A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer (NCT03981146) | Clinical Trial Compass
CompletedPhase 2
A Phase II Trial Assessing Nivolumab in Class II Expressing Microsatellite Stable Colorectal Cancer
United Kingdom35 participantsStarted 2019-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed locally advanced or metastatic MSS CRC with class II expression (greater than 1% cancer cell positivity for class II expression on immunohistochemistry).
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (APPENDIX 1)
* Age ≥ 18 years
* Patients must have completed all standard of care therapy that the treating oncologist deems appropriate. Trial treatment as first line therapy is permitted if the patient has declined standard of care therapy.
* CT scan of chest, abdomen, pelvis within 28 days of registration demonstrating unidimensionally measurable disease as per RECIST version 1.1 (APPENDIX 3).
* Demonstrate adequate haematological function:
* Platelet count ≥100 x 109 /L
* Neutrophils ≥1.5 x 109/L
* Haemoglobin ≥ 90 g/L
* Demonstrate adequate hepatic function:
* Serum bilirubin ≤1.5 x upper limit of normal (ULN)
* Serum AST or ALT ≤2.5 x ULN or \<5 x ULN in the presence of liver metastases
* Demonstrate adequate renal function
o Creatinine clearance \<1.5 times ULN and \>30ml/min (as per institutional standard).
* Provision of signed and dated, written informed consent prior to any trial specific procedures, sampling and analyses.
* Negative pregnancy test (female patients of reproductive potential). (Serum Test must be negative)
* Patients must agree to the use of contraception as detailed in section 7.8
Exclusion Criteria:
* Previous treatment with PD1/PDL1 inhibitors.
* Untreated sympto…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Durable Clinical Benefit
Timeframe: Beginning of trial treatment to free of disease progression (104 weeks maximum)