Clinical trial results for
advanced colorectal cancer
(MSI-H/dMMR)
For certain adults and children 12 years and older who have MSI-H/dMMR colorectal cancer that cannot be removed by surgery or has spread to other parts of the body (metastatic)
Actor portrayals.
OPDIVO + YERVOY is not approved
for people younger than 12 years of age.
The first FDA-approved combination of two immunotherapies that helped people live significantly longer without their cancer progressing compared to other treatment groups in the clinical trial
About the clinical trial
This clinical trial included 839 people with advanced MSI-H/dMMR colorectal cancer and compared OPDIVO + YERVOY to either OPDIVO alone or investigator’s choice of chemotherapy.
In the one group, 354 people were given OPDIVO + YERVOY and 353 people were given OPDIVO alone.
In the other group, 202 people were given OPDIVO + YERVOY and 101 people were given investigator's choice of chemotherapy. Investigators in this trial were able to choose between giving modified FOLFOX-6 (leucovorin, fluorouracil, and oxaliplatin) with or without targeted therapy (bevacizumab or cetuximab) or FOLFIRI (irinotecan, leucovorin, and fluorouracil) with or without targeted therapy (bevacizumab or cetuximab). For more information about this trial, talk to your healthcare professional.
People given OPDIVO + YERVOY lived significantly longer without their cancer spreading, growing, or getting worse compared to investigator's choice chemotherapy at ~2.5 years
OPDIVO + YERVOY
More than half the people went without their cancer spreading, growing, or getting worse
Investigator's choice chemotherapy
Half the people went without their cancer spreading, growing, or getting worse
People given OPDIVO + YERVOY had a 79% lower risk of cancer spreading, growing, or getting worse than those given chemotherapy.
People given OPDIVO + YERVOY lived significantly longer without their cancer spreading, growing, or getting worse compared to OPDIVO alone at ~4 years
OPDIVO + YERVOY
More than half the people went without their cancer spreading, growing, or getting worse
OPDIVO alone
Half the people went without their cancer spreading, growing, or getting worse
People given OPDIVO + YERVOY had a 38% lower risk of cancer spreading, growing, or getting worse than those given OPDIVO alone.
Words to know
MSI-H is an acronym for microsatellite instability-high. Microsatellites are sections of DNA arranged in a certain order within a cell. The order can change when cells make mistakes repairing themselves. A cell is considered MSI-H when many sections are out of order.
dMMR is an acronym for deficient mismatch repair. Cells in your body have a mismatch repair (MMR) system, which can fix inconsistencies in their DNA when DNA is being copied within the cell. dMMR means that this system is deficient or not functioning properly. This can result in tumors with high microsatellite instability (MSI-H).
Progression means that a disease, such as cancer, has spread, grown, or gotten worse.
Not reached means that in the time period of the clinical trial, over 50% of the people in the treatment group did not have their cancer spread, grow, or get worse.
OPDIVO + YERVOY will not work for everyone. Individual results may vary.
Getting an infusion
See your recommended treatment plan and what to expect from an infusion
For adults and children 12 years of age and older with advanced MSI-H/dMMR CRC
OPDIVO® (nivolumab) is a prescription medicine that may be used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
It is not known if OPDIVO is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO is safe and effective in children for the treatment of any other cancers.