Study on Nivolumab, Ipilimumab, and Radiation for Microsatellite Stable Pancreatic Cancer
Sponsor: Massachusetts General Hospital
ClinicalTrials ID:NCT04361162
This clinical trial is exploring the effects of combining two immunotherapy drugs, nivolumab and ipilimumab, with radiation therapy to treat pancreatic cancer that is microsatellite stable. The study aims to determine if this combination is safe and effective in controlling the cancer.
Patient Parameters
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Program Overview
This study is testing a new treatment approach for pancreatic cancer that does not have a specific genetic feature called microsatellite instability. The treatment combines two immunotherapy drugs, nivolumab and ipilimumab, with radiation therapy. The goal is to see if this combination can safely and effectively treat the cancer. Participants will be involved in the study for as long as the treatment is beneficial and will be followed for up to five years. About 30 people are expected to participate.
Description
This Phase II clinical trial is investigating the safety and effectiveness of combining the immunotherapy drugs nivolumab and ipilimumab with radiation therapy for treating microsatellite stable pancreatic cancer. Participants will undergo screening to determine eligibility and will receive the study treatment, which includes regular evaluations and follow-up visits. The study will continue as long as the treatment is safe and beneficial for the participants, with follow-up lasting up to five years.
Nivolumab and ipilimumab are antibodies that help the immune system fight cancer. Nivolumab works by causing cancer cells to die, while ipilimumab helps prevent cancer cells from growing. Radiation therapy may enhance the effectiveness of these drugs. Although these drugs are not yet approved by the FDA for this specific type of pancreatic cancer, they are approved for other uses.
Eligibility Criteria
Inclusion Criteria
- Must have confirmed metastatic pancreatic cancer that is microsatellite stable.
- Be over 18 years old.
- Have a performance status score of less than 2, indicating good overall health.
- Have a life expectancy of more than 3 months.
- Have normal organ and bone marrow function based on specific blood tests.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- Men must use effective contraception if sexually active with women of childbearing potential.
- Be able to understand and sign a consent form.
- Have a stable dose of certain medications if applicable.
- Have at least one tumor that can be treated with radiation and another measurable tumor outside the radiation area.
- Must have previously received at least one line of chemotherapy.
Exclusion Criteria
- Have received chemotherapy or other treatments within 14 days before starting the study.
- Have active autoimmune diseases, except for certain conditions like vitiligo or type I diabetes.
- Require systemic treatment with corticosteroids or other immunosuppressive drugs.
- Have previously received anti-CTLA-4 therapy.
- Have active tuberculosis, hepatitis B or C, or HIV.
- Have uncontrolled illnesses like heart failure or psychiatric conditions.
- Are pregnant or breastfeeding.
- Have another progressing cancer that requires treatment.
- Have active lung inflammation or infection.
- Have received a live vaccine within 30 days before starting the study.
- Have a history of severe allergic reactions to study drugs or antibodies.
- Have uncontrolled brain metastases.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Massachusetts General Hospital | 02114 | Boston | Massachusetts |
| Beth Israel Deaconess Medical Center | 02215 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
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