with trial participation.
- Psychiatric or substance abuse disorders interfering with cooperation.
- Pregnant or breastfeeding, or planning pregnancy during study.
- Positive pregnancy test within 72 hours before randomization for women of childbearing potential.
- Known HIV infection.
- Known active Hepatitis B or C infection.
- Receipt of live vaccine within 30 days before first study drug dose.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National University Hospital
Singapore, Singapore
Actively Recruiting
Research Team
W
Wan Qin Chong, MBBS, MRCP, M Med
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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