This trial is evaluating whether Nivolumab will improve 2 primary outcomes and 19 secondary outcomes in patients with Colorectal Cancer. Measurement will happen over the course of Up to 5 years.
This trial requires 831 total participants across 3 different treatment groups
This trial involves 3 different treatments. Nivolumab is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.
"Most patients with microsatellite instability treated in our clinic had no change in cancer risk with the available therapies on the market at the time. Most also required additional treatments, including surgery and/or radiation-based therapy. Results from a recent clinical trial of the present study raise the possibilities of other treatment approaches that could improve survival rate for patients with microsatellite instability." - Anonymous Online Contributor
"In a population-based survey, the presence of MSI was significantly associated with advanced [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) and other tumor types. In particular, MSI was more frequent in subjects with stage III, IV, and distal cancers, and it also was associated with the presence of high-grade and microsatellite-stable cancers. To further explore this phenomenon as a biological marker, patients with microsatellite instability in the future may be considered for adjuvant chemotherapy at the time of surgery." - Anonymous Online Contributor
"In our study, two-third of colonic lesions in HNPCC had an underlying MSI-like state. We suggest that the presence of MSI-H foci and mismatch repair defects in colonic cells are possible biomarkers for HNPCC. Thus, MSI may be a useful adjunct to the clinical diagnosis of colonic cancer in patients with HNPCC." - Anonymous Online Contributor
"Microsatellite Instability seems to be a common problem with colorectal cancers, and is found to occur in about 15% of colonic adenomas. This suggests that this is an important link in a carcinogenic pathway." - Anonymous Online Contributor
"The vast majority of people with colorectal cancers with stable microsatellite instability show no further malignant disease, but some tumors have changed the genotype when compared to benign adenomas. These changes may be due to underlying differences in gene expression, and in the majority of cases the genetic changes are not evident by conventional methods of gene dosage analysis." - Anonymous Online Contributor
"Microsatellite instability is a common genetic marker for familial breast and colorectal cancer, possibly due to germline mutations in mismatch repair genes. There is some evidence for germline microsatellite instability being associated with colorectal cancer. Microsatellite instability, as measured by the polymerase chain reaction method, may have clinical usefulness in identifying individuals at risk for breast and colorectal cancer." - Anonymous Online Contributor
"It is the first FDA-approved anti-PD-1 therapy for H. pylori-associated gastritis and peptic ulcer disease, but has not yet been determined to be effective in treating gastroesophageal cancer or other neoplasms. The safety and efficacy of nivolumab in the treatment of H. pylori-associated gastritis and peptic ulcer disease are currently being evaluated in two double-blind Phase III studies with over 12,000 participants. Additional clinical studies are ongoing to establish whether the antibody may be useful in treating gastroesophageal cancers (http://clinicaltrials." - Anonymous Online Contributor
"We summarize the most common side effects of Nivolumab in patients with advanced or metastatic colorectal cancer, lung cancer, and renal cell carcinoma. The side effects are similar to those observed with any antibody, and all side effects appear to be related to inhibition of PD1. The most common side effects are fatigue, decreased appetite, nausea, abdominal pain, diarrhoea, rash, itch, low blood cell count, and constipation." - Anonymous Online Contributor
"Most women with MSI-H gastro-oesophageal cancers have a shortened overall survival, whereas some with MSI-L may have an expected long-term survival rate similar to that for women without MSI." - Anonymous Online Contributor
"Treatment with nivolumab was associated with significant improvement in the quality of life of patients with MSI, including an improvement in patient reported pain scores." - Anonymous Online Contributor
"There are currently two ongoing clinical trials for nivolumab; NCT01574463 and NCT02154816. These trials are not related to each other and enrollment into both trials is open to everyone with advanced metastatic cancer." - Anonymous Online Contributor