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

Sponsor
National University Hospital, Singapore
Study ID
NCT03813394
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Recurrent Cancer
  • Metastatic Nasopharyngeal Cancer

Eligibility Criteria

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

Interventions

  • pembrolizumab — DRUG
    -Pembrolizumab in Solution for Injection
  • bevacizumab — DRUG
    * Bevacizumab in Concentrate for Solution * Bevacizumab in Concentrate for Solution

Study Details

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).

Key Dates

First listed
Jan 23, 2019
Start date
May 1, 2019
Status verified
Nov 2024
Primary completion
Jul 31, 2024
Completion
Jun 1, 2025

Study Design

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

Arms

  • Experimental: Treatment Arm A
    Intravenous pembrolizumab alone,D8 of 21-day cycle.
  • Experimental: Treatment Arm B
    Intravenous pembrolizumab preceded by an infusion of bevacizumab (Day 1 of 21-day cycle).

Primary Outcome Measure

Primary endpoint of ORR [ Time Frame: 2 years ]