REduced Frequency ImmuNE Checkpoint Inhibition in Cancers

Sponsor
University College, London
Study ID
NCT04913025
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    60-minute IV infusion, as a flat dose of 480mg
  • Pembrolizumab — DRUG
    60-minute IV infusion, as a flat dose of 400mg

Study Details

The REFINE trial aims to asses whether giving an immunotherapy drug less-often to patients with advanced cancer, results in fewer side effects whilst continuing to be an effective treatment. The question will be assessed in different tumour types by means of different cohorts within an overarching trial protocol.

Key Dates

Start date
May 26, 2022
Status verified
Sep 2022
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

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

Arms

  • Active Comparator: Standard interval
    Standard of care regimen Nivolumab administered as an approximate 60-minute IV infusion, as a flat dose of 480mg once every 4 weeks OR Pembrolizumab administered as an approximate 60-minute IV infusion, as a flat dose of 400mg once every 6 weeks
  • Experimental: Extended interval
    Nivolumab administered as an approximate 60-minute IV infusion, as a flat dose of 480mg once every 8 weeks OR Pembrolizumab administered as an approximate 60-minute IV infusion, as a flat dose of 400mg once every 12 weeks

Primary Outcome Measure

Progression Free Survival [ Time Frame: 1 year 9 months follow-up ]

Central Contacts

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