NCT04361162

Nivolumab + Ipilimumab + Radiation in MSS Pancreatic Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• 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 microsatellite stable pancreatic cancer. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab * Radiation Therapy

Detailed description

This research study is a Phase II clinical trial study testing the safety and effectiveness of the combination of ipilimumab, nivolumab, and radiation therapy. 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. The names of the study interventions involved in this study are: * Ipilimumab * Nivolumab * Radiation Therapy It is expected that about 30 people will take part in this research study. Ipilimumab and Nivolumab are both antibodies. An antibody is a protein that attaches to other cells to fight off infection. The antibodies in ipilimumab work by not allowing cancer cell growth. The antibodies in nivolumab work by causing programmed cell death of the cancer cells. Radiation therapy may increase the likelihood of response to interventions like ipilimumab and nivolumab. The U.S. Food and Drug Administration (FDA) has not approved ipilimumab and nivolumab for microsatellite stable pancreatic cancer. but they have been approved for other uses.

Conditions

• Pancreatic Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
DRUG	Ipilimumab	Ipilimumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
RADIATION	Radiation	3D Conformal Radiotherapy to shrink or kill tumors

Timeline

• Start date: 2020-05-18
• Primary completion: 2022-10-01
• Completion: 2026-10-01
• First posted: 2020-04-24
• Last updated: 2022-09-08

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study