A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer (ANICCA)
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ClinicalTrials.gov Identifier: NCT03981146 |
Recruitment Status :
Active, not recruiting
First Posted : June 10, 2019
Last Update Posted : September 16, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | May 9, 2019 | ||||
First Posted Date ICMJE | June 10, 2019 | ||||
Last Update Posted Date | September 16, 2021 | ||||
Actual Study Start Date ICMJE | August 28, 2019 | ||||
Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Durable Clinical Benefit [ Time Frame: Beginning of trial treatment to free of disease progression (104 weeks maximum) ] patient will be defined as experiencing DCB if they remain free of disease progression at their third trial specific CT scan since treatment start date (i.e. at approximately 27 weeks) or at any CT scan after 27 weeks that shows the patient remains free of disease progression
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer | ||||
Official Title ICMJE | A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer | ||||
Brief Summary | 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. | ||||
Detailed Description | Immuno-oncology is transforming the care of certain patients with cancer. Not all patients respond to these therapies however, and in some common cancers checkpoint blockade has failed to make any real impact. In 2014 there were over 41,000 new cases of colorectal cancer (CRC) in the UK and nearly 16,000 deaths from the disease, making it the second commonest cause of cancer death (Cancer Research UK Cancer Statistics Key Facts). 15% of patients with CRC develop it as a result of deficient mismatch repair (microsatellite instability - MSI): this cohort of patients respond well to PD-1/PD-L1 blockade as these tumours harbour a very high number of mutations thus increasing the likelihood of the presence of immunogenic neo-epitopes which elicit an immune response1. The majority of CRC patients, particularly those with metastatic disease (around 95%), do not display this hyper-mutator phenotype (microsatellite stable (MSS) CRC) and in these patients the results of PD-1/PD-L1 blockade have been disappointing. In summary, MSS CRC patients with a class II expression appear to represent immunologically a group of MSI-like MSS patients that may respond to usefully to the immunotherapy agent nivolumab as a single agent and thus a trial of nivolumab in patients with class II expression of their cancer cells appears to be highly justified. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | ||||
Intervention ICMJE | Drug: Nivolumab
60 Minute IV Infusion
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Study Arms ICMJE | Experimental: Nivolumab
Patients will receive 480mg of Nivolumab on a four weekly cycle for a maximum of two years.
Intervention: Drug: Nivolumab
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
35 | ||||
Original Estimated Enrollment ICMJE |
36 | ||||
Estimated Study Completion Date ICMJE | February 28, 2023 | ||||
Estimated Primary Completion Date | February 28, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03981146 | ||||
Other Study ID Numbers ICMJE | RG_17-215 2018-000318-39 ( EudraCT Number ) 40245896 ( Registry Identifier: ISRCTN ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | University of Birmingham | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | University of Birmingham | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Bristol-Myers Squibb | ||||
Investigators ICMJE |
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PRS Account | University of Birmingham | ||||
Verification Date | September 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |