Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors (NCT03693846) | Clinical Trial Compass
TerminatedPhase 2
Nivolumab and Ipilimumab in Mucinous Colorectal and Appendiceal Tumors
Stopped: Terminated due to slow enrollment and lack of efficacy
United States11 participantsStarted 2019-02-15
Plain-language summary
This is a single-arm phase II study of twenty-one subjects with mucinous adenocarcinoma of the colon, rectum, or appendix with prior systemic therapy with a fluoropyrimidine, oxaliplatin, and irinotecan. Treatment will consist of nivolumab 480mg every 4 weeks and ipilimumab 1mg/kg every 8 weeks until disease progression, unacceptable toxicity, or 2 years of therapy.
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:
* Subjects must have signed and dated an IRB-approved written informed consent form prior to the performance of any protocol-related procedures that are not part of standard care.
* Colorectal or appendiceal mucinous adenocarcinoma with peritoneal-only metastatic disease. It is recognized that in some patients, peritoneal disease will predominate without distinction of the site of origin, and such patients will be eligible.
* Microsatellite stable by PCR and/or mismatch repair proficient by immunohistochemistry
* ECOG performance status of 0 or 1
* Prior therapy with a fluoropyrimidine, oxaliplatin, and irinotecan unless contraindicated or refused. Prior treatment with antiangiogenic and/or anti-EGFR antibody therapy is permitted but not required
* Measurable disease by RECIST v. 1.1
* Laboratory parameters:
* Absolute neutrophil count \> 1500/μL
* Platelets \> 100,000/μL
* Hemoglobin \> 9.0 g/dL
* PT/INR or PTT \< 1.5xULN
* Creatinine \< 1.5xULN OR creatinine clearance \> 50 mL/min by Cockcroft-Gault formula
* Total bilirubin \< 1.5xULN
* Subjects with Gilbert's Syndrome must have a total bilirubin level of \< 3.0xULN
* Albumin \> 3.0 g/dL
* AST and/or ALT: \< 3.0×ULN
* Subjects with HIV are permitted provided they meet the following criteria:
* CD4+ cell count \> 250 cells/mm3
* No history of AIDS-defining conditions other than low CD4+ count
* If subject is on antiretroviral therapy, there must not be expected significant drug…
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
Number of Participants With Progression-Free Survival at 6 Months
Timeframe: Start of treatment until 6 months later