A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer

Sponsor
University of Birmingham
Study ID
NCT03981146
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

An open-label, single-arm, phase II, multicentre clinical trial to determine the rate of durable clinical benefit of nivolumab in patients with class II expressing microsatellite stable colorectal cancer.

Key Dates

Start date
Aug 28, 2019
Status verified
Apr 2026
Primary completion
Nov 26, 2024
Completion
Nov 26, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Patients will receive 480mg of Nivolumab on a four weekly cycle for a maximum of two years.

Primary Outcome Measure

Durable Clinical Benefit [ Time Frame: Beginning of trial treatment to free of disease progression (104 weeks maximum) ]

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