NCT03813394

Bevacizumab and Pembrolizumab Combination in Platinum-resistant Recurrent/Metastatic NPC

A Randomised Phase II Study of Pembrolizumab With or Without Bevacizumab in Platinum-resistant Recurrent/Metastatic Nasopharyngeal Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, randomized, phase Ib/II open-label study of pembrolizumab (pembro or MK-3475) with or without bevacizumab in patients with recurrent non-curable or metastatic nasopharyngeal carcinoma (NPC).

Detailed description

The study will consist of 2 treatment arms. In Treatment Arm A, patients will be treated with intravenous pembrolizumab alone, 21-day cycle. For Treatment Arm B, patients will receive intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle). Each treatment cycle is 3 weeks. Up to 48 patients will be enrolled in this study in 2 stages. The first stage will consist of 30 patients and the remaining 18 patients will be added if interim data looks promising. Eligible patients will be randomized 1:1 into either Treatment Arm A or Arm B. Treatment will continue until tumor progression, intolerance to treatment, or up to 2 years (32 doses of pembrolizumab/bevacizumab). For patients who have progressed on pembrolizumab alone, cross over to Arm B is allowed, with repeat biopsy of the lesions before and 1 week after starting bevacizumab. Patients who discontinue from the trial will not be replaced. The study will collect serial samples of tumor tissue and blood to determine the PD biomarkers of immune activation, in the tumor and systemically, following treatment. This is expected to provide preliminary evidence for immune stimulation using both pembrolizumab and bevacizumab in NPC. The tumor biopsies will also present an opportunity to determine the molecular details of tissue and tumor response to anti-angiogenic therapy.

Conditions

• Locally Recurrent Cancer
• Metastatic Nasopharyngeal Cancer

Interventions

Type	Name	Description
DRUG	pembrolizumab	-Pembrolizumab in Solution for Injection
DRUG	bevacizumab	* Bevacizumab in Concentrate for Solution * Bevacizumab in Concentrate for Solution

Timeline

• Start date: 2019-05-01
• Primary completion: 2024-07-31
• Completion: 2025-06-01
• First posted: 2019-01-23
• Last updated: 2024-11-22

Locations

1 site across 1 country: Singapore