NCT04575922

Nivolumab+Ipilimumab+RT in MSS mCRC

Nivolumab and Ipilimumab and Radiation Therapy in Metastatic, Microsatellite Stable Colorectal Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research is being done to study the effects of the combination of ipilimumab, nivolumab, and radiation therapy in people with metastatic microsatellite stable colorectal cancer. This research study involves the following drugs and interventions: * Ipilimumab * Nivolumab * Radiation Therapy

Detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied. The U.S. Food and Drug Administration (FDA) has not approved the combination of ipilimumab and nivolumab for metastatic microsatellite stable colorectal cancer but they have been approved for other uses. The FDA has not approved ipilimumab for metastatic microsatellite stable colorectal cancer, but it has been approved for other uses. The FDA has not approved nivolumab for metastatic microsatellite stable colorectal cancer, but it has been approved for other uses. Ipilimumab and Nivolumab are both genetically-engineered antibodies. An antibody is a protein that can attach to specific molecular targets. Ipilimumab and nivolumab work by activating the immune system, which can help to fight certain cancers. This trial explores whether radiation therapy may increase the benefit from immune activation with ipilimumab and nivolumab. The research study procedures include screening for eligibility, and study treatment including evaluations and follow up visits. Participants will be in this research study for as long as the study interventions are safe and beneficial. Participants will then be followed for up to 5 years. It is expected that about 30 people will take part in this research study. Bristol-Myers Squibb, a pharmaceutical company, is supporting this research study by providing funding for this study, including the two study drugs.

Conditions

• Metastatic Microsatellite Stable Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Administered into vein by intravenous infusion every 2 weeks over 6 week study cycle.
DRUG	Ipilimumab	Administered into vein by intravenous infusion day 1 of each 6 week study cycle.
RADIATION	Radiation Therapy	3 radiation treatments, every other weekday or 2 days during week 1 of cycle 1 only of study.

Timeline

• Start date: 2020-10-05
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2020-10-05
• Last updated: 2022-09-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study