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
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Nivolumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer|
|Actual Study Start Date :||August 28, 2019|
|Estimated Primary Completion Date :||February 28, 2023|
|Estimated Study Completion Date :||February 28, 2023|
Patients will receive 480mg of Nivolumab on a four weekly cycle for a maximum of two years.
60 Minute IV Infusion
- 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
- Objective response [ Time Frame: trial treatment until disease progression (104 weeks maximum) ]Objective response is the occurrence of CR or PR as the best overall response
- Best Percentage Change in Sum of Target Lesions [ Time Frame: Trial Treatment to disease progression (104 weeks maximum) ]At each evaluation, the longest diameters of all selected target lesions will be measured and summed and the percentage change from the baseline measurement will be calculated. The best percentage change is the one that reflects either the greatest decrease or the least increase over the whole period of assessment.
- Time to Maximal Response [ Time Frame: Occurrence of CR or PR during the trial (104 weeks maximum) ]This is defined as the time from commencement of trial treatment to the date of CT scan that first records the best objective response as per RECIST version 1.1.
- Progression Free Survival Time [ Time Frame: time from commencement of trial treatment to the date of CT scan when progressive disease first recorded (104 weeks maximum) ]This is defined as the time from commencement of trial treatment to the date of CT scan when progressive disease first recorded or date of death without previously recorded progression.first records the best objective response as per RECIST version 1.1.
- Overall Survival Time [ Time Frame: Trial Treatment to date of death. ]This is defined as the time from commencement of trial treatment to the date of death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981146
|Belfast City Hospital|
|Belfast, United Kingdom|
|Queen Elizabeth Hospital|
|Birmingham, United Kingdom|
|Velindre Cancer Centre|
|Cardiff, United Kingdom|
|Western General Hospital|
|Edinburgh, United Kingdom|
|St James Leeds|
|Leeds, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, United Kingdom, LE1 5WW|
|Clatterbridge Cancer Centre|
|Liverpool, United Kingdom|
|The Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|London, United Kingdom|
|The Royal Marsden NHS Foundation Trust|
|London, United Kingdom|
|University College Hospital|
|London, United Kingdom|
|The Christie Hospital, The Christie NHS Foundation Trust|
|Manchester, United Kingdom|
|Newcastle Upon Tyne, United Kingdom|
|Sheffield, United Kingdom, S10 2SJ|
|Principal Investigator:||Gary Middleton, MB,BS,FRCP||University of Birmingham|