Phase 2 Trial of Ipilimumab and Nivolumab in Nasopharyngeal Carcinoma

Sponsor
National Cancer Centre, Singapore
Study ID
NCT03097939
Phase
PHASE2
Status
Unknown

Conditions

  • Nasopharyngeal Carcinoma

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ipilimumab — DRUG
    1 mg/kg of IV Ipilimumab is admistered over 90 minutes every 6 weeks
  • Nivolumab — DRUG
    3 mg/kg of IV Nivolumab is administered over 30 minutes every 2 weeks

Study Details

The purpose of this study is to test the hypothesis that a combined Immuno-Oncology (IO) strategy would see efficacy in a virally driven cancer like Nasopharyngeal Carcinoma (NPC). Hence, this is a combination study of nivolumab and ipilimumab in Epstein-Barr virus (EBV) driven nasopharyngeal carcinoma.

Key Dates

Start date
Mar 31, 2017
Status verified
Oct 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
113 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab and Ipilimumab

Primary Outcome Measure

Best Overall Response Rate (BOR) by RECIST [ Time Frame: From the start of treatment until disease progression/recurrence, up to 2 years ]

Central Contacts

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