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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 99
Healthy Volunteers: f
View:

• The participant (or legally acceptable representative if applicable) provides written consent for the trial.

• Participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC).

• Have measurable disease based on RECIST 1.1.

• Tumour stage III (except for T3N0 and T3N1) or IVA according to the American Joint Committee on Cancer (AJCC) 8th edition criteria.

• Have locally or centrally determined EBV-positive NPC by EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \[ISH\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required.

• Note: If EBV status by EBER ISH assay has not been previously determined, tumor tissue from archival tissue may be submitted for EBV determination.

• Did not receive any prior treatment

• Willingness to donate blood for mandatory translational research studies.

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Have an adequate organ function

⁃ A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

∙ Not a woman of childbearing potential (WOCBP) as defined in Appendix 3 of study protocol OR

‣ A WOCBP who agrees to follow the contraceptive guidance in Appendix 3 of study protocol during the treatment period and for at least 120 days after the last dose of study medication.

⁃ A male participant must agree to use a contraception as detailed in Appendix 3 of study protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.

Locations
Other Locations
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
Wan Qin Chong, MBBS, MRCP, M Med
wan_qin_chong@nuhs.edu.sg
6772 4614
Time Frame
Start Date: 2022-03-28
Estimated Completion Date: 2026-12-28
Participants
Target number of participants: 50
Treatments
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.
Authors
Jia Li Low, Qin Jian Low
Related Therapeutic Areas
Sponsors
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov

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