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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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
3D Conformal Radiotherapy to shrink or kill tumors
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Overall response rate (ORR)
Overall response rate (ORR) will be evaluated by RECIST. Nivolumab and ipilimumab combined with radiation will be considered to have promising activity in metastatic MSS pancreatic cancer if at least 3 of 30 patients were to achieve CR or PR.
Time frame: 6 weeks
Disease control rate (DCR)
Disease control rate (DCR) will be based on RECIST and estimated with 95% confidence intervals based on the exact binomial distribution.
Time frame: Up to 5 yrs
Number of Participants with Treatment Related Adverse Events as Assessed NCI CTCAE 5.0 guidelines
Toxicity rates associated with the protocol treatment of nivolumab and ipilimumab combined with radiation will be summarized by category and grade.
Time frame: Up to 5 years
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the duration from the first day of protocol treatment to the earliest date of tumor progression by RECIST, appearance of new metastases, or death due to any cause. PFS time will be censored at the date of last follow-up for patients still alive with disease control. The PFS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Time frame: Up to 5 years
Overall survival (OS) in patients
Overall survival (OS) is defined as the duration from the first day of protocol treatment to the date of death due to any cause and will be censored at the date of last follow-up for patients still alive. The OS rate will be estimated using the Kaplan-Meier method with 95% confidence intervals based on the complementary log-log transformation.
Time frame: Up to 5 years
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